Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Gland and Hormone Related Diseases

Rare Diseases

Pain, Postoperative

Ovarian Neoplasms

Carcinoma, Ovarian Epithelial

Pain

Ovarian Cancer

Ovarian Epithelial Cancer

Central Nervous System Depressants

All Drugs and Chemicals

Anesthetics

Bupivacaine

"ESP block group" ,Patients received preoperative US guided ESP block on BOTH sides to be operated upon 30 minutes before being transferred to the OR

"TAB group" ,Patients received bilateral lower TAB 30 min before being transferred to the OR

"the control group", Patients will not receive any block.

A volume of 20 ml for each side of erector spinae plane with 0.25% plain bupivacaine

erector spinae block

A volume of 20 ml for each side of transversus abdominis plane with 0.25% plain bupivacaine

transversus abdominis block

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature.

Hypothesis Analgesia provided by the erector spine plane block is superior to that of transversus abdominis block in patients undergoing ovarian cancer surgery under general anesthesia.

Introduction:

Postoperative pain is one of the greatest patient concerns following any surgery. Although an increased emphasis has been placed on pain management, approximately 80% of surgical patients report postoperative pain with 86% of patients rating their pain as moderate, severe, or extreme.

In recent years, the increasing adoption of ultrasound-guided regional anesthesia for acute pain management parallels the rapid rise in the availability of ultrasound machines, facilitating description of a number of important fascial plane blocks blocking the dorsal, lateral and anterior cutaneous nerves of the thorax and abdomen. These new descriptions in blocks are supposed to be an advance in regional anesthesia due to its simplicity and lack of complications. These include the transversus abdominis plane block, rectus sheath block, quadratus lumborum block, pectoralis nerve block, serratus plane block, retrolaminar block, and now the Erector spinae block.

The TAP is a potential anatomical space that lies between transversus abdominis and internal oblique muscles, where local anesthetic can be deposited, creating a non-dermatomal "field block.".This block can be placed before or during a surgery either by ultrasound guidance or by landmarking through the triangle of Petit (inferior lumbar triangle). Blocks can be placed either intra-abdominally prior to abdominal fascial closure or by transdermal injection. Transversus abdominis plane (TAP) blocks can provide reliable relief of somatic incisional pain. However, the lack of reliable visceral pain relief with TAP blocks may necessitate additional modes of analgesia.

Previous studies have investigated the efficacy of TAP blocks in benign gynecology, general surgery,and non-ovarian gynecologic oncology.These studies have had mixed outcomes, but a recent meta-analysis has demonstrated an overall reduction in pain and opioid usage associated with TAP blocks in laparotomy.

Since its first description by Forero et al. there have been many articles and case reports including an increasingly number of indications for the ESP block: chronic and acute pain treatment , rib fractures management in the emergency setting, treatment of abdominal surgical pain , hip arthroplasty , analgesic management in breast surgery,or in spinal surgery.

The ESP block targets the erector spinae plane, which lies between the anterior surface of the cephalon-caudal oriented erector spinae muscles (that arise from and insert into various bony components of the vertebral column, for example, from spinous process to spinous process, rib to rib, and transverse process to transverse process and the posterior surface of the spinal transverse processes. LA is deposited in the fascial plane deep to the erector spinae muscle and superficial to the tips of the transverse processes, from where it diffuses to the dorsal and ventral rami of spinal nerves, achieving an extensive multi-dermatomal sensory block of the posterior, lateral, and anterior thoracic wall .

ESP block could result in both visceral and somatic abdominal analgesia if the injection were performed at a lower thoracic level.as the local anesthetic penetrates anteriorly through the intertransverse connective tissue and enters the thoracic paravertebral space where it can potentially block not only the ventral and dorsal rami of spinal nerves but also the rami communicants that transmit sympathetic fibers.

For 2019 about 22,530 women will receive a new diagnosis of ovarian cancer and about 13,980 women will die from ovarian cancer as for The American Cancer Society estimation for ovarian cancer in the United States. oncologic ovarian cancer surgeries performed by general anesthesia (GA),cannot provide adequate postoperative pain control as cytoreductive and staging procedures often involve considerable visceral disruption and incisions above the umbilicus have accessory innervation. and the routine use of parenteral opioids aggravates postoperative sedation, nausea, emesis, impaired oxygenation and depressed ventilation.

Although ESP and TAB blocks successfully reduced postoperative opioid consumption in previous studies, no study has ever compared their efficacy in postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia thus in this randomized controlled study we are aiming to fill this gap in the literature.

