Symptoms and General Pathology

All Conditions

Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Nervous System Diseases

Pain, Postoperative

Prostatic Neoplasms

Pain

Postoperative Complications

Neurologic Manifestations

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Central Nervous System Depressants

All Drugs and Chemicals

Bupivacaine

Anesthetics

Anesthetics, Local

Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.125%

Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.125%

0.2 ml/kg bupivicaine 0.125% injected bilateraly at the posterior border of the quadratus Lumborum muscle

Quadratus Lumborum block

0.2 ml/kg bupivicaine 0.125% injected bilateraly between internal oblique and transversus abdominis muscles.

Tranversus Abdominis plane block

Tomasz Skladzien, MD PHD

Recently, the uses of peripheral axial blocks that deliver local anesthetic into the transversus abdominis fascial plane have become popular for operations that involve incision(s) of the abdominal wall. Thus, the Transversus Abdominis plane (TAP) block has been shown to reduce perioperative opioid use in elective abdominal surgery, including open appendicectomy, laparotomy, and laparoscopic cholecystectomy.

Currently, the Quadratus Lumborum block (QL block) is performed as one of the perioperative pain management procedures for all generations (pediatrics, pregnant, and adult) undergoing abdominal surgery. The local anesthetic injected via the approach of the posterior QL block ( QL 2 block ) can more easily extend beyond the TAP to the thoracic paravertebral space or the thoracolumbar plane, the posterior QL block entails a broader sensory-level analgesic and may generate analgesia from T7 to L1. Use of posterior QL block in laparoscopic prostatectomy has not been investigated before and it is the variant that will be discussed in our study.

In laparoscopic prostatectomy, overall pain is a conglomerate of three different and clinically separate components: incisional pain (somatic pain), visceral pain (deep intra abdominal pain), and shoulder pain due to peritoneal stretching and diaphragmatic irritation associated with carbon dioxide insufflation. Moreover, it has been hypothesized that intense acute pain after laparoscopic prostatectomy may predict development of chronic pain. Without effective treatment, this ongoing pain may delay recovery, mandate inpatient admission, and thereby increase the cost of such care.

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia

Total cumulative oxycodone dose in mg used in the first 24 hours after surgery

VAS range from 0 for no pain to 10 for worst pain imaginable

Jagiellonian University

MD PHD

Skin and Connective Tissue Diseases

Breast Neoplasms

Adjuvants, Anesthesia

Analgesics

Antipyretics

Anti-Inflammatory Agents

Antitussive Agents

Respiratory System Agents

Fentanyl

Oxycodone

Acetaminophen

Ropivacaine

Morphine

Hydromorphone

Analgesics, Opioid

Anesthetics, General

Codeine

Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Ultrasound-guided erector spinae plane block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Paravertebral block

Ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Erector spinae plane block

General anesthesia administered as per preference of intra-operative attending anesthesiologist

General anesthetic

Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone. Post-operatively in post anesthesia care unit, morphine and hydromorphone will be titrated to effect as necessary. After discharge from post anesthesia care unit, oral analgesia will be administered on an as required basis e.g. acetaminophen, non-steroid anti-inflammatory medications, acetaminophen / codeine and acetaminophen / oxycodone.

Opioids

Weight-based dosing of this local anesthetic mixture.

This study aims to compare the effectiveness of paravertebral block and erector spinae plane block after mastectomy.

The primary objective of this randomized controlled trial is to demonstrate equivalent dermatomal spread for ultrasound-guided single-injection Erector Spinae Plane (ESP) block performed at T4-T5 level and ultrasound-guided single-injection (paravertebral) PVB block at the same level.

Secondary objectives are Numerical Rating Scale (NRS) pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion.

The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform with less associated discomfort during block insertion.

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgery. Advantages of a PVB technique include reduced postoperative pain, analgesic consumption, opioid-related side effects, and shorter post anesthesia care unit (PACU) stay. There is also evidence to suggest that PVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura. Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. Radiological imaging in a cadaver model has demonstrated that a single injection at the level of the T5 transverse process produced cranio-caudal spread between C7 and T8. This accounts for the extensive sensory block that has been observed in case reports and is at least as extensive as the spread seen with PVB.

ESP is a more superficial block with a better defined end-point - injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. Furthermore, ESP does not have the same risk of pneumothorax as PVB.There have been no randomized controlled trials involving ESP to date. All descriptions of the technique have been in case report / series format.

