Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Nervous System Diseases

Rare Diseases

Breast Neoplasms

Pain

Acute Pain

Neurologic Manifestations

Acute Graft Versus Host Disease

Central Nervous System Depressants

All Drugs and Chemicals

Adjuvants, Anesthesia

Analgesics

Platelet Aggregation Inhibitors

Antipyretics

Anesthetics

Fentanyl

Oxycodone

Rocuronium

Ropivacaine

Propofol

Sevoflurane

Succinylcholine

Acetaminophen

Analgesics, Non-Narcotic

Analgesics, Opioid

Narcotics

Standard care without regional block. General anesthesia. After the end of the surgery, the patient-controlled analgesia with oxycodone.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.375% ropivacaine will be performed. Then, the patient will be treated as in the controlled group.

After the induction of general anesthesia, before the beginning of the surgery, the erector spinae plane block with 0.9% saline will be performed. Then, the patient will be treated as in the controlled group.

Ultrasound-guided the erector spinae plane block with 0.375% ropivacaine, 0.4 mL per KG, up to 40 mL (maximum dose).

Erector spinae plane block

Ultrasound-guided the erector spinae plane block with 0.9% saline, 0.4 mL per KG, up to 40 mL (maximum dose).

Sham block

Standard general anesthesia. The induction with fentanyl, 1-3 mcg per KG; propofol, 1.5-2 mg per kg. Then, the laryngeal mask airway will be inserted. Patients with the risk of aspiration will be intubated using rocuronium or suxamethonium.

The maintenance with oxygen/air mixture, sevoflurane, and fentanyl.

General anesthesia

All patients will receive a PCA pump with oxycodone (1 mg/mL, 5-minute interval) after transfer to PACU (post-anesthesia care unit)

Patient-controlled analgesia

Intravenous oxycodone will be administered about 30 minutes before the end of the surgery at a dose of 0.1 mg/KG. Additional 2 doses can be given if pain on the visual analog scale will be higher than 40.

intravenous paracetamol will be used (1.0 gram), up to 4 grams per day

paracetamol

Paweł Piwowarczyk, MD-PhD

Patients scheduled for breast surgery due to cancer. Each patient will be treated with intravenous (i.v.) oxycodone - patient-controlled analgesia (PCA). Patients will be allocated to one of three groups: erector spinae plane (ESP) block, sham block, controlled group.

Only patients who are qualified for an elective procedure of mitral breast surgery may participate in the study. Each patient will be anesthetized generally. The same drugs will be used in each stage of anesthesia. The induction: propofol, fentanyl, rocuronium. The airway will be secured with a laryngeal mask airway (LMA). When there is a risk of aspiration, the patient will be intubated. Then, rocuronium or suxamethonium will be used. The anesthesia maintenance: sevoflurane, fentanyl. The emergence: oxygen, sugammadex or neostigmine a required.

After the induction of general anesthesia, an opaque envelope with the selected group will be opened. In the controlled group, the procedure will be continued in the patient's supine position. Women from the ESP and Sham groups will be placed in the lateral position. The operated side will be above. Then, the ultrasound-guided ESP block with saline or ropivacaine will be performed.

At the end of the surgery, an anesthesiologist will administer oxycodone intravenously (0.1 mg/KG).

After emergence from anesthesia, the patient will be transferred to the postoperative care unit. Vital signs will be monitored. The patient-controlled analgesia pump with oxycodone will be used.

The patient: The primary intervention (erector spinae plane block) will be provided under general anesthesia.

The investigator and outcome assessor will be not aware of the allocation.

ESP in Breast Surgery Due to Cancer

Effectiveness of the Erector Spinae Plane Block in Patients Undergoing Breast Surgery Due to Cancer

Quality of recovery (QoR) score containing 40 items. This questionnaire measures the early postoperative health status of patients. Minimum is 40, maximum is 200. More points is better.

Acute pain measured with VAS (visual analog scale). From 0 (no pain) to 100. More on the scale is worse.

Consumption of oxycodone with PCA pump, loading, and additional doses.

Medical University of Lublin

associate professor

Anti-Arrhythmia Agents

Channel Blockers

Sufentanil

Lidocaine

Dsuvia

Paravertebral block with an ultrasound-guided technique; opioid-free general anesthesia

Sham block by local infiltration at the same site of paravertebral block; opioid based general aneshesia

Paravertebral block will be performed at T2,T4 level on the surgical side using out-of-plane approach under ultrasound-guided, with 0.4% ropivacaine 20ml at each injection site.

paravertebral block

propofol, lidocine and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained.

opioid free anesthesia

Local infiltration at the same site of paravertebral block will be performed, with 1% lidocaine 3ml on each injection site.

sham block

propofol, sufentanil and muscle relaxant will be used for induction, after laryngeal mask airway insertion, general anesthesia will be maintained .

opioid general anesthesia

Yi Feng, MD,PhD

A comparison of incidences of postoperative nausea and vomiting (PONV) , postoperative pain severity and recovery parameters in breast cancer patients receiving opioid or opioid-free general anesthesia.

Breast cancer is one of the most common oncologic diagnosis in women. Surgery is traditionally performed under general anesthesia with opioid-based analgesia. It is associated with higher incidences of PONV, more severe acute postoperative pain and increased incidences of chronic pain. The possibility of higher risk of metastasis has also been reported.