Aim of the work Aims to evaluate the analgesic effects of combined general with ultrasound-guided erector spinae block versus that of combined general with transversus abdominis block in patients undergoing major ovarian cancer surgery 1. Inclusion criteria female Patients undergoing ovarian cancer surgery under general anesthesia with ASA I-II and Age ≥ 18 and ≤ 65 Years 2. Exclusion criteria

* Patient refusal.
* uncooperative patients
* Cardiovascular disease in the form of Uncontrolled hypertension, IHD, AF, cardiomyopathy with EF \<50%
* Cerebrovascular insufficiency in the form of TIAs, REND, stroke, cerebral hemorrhage, brain tumour, epilepsy
* Coagulation defects with INR\>1.5 platelets count\< 80000
* hepatic insufficiency with ALT and AST \> twice normal, total bilirubin \>1.5 , PC \< 80%.
* Hypersensitivity to the study drugs.
* Pregnant patients
* patients receiving vasoactive drugs or beta blockers V. Study Procedures

  1. Randomization (in RCT only) Computer generated sequence will be used for randomization.
  2. Study Protocol After approval of the Research Ethics Committee and written informed consent from all patients, A randomized, prospective, comparative, single blinded as the anesthesiologist who will collect data will be blinded for which block was given study to compare between ultrasound-guided erector spinae plane block and transversus abdominis plane block for postoperative analgesia of adult patients undergoing ovarian cancer surgery under general anesthesia with lower midline incision approach will be conducted on A total of 45 Patients that will be randomly allocated by using computer generated random numbers into Group1: (n=15) "ESP block group" ,Patients received preoperative US guided ESP block on BOTH sides to be operated upon 30 minutes before being transferred to the OR, Group 2: (n=15) "TAB group" ,Patients received bilateral lower TAB 30 min before being transferred to the OR and Group 3: (n=15)"the control group", Patients will not receive any block.

The day before surgery, all patients will be instructed to fast for 6-8 hours. On the day of the operation, the patient will arrive to the preparation room 1 hour before operation, to allow time for the block procedure and a minimum of 30 minutes to pass after the block before induction of general anesthesia, an 18 G cannula insertion, a start of IV fluid drip, and premedication with 0.02-0.03 mg/kg intravenous midazolam will be done. All basic monitoring will be applied (ECG/HR/SpO2/NIBP), and baseline values for HR, SPO2, SBP, DBP and MAP will be documented then every 5 minutes till the patient reaches the operating room.

In group 1 a mark will be applied on the required level (T10) identified as 3rd spinous process caudal to that of T7 which located in the middle of a line passing between the lower tips of the scapulae, the midline (spinous processes) and the injection points 3 cm on either sides from midline. While the patient is in a sitting position with support from a member of staff, Preparation of the field with iodine will be made. The ultrasound transducer is placed in a longitudinal parasagittal orientation using the HFL38X linear multi-frequency 6-13 MHz probe of SonoSite M-Turbo of portable ultrasound system anatomical landmarks will be identified including the transverse process at T10 level and the layers of muscles from posterior to anterior: trapezius-erector spinae. After subcutaneous lidocaine 2% injection a 22-G spinal needle will be inserted under ultrasound guidance in plane, aiming towards the transverse process. After a Gentle contact with the transverse process, a volume of 20 ml for each side with 0.25% bupivacaine will be injected in increments with careful repetitive aspiration to avoid intravascular injection targeting to cover dermatomal levels from T8-T12 as minimum.

In group 2 while the patient is lying supine, the probe will be placed perpendicular to the mid-axillary line between the iliac crest and subcostal margin, the 3 abdominal muscle layers were identified, and the transversus abdominis plane was located between the internal oblique and transversus abdominis muscle. Next, 20 mL of 0.25% bupivacaine will be injected in increments with careful repetitive aspiration to avoid intravascular injection, and drug spread in the plane will be observed. The same procedure will be repeated on the other side of the abdomen.

Then the patient will be transferred to the OR. All basic monitoring will be applied (ECG/HR/SpO2/NIBP) while monitoring of end-tidal CO2 will be initiated after induction of anesthesia and values will be recorded for HR, SPO2 ,SBP,DBP ,MAP and ETCO2 every 5 minutes till the end of the surgery then for 30 minutes from time of reaching PACU.

