PECS I Block for Breast Subpectoral Implant Surgery

Not Applicable

Completed

• Conditions: Pain, Postoperative
• Interventions: Drug: Placebo; Drug: Ropivacaine (PECS bloc)

• Registration Number: NCT02849236
• Lead Sponsor: University Hospital, Lille

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-07-19
• Study First Submitted QC: 2016-07-26
• Study First Posted: 2016-07-29
• Study Start: 2016-10-16
• Primary Completion: 2020-07
• Study Completion: 2020-07
• Status Verified: 2020-08
• Last Update Submitted: 2020-08-24
• Last Update Posted: 2020-08-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 56

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Placebo	PECS block performed with Saline solution instead of local anesthetic
PECS group	Ropivacaine (PECS bloc)	PECS block performed with Ropivacaine 3.75mg/mL

Primary Outcome Measures

Name	Time	Method
Morphine consumption	During the first 24 postoperative hours	Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.

Secondary Outcome Measures

Name	Time	Method
Aldrete score	During the first two postoperative hours	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.
First administration of morphine	During the first 24 postoperative hours	Time elapsed between tracheal extubation and first administration of morphine
Post-operative nausea and/or vomiting	During the first 24 postoperative hours	Number of nausea and/or vomiting episodes in the twenty-four hours after surgery
Post-operative pain	During the first 24 postoperative hours	Evaluation of post-operative pain with a digital scale from 0 to 10 in the first twenty four hours after surgery
4-point sedation scale	During the first two postoperative hours	using WHO Sedation scale; - 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
Intra-operative opioids consumption	During procedure execution	Sufentanil consumption during anesthesia