The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform, has less associated discomfort and fewer complication risks.

All eligible participants will be randomized to the PVB arm or the ESP arm after fully informed consent has been obtained. Subjects randomized to the PVB arm will have an ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Subjects randomized to the ESP arm will have an ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Conduct of intra-operative anesthesia will be at the discretion of the attending anesthesiologist.

The primary outcome is equivalent dermatomal spread for ultrasound-guided single-injection ESP block performed at T4-T5 level and ultrasound-guided single-injection PVB block at the same level.

Secondary outcomes are NRS pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion.

The primary outcome will be collected by a research associate who is blinded to the study group allocation. The secondary outcomes will be collected by the study team from the patient chart and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test. Markers of intervention safety will be monitored included local anesthetic toxicity, nerve injury, infection and pneumothorax.

A test of equivalence will be performed for the primary outcome of dermatomal spread between the 2 groups. If the equivalence is not established for the block extent, a 2-way superiority will be conducted. Secondary outcomes will be analyzed using Mann-Whitney U test and the Hodges-Lehmann method for calculating 95% confidence intervals (CIs) around the median difference. Assuming a median difference of 1.5 dermatomal segments, and a pooled standard deviation (SD) of 1.65 segments, α of 0.05, and 90% power, a total sample size of 42 patients is estimated (21 patients in each group).

Erector Spinae Plane Block Versus Paravertebral Block

Erector Spinae Plane Block Versus Paravertebral Block in Patients Undergoing Elective Breast Surgery. A Randomized Controlled Trial Comparing Dermatomal Spread.

Assessment of extent of sensory block by pinprick

Subjective pain score between 0 (no pain) and 10 (worst possible pain) immediately post-operatively at 6, 12 and 24 hours

Amount of opioid administered by the intra-operative anesthesiologist

Amount of opioid used by patient in the first 24 hours after surgery

Amount of time it takes to perform the block procedure starting with when the ultrasound image is acquired and finishing when all of the local anesthetic has been injected

University of Alberta

Mouth and Tooth Diseases

Digestive System Diseases

Stomatitis

Mucositis

Gastroenteritis

Gastrointestinal Diseases

Mouth Diseases

Stomatognathic Diseases

Anti-Arrhythmia Agents

Channel Blockers

Pharmaceutical Solutions

Anticonvulsants

Psychotropic Drugs

Lidocaine

Gabapentin

Sodium Channel Blockers

Diuretics, Potassium Sparing

Narcotics

Analgesics, Non-Narcotic

Anti-Anxiety Agents

Excitatory Amino Acid Antagonists

Neurotransmitter Agents

The patients can take up to eight 25 mg bupivacaine lozenges (max. every second hour in the awake hours) a day for seven days. The patients can use concomitant systemic pain treatment (e.g. morphine).

The patients will be treated with the currently used standard pain treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin). The anesthetics are being administered at the physician's discretion.

Standard treatment includes lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin

Standard treatment (lidocaine viscous solution, morphine, paracetamol, NSAID, gabapentin)

Claus A Kristensen, MD, PhD

Jens Bentzen, MD

Oral mucositis is a damage to the mucosa of the oral cavity and pharynx. It is a serious and painful adverse effect caused by the radio therapy and/or chemo therapy patients with head and neck cancer receive. The pain caused by oral mucositis can be difficult to treat as the current treatment with opioids is not sufficient and can cause adverse effects.

Our hypothesis is that treatment with a local anesthetic lozenge with bupivacaine can reduce the oral pain caused by mucositis compared with the current standard treatment.

Local Anesthetic Treatment of Oral Pain in Patients With Mucositis

Clinical Trial With Lozenges as Local Anesthetic Treatment for Head/Neck Cancer Patients With Oral Mucositis

The primary outcome measure is the mean VAS score for the patients in the bupivacaine lozenge group compared with the mean VAS score for the patients in the standard treatment group.

The lozenge group measures VAS before and 60 min. after administration of a lozenge for seven days. The standard treatment group measures VAS every second hour for seven days.

Mean value of the pain score (VAS) measured 120 minuts after the administration of a lozenge for the patients receiving the lozenges compared with the mean value of the pain score (VAS) measured every second hour for the patients receiving the standard treatment.