General anesthesia will be induced with 2 mg/kg propofol, 1μg/kg fentanyl and 0.5 mg/kg atracurium to facilitate endotracheal intubation. After intubation the lungs will be mechanically ventilated to maintain the ETCO2 35-40 mmHg. Anesthesia will be maintained with isoflurane keeping the ET concentration of isoflurane 1-2% to maintain the BIS value 40-60. Atracurium besylate top-up doses 0.1mg/kg will be given based on the response to train of four ulnar nerve stimulation. Additional fentanyl dose of 0.5 µg/kg IV for maximum of 3 µg/kg will be given if HR and /or BP increased more than 20% from baseline in response to surgical stimulation and the total dose of fentanyl will be recorded.

The patient's pain will be monitored and documented using the Numerical Rating Score (NRS) for pain at times 0,30 minutes, 1, 2, 4, 6, 8, 10, 12, 18 and 24 hours.(28)The "zero" point of time will be the moment the patient recovered from general anesthesia. Time to first analgesic requirement will be recorded which is the time from the "zero" point till the NRS is 4 or more.

1 g paracetamol IV will be given every 6 hours regardless the NRS value while rescue medication in the form of 50 mg tramadol IV will be given on demand when NRS score is 4 or more with maximum dose of 1 mg /kg every 6 hours and the total consumption of tramadol will be recorded.

Complications in the form of local anesthetic systemic toxicity, failed block, injury to surrounding structures (peritoneum, vessels, dura ,pleura inform of pneumothorax) will be documented

Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery

A Comparison Between Ultrasound-guided Erector Spinae Plane Block and Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery Under General Anesthesia: Randomized, Controlled Study.

Cairo University

Lecturer of anesthesia

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Adjuvants, Anesthesia

Analgesics

Anti-Inflammatory Agents

Antirheumatic Agents

Fentanyl

Ibuprofen

Anesthetics, Local

Analgesics, Opioid

Narcotics

Anesthetics, Intravenous

Anesthetics, General

In group 30 ml, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 30 ml %0.25 bupivacaine will be administered for block.

In group ESPB, ESPB will be performed with patients in the lateral decubitus position while the surgical site up. US probe will be placed 2-3 cm lateral to the T4 transvers process. The block needle will be inserted cranio-caudal direction and then for correction of the needle 5 ml saline will be injected deep into the erector spina muscle fascia. Following confirmation of the correct position of the needle 20 ml %0.25 bupivacaine will be administered for block.

Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit. Postoperative patient evaluation will be performed by an anesthesiologist blinded to the procedure.

Bupivacaine + Fentanyl

Postoperative pain is an important issue in female patients underwent breast surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided erector spina plane block (ESPB) may be used for postoperative pain treatment following breast surgery. It is a relatively novel interfascial block that was defined by Forero et al. It has been reported that ESPB provides effective analgesia management for several breast surgeries.

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice.

The US-guided erector spina plane block (ESPB) provides thoracic analgesia at T5 level and abdominal analgesia at T7-9 level. ESPB contains a local anesthetic injection into the deep fascia of erector spinae. Visualization of sonoanatomy is easy, and the spread of local anesthesic agents can be easily seen under the erector spinae muscle. Thus, analgesia occurs in several dermatomes with cephalad-caudad way. In the literature, it has been reported that ESP block provides effective analgesia after several surgeries such as open heart surgery, breast surgery, thoracoscopic and abdominal operations.

The aim of this study is to compare the efficacy of the different volumes of US-guided ESPB for postoperative analgesia after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption, and the secondary aim is to evaluate pain scores (VAS), and adverse effects related with opioids (allergic reaction, nausea, vomiting).

There are two models for this study. The first group is 30 ml volume ESPB group. The second one is 20 ml volume ESPB group

The participant and the anesthesiologist who will perform postoperative pain evaluation and opioid consumption will not know the group

Female patients who will undergo breast surgery will be included

Different Volumes of Erector Spinae Plane Block for Breast Surgery

Erector Spinae Plane Block in Different Volumes on Postoperative Pain Control Following Breast Surgery: A Randomized, Prospective Study

The primary aim is to compare postoperative opioid (fentanyl) consumption on patient controlled analgesia device.

The parameters on PCA devices such as delivery and demand will be assessed

Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores will be recorded

Medipol University

Principal Investigator

Fibroadenoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Neoplasms by Histologic Type

Neoplasms, Glandular and Epithelial

In group P, PECS will be performed with patients in the supine position at the end of the surgery before extubation by using US (Vivid Q, GE Healthcare, US). Under aseptic conditions the high frequency linear probe (11-12 MHz) will be covered with a sterile sheath and a 22G, 50 mm block needle will be used. US probe will be placed on the 4th rib. The muscles PMm, Pmm and Sam will be visualized. At the anterior axillary level or mid-axillary level, via the in-plane technique, Pecs II will be applied by injecting 20 mL of 0.25% bupivacaine in a cephalad to caudad direction to the fascia on Sam.

