PECS I Block for Breast Subpectoral Implant Surgery

Study Overview
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Brief Summary
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Breast augmentation surgery can cause important postoperative pain, especially when bilateral subpectoral implants are used. The investigators hypothesized that a technique of regional analgesia, the pectoral nerve block type I (or PECS I block) would reduce pain within the first twenty-four hours and, in turn, morphine consumption and associated side effects. This is a randomized, controlled, double-blind study which compares intra and postoperative analgesia with or without PECS I block in breast surgery.

Official Title
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Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study

Conditions
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Pain, Postoperative

Intervention / Treatment
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* Drug: Ropivacaine (PECS bloc)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Every female who will benefit of a bilateral subpectoral breast augmentation Age more than 18 years Social insured Exclusion Criteria: refusal of the patient Age less than 18 years Inability to consent History of thoracic surgery or breast implants Pregnancy Inability to use a patient controlled analgesia Contraindication of the use of opioids or local anesthetics Pathology of hemostasis, infection Can not use a PCA Patients under long-term opioids (WHO pain ladder 2 and 3) Patient presenting neuropathic pain during the preoperative period (score greater than or equal to 4 to the DN4 questionnaire, or taking anti-epileptic or antidepressant treatments for neuropathic pain)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Control group<br>PECS block performed with Saline solution instead of local anesthetic | Drug: Placebo<br>* 20 mL saline 0.9%<br>* Other names: saline;|
| Experimental: PECS group<br>PECS block performed with Ropivacaine 3.75mg/mL | Drug: Ropivacaine (PECS bloc)<br>* Ropivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles<br>* Other names: ropivacaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Morphine consumption | Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery. | During the first 24 postoperative hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| First administration of morphine | Time elapsed between tracheal extubation and first administration of morphine | During the first 24 postoperative hours | 
| Post-operative nausea and/or vomiting | Number of nausea and/or vomiting episodes in the twenty-four hours after surgery | During the first 24 postoperative hours | 
| Intra-operative opioids consumption | Sufentanil consumption during anesthesia | During procedure execution | 
| Post-operative anti-emetic consumption | Consumption of anti-emetic drugs after surgery | During the first 24 postoperative hours | 
| Post-operative pain | Evaluation of post-operative pain with a digital scale from 0 to 10 in the first twenty four hours after surgery | During the first 24 postoperative hours | 
| 4-point sedation scale | using WHO Sedation scale - 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep | During the first two postoperative hours | 
| Aldrete score | Aldrete Score is a medical scoring system for the measurement of recovery after anesthesia (post anesthesia) which includes activity, respiration, consciousness, blood circulation and color. | During the first two postoperative hours | 
| Time physiological function recovery | Ability to drink, to eat, to urinate, to walk | During the first six postoperative hours after tracheal extubation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PECS block,, pectoral block,, breast augmentation