The difference in pain score (VAS) between the first score in the morning before the first lozenge of the day and the score 60 minuts after the administration of the lozenge. Pain is scored both in the oral cavity and the pharynx.

The first ten patients receiving the bupivacaine lozenge will on day seven (the last day of their treatment period) get blood samples drawn before a lozenge is administrated and at time 30 min, 60 min. and 90 min. after the administration.

Moberg Pharma, Sweden

Hvidovre University Hospital

MD, PhD

Neuralgia

Breast Diseases

Skin Diseases

Patients with persistent pain after breast cancer surgery receive the ultrasound guided PECS block of 20mls 0.25% bupivacaine

16 patients awaiting surgery for breast cancer were scanned using ultrasound to determine the sonoanatomy of the PECS block

Ultrasound guided delivery of local anesthetic between the pectoral muscles

PECS block

Nelun Wijayasinghe, MBBS, BSc

Kenneth G Andersen, MD, PhD

Henrik Kehlet, MD, PhD, DMsc

This is a pilot study of the pectoral nerves block (PECS) in patients with persistent pain after breast cancer surgery.

This study is in 2 parts: Part 1 is a description of the anatomy of the PECS block in pain free, unoperated patients using ultrasonography (non invasive). Part 2 is the administration of the block to patients that have persistent pain after breast cancer surgery. Before and after the block we will take a detailed pain history and do neurophysiological tests called quantitative sensory testing (QST). These tests assess the patients' ability to feel warmth, cold and test their thresholds for pain. The block is then administered using ultrasound guidance and 20mls of 0.25% bupivacaine is injected in the pectoral muscles on the side with pain. Thirty minutes after the block, the pain is re assessed and the QST is repeated.

Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery

Ultrasound Guided Pectoral Nerves (Pecs) Blockade in Persistent Pain After Breast Cancer Surgery

Patients will complete a pain diary for 5 consecutive days before administration of the PECS block and 7 consecutive days after the block. The patients also complete a functional questionnaire the day before the block and again exactly one week after the block.

SPI is a combination of pain at rest + pain on arm abduction + pain with 100kPa pressure. SPI will be taken before and 30 minutes after the PECS block

QST consists of sensory mapping (delineating areas of hypo/hyperesthesia and/or allodynia), warm detection thresholds, cool detection thresholds, heat pain thresholds, suprathermal heat pain response and pressure pain thresholds. These will be measured before and 30 minutes after the PECS block

Kehlet, Henrik, M.D., Ph.D.

Rigshospitalet, Denmark

Anesthesiologist, clinical researcher

Ropivacaine is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Ropivacaine would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Ropivacaine (1mg/mL) would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.

Saline is instillated through one multi-hole catheter wich would be inserted percutaneously in all patients and tunnelled about 1-2 cm lateral to the abdominal incision and the tip of the catheter placed in the intra-peritoneal cavity. The catheter would not be ligated and fixed in situ intra-peritoneally. Twenty ml of Saline would be injected subcutaneously along both sides of the incision prior to skin closure. Additionally, 20 ml of Saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen.

Saline

Sven-Egron Thorn, MD PhD

Anil Gupta, MD PhD

Sven-Erik Ricksten, MD PhD

Can perioperative administration of intra-peritoneal local anaesthetics further reduce postoperative pain, inflammation and outcome in patients undergoing major abdominal surgery (cytoreductive surgery) and managed with thoracic epidural analgesia? - Multicenter study.

The aim of this study is to measure the efficacy of local anesthetics (LA) administered into the intra-peritoneal cavity compared to placebo. Our hypothesis is that the injection of local LAs intra-peritoneally would reduce post-operative pain and the inflammatory process caused by the massive release of cytokines during extensive cytoreductive surgery. The study is a controlled, parallel group, double blind, prospective, randomized and performed at Sahlgrenska University Hospital in Goteborg, Sweden . Twenty mL of ropivacaine or saline would be injected every hour by an automatic pump via the intra-peritoneal catheter into the abdomen according to group randomization in order to double blind patients and all personnel involved in the study.

The parameters that would be evaluated are inflammatory markers, postoperative morbidity, pain intensity, consumption of morphine, cognitive function and progression-free survival.

Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery

Peroperative Analgesia Following Cytoreductive Surgery. A Randomized, Double-blind, Comparison Between Intra-peritoneal Local Anesthesia and Placebo - Multicenter Study

Analysis of the following inflammatory markers with Multiplex: IL(interleukin)-1β, IL-1rα, IL-2, IL-4, IL-5, IL-6, IL-7, IL-8, IL-9, IL-10, IL-12 (p70), IL-13, IL-15, IL-17A, zBasic FGF (Fibroblast Growth Factor), Eotaxin, G-CSF (granulocyte colony stimulating factor), GM-CSF granulocyte macrophage colony stimulating factor), IFN-γ (interferon), IP-10 (immune protein), MCP-1 (monocyte chemotactic protein), MCAF (monocyte chemotactic and activating factor), MIP-1α (macrophage inflammatory protein), MIP-1β, PDGF-BB (platelet-derived growth factor), RANTES (regulated on activation, normal T cell expressed and secreted), TNF-α (tumor necrosis factor), VEGF (vascular endothelial growth factor)

Total amount of Morphine consumed during the first 48 hours after surgery

Pain Intensity is measured with Numeric Rating Score 0-10

Patients will complete the following neurophysiological tests upon entering the study and within one month after surgery: Verbal Learning Test (VLT), Concept Shifting Test (CST), Letter-Digit Coding, Verbal Learning Test - Delayed Recall (VLT-D)

Progression-free Survival measures the length of time after treatment during which the cancer being treated does not get worse.

Measuring the numbers of Postoperative Morbidity/Complications within one month after surgery:

Morbidity:

* Local infections
* Urinary infection (urine culture)
* Pneumonia (X-ray, C-reactive protein, Fever)
* Sepsis (Fever, Leucocyte count in blood, Heart Rate, Respiratory Rate)
* Pleural fluid (X-ray verified)
* Deep Vein Thrombosis (D-dimer, ultrasound verified)
* Pulmonary embolism (Computed Tomography/ Scint-X)
* Acute Myocardial Infarction (Electrocardiography, Troponin I)
* Atrial fibrillation or serious arrhythmia during the first 48 hours after surgery (Electrocardiography)
* Respiratory failure (prolonged mechanical ventilation)
* Renal failure (Serum Creatinine, Diuresis, AKIN criteria)
* Inotropic needs \> 12 hours after surgery

Surgical Complications:

* Intraabdominal bleeding
* Leakage from anastomosis
* Abdominal abscess
* Paralytic ileus
* Pancreatic leakage (requiring drainage)

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia	NCT03606889	Prostatic Cance... Pain, Postopera... Pain Anesthetics, Lo...	Quadratus Lumbo... Tranversus Abdo... Bupivacaine	18 Years - 90 Years	Jagiellonian University
Erector Spinae Plane Block Versus Paravertebral Block	NCT03471442	Breast Cancer Pain, Postopera... Anesthesia, Loc...	Paravertebral b... Erector spinae ... General anesthe... Opioids Anesthetics, Lo...	18 Years -	University of Alberta
Erector Spinae Plane Block Versus Paravertebral Block	NCT03471442	Breast Cancer Pain, Postopera... Anesthesia, Loc...	Paravertebral b... Erector spinae ... General anesthe... Opioids Anesthetics, Lo...	18 Years -	University of Alberta
Local Anesthetic Treatment of Oral Pain in Patients With Mucositis	NCT02252926	Mucositis	Bupivacaine Standard treatm...	18 Years - 80 Years	Hvidovre University Hospital
Ultrasound Guided Pectoral Nerves Blockade for Persistent Pain After Breast Cancer Surgery	NCT02349581	Persistent Pain...	PECS block Bupivacaine	18 Years -	Rigshospitalet, Denmark
Quadratus Lumborum Block vs Transversus Abdominis Plane Block for Post-prostatectomy Analgesia	NCT03606889	Prostatic Cance... Pain, Postopera... Pain Anesthetics, Lo...	Quadratus Lumbo... Tranversus Abdo... Bupivacaine	18 Years - 90 Years	Jagiellonian University
Intra-Peritoneal Local Anaesthesia After Cytoreductive Surgery	NCT02256228	Pain	Ropivacaine Saline	18 Years - 74 Years	Göteborg University

Spots Global Cancer Trial Database for anesthetics, local