In group R, RIB block will be performed with patients in the lateral decubitus position at the end of the surgery before extubation. The linear high frequency probe will be placed in sagittal plane medially on the medial border of the scapula at T5-6 level. The trapezius muscle, rhomboid major muscle, intercostal muscle, ribs and the pleura will be visualized. The needle will be inserted into the fascial plane between the rhomboid major and intercostal muscles in a cranio-caudal direction. A dose of 20 ml 0,25% bupivacaine will be injectted into the fascial plane.

A dose of ibuprofen 400 mgr and tramodol 100 mg will be performed intraoperatively. Patients will be administered ibuprofen 400 mgr IV every 8 hours in the postoperative period. A patient controlled device prepared with 10 mcg/ ml fentanyl will be attached to all patients with a protocol included 10 mcg bolus without infusion dose, 10 min lockout time and 4 hour limit.

PECS block

Rhomboid intercostal block

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The primary aim of the study is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

Postoperative pain is an important issue in patients underwent mastectomy and axillary dissection surgery. Postoperative effective pain treatment provides early mobilization and shorter hospital stay, thus complications due to hospitalization such as infection and thromboembolism may be reduced.

Various methods may be performed to reduce the use of systemic opioids and for effective pain treatment following mastectomy and axillary dissection surgery. Ultrasound (US)-guided interfascial plane blocks have been used increasingly due to the advantages of ultrasound in anesthesia practice. The US-guided pectoral nerve block (PECS) may be used for postoperative pain treatment following breast surgery. It is a novel interfascial block that was defined by Blanco. It is easy to perform; under ultrasound (US) guidance, the interfascial region between the pectoral muscles (pectoralis major (PMm) and minor (Pmm), serratus anterior Sam) is injected with local anaesthetics. It has been reported that PECS type-2 block provides effective analgesia management for mastectomy and axillary dissection surgeries.

Rhomboid intercostal block (RIB) is a novel block and was first described by Elsharkawy et al. Local anesthetic solution is administrated between the rhomboid muscle and intercostal muscles over the T5-6 ribs 2-3 cm medially of the medial border of the scapula. RIB targets both the posterior rami and lateral cutaneous branches of the thoracic nerves and provides analgesia for the hemithorax from T2 to T9. It has been reported that RIB may provide effective analgesia management for several breast surgeries.

The aim of this study is to evaluate the efficacy of the US-guided PECS-II and RIB for postoperative analgesia management compare to no intervention control group after mastectomy and axillary dissection surgery. The primary aim is to compare postoperative opioid consumption and the secondary aim is to evaluate postoperative pain scores (VAS), adverse effects related with opioids (allergic reaction, nausea, vomiting).

There are three models for this study. Patients will be randomly divided into three groups (Group P = PECS group, Group R = RIB group, Group C = Control group), before entering the operating room.

The anesthesiologist who performs postoperative pain evaluation will not know the group.

Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

Comparison of Ultrasound-Guided Type-II Pectoral Nerve Block and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery

The primary aim is to compare postoperative opioid consumption

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery	NCT04434339	Postoperative P...	erector spinae ... transversus abd...	18 Years - 65 Years	Cairo University
Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery	NCT04434339	Postoperative P...	erector spinae ... transversus abd...	18 Years - 65 Years	Cairo University
Ultrasound-guided Erector Spinae Plane Block Versus Transversus Abdominis Plane Block for Postoperative Analgesia of Adult Patients Undergoing Ovarian Cancer Surgery	NCT04434339	Postoperative P...	erector spinae ... transversus abd...	18 Years - 65 Years	Cairo University
Different Volumes of Erector Spinae Plane Block for Breast Surgery	NCT05232084	Breast Cancer Breast Neoplasm... Breast Diseases	Bupivacaine + F...	18 Years - 65 Years	Medipol University
Pectoral Nerve Block Type-II and Rhomboid Intercostal Block for Pain Management Following Mastectomy Surgery	NCT04297007	Breast Cancer Breast Neoplasm... Breast Diseases Breast Fibroade...	PECS block Rhomboid interc...	18 Years - 65 Years	Medipol University

Spots Global Cancer Trial Database for postoperative pain management