The purpose of our study is to compare the opioid-free general anesthesia with the opioid-based general anesthesia with respect to the quality of recovery, postoperative pain and cancer recurrence and metastasis.

Opioid Free Anesthesia in Breast Cancer Surgery

Opioid Free Anesthesia in Breast Cancer Surgery: a Prospective Randomized Study

15-item 15-item 15-item quality of recovery questionnaire

evaluated using EuroQol 5 dimensions questionnaire

Numeric Rating Scale pain scores, pain questionnaires

Peking University People's Hospital

Chief of the Anesthesiology Department

Pain, Postoperative

Postoperative Complications

Levobupivacaine

Female undergone mastectomy and received pectoral nerve block

Female undergone mastectomy and not received pectoral nerve block but have received conventional analgesic methods

The patients were randomised to receive a PECS block consisting of 30 ml of levobupivacaine 0.25% after induction of anaesthesia (PECS group) or a saline mock block (control group). The patients answered a 40-item QoR questionnaire (QoR-40) before and 1 day after breast cancer surgery. MAIN OUTCOME MEASURES

PECs block during mastectomy

Female undergone mastectomy and have received conventional analgesic methods

Khaled Salah, Resident Dr

Mohamed Rizk, Lecturer

Mostafa Alaa eldin, Prof

Impact of pectoral nerve block on postoperative pain and quality of recovery in patients undergoing breast cancer surgery: A prospective study

Breast cancer is the most common malignancy in women; surgery is still the mainstay for the treatment of breast cancer .

Postoperative pain can seriously reduce the quality of patient's life, and acute pain can even trigger chronic pain syndrome. Thoracic paravertebral, thoracic epidural, intercostal nerve, and interscalene brachial plexus blocks have been used for anesthesia and abirritation during mastectomy, but their applications are limited by the complicated technique of the procedures and several complications.

In recent years, there has been increasing interest on a novel, less invasive technique, the pectoral nerve (PECS) block. Numerous clinical trials have focused on the analgesic potential of the pectoral nerve block in breast augmentation surgery, small breast surgery, and breast cancer surgery, and have shown positive results.

Several prospective observational studies in recent years demonstrated that postoperative pain following breast surgery becomes chronic in up to 57% of women.

One of the most important risk factors is insufficiently treated postoperative acute pain. The current gold standard for acute postoperative pain is a preventive procedure-specific multimodal treatment including nonopioids, opioids and regional analgesia.

A recently published Cochran's meta-analysis demonstrated that regional analgesia \[e.g. paravertebral block (PVB), local infiltration\] might even reduce the risk of chronic postsurgical pain after breast surgery. According to a recently published guidelines, pectoral nerves (PECS) blocks seem to be an effective alternative to PVB to manage effectively postsurgical pain in major breast surgery.Anatomical studies revealed a different local anaesthetic spread following injections between the pectoralis major and minor muscles (PECS I) and a combination of the latter injection with a deeper injection between the pectoralis minor and serratus anterior muscles (PECS II) but the results were not conclusive. Many trials have been published and some meta-analyses revealed a high analgesic efficacy following PECS II blocks compared with no block or PVB.

However, one of these meta-analyses was criticised because of methodological problems (e.g. evidence assessment, missing sham block group), pain intensities not analysed separately for resting pain and pain during movement and comparisons with other established or emerging regional anaesthetic techniques (e.g. local infiltration, erector spinae block) were not performed.

Pectoral Nerve Block During Mastectomy

The Effect of Pectoral Nerve Block as a Part of Enhanced Recovery After Mastectomy

The study will be available when the targeted number of cases reached

Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

1. Postoperative pain score on movement Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo)
2. Postoperative pain score at rest Pain score using a verbal numerical scale (0-10) in one breast (bupivacaine) compared to the other breast (placebo).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
ESP in Breast Surgery Due to Cancer	NCT04726878	Breast Cancer Pain, Acute Anesthesia, Loc...	Erector spinae ... Sham block General anesthe... Patient-control... Oxycodone paracetamol	18 Years - 80 Years	Medical University of Lublin
Opioid Free Anesthesia in Breast Cancer Surgery	NCT04390698	Opioid Free Ane...	paravertebral b... opioid free ane... sham block opioid general ...	20 Years - 75 Years	Peking University People's Hospital
Opioid Free Anesthesia in Breast Cancer Surgery	NCT04390698	Opioid Free Ane...	paravertebral b... opioid free ane... sham block opioid general ...	20 Years - 75 Years	Peking University People's Hospital
Pectoral Nerve Block During Mastectomy	NCT05699902	Breast Cancer F... Pain, Postopera...	PECs block duri... Sham block	18 Years - 75 Years	Assiut University

Spots Global Cancer Trial Database for sham block

Every month we try and update this database with for sham block cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Spots Global Cancer Trial Database for sham block

Every month we try and update this database with for sham block cancer trials from around the world to help patients and their families find trials that might be right for them. We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.

Every month we try and update this database with for sham block cancer trials from around the world to help patients and their families find trials that might be right for them.
We offer this 100% free of charge and do not endorse any of the trials listed here, we hope it helps you or a loved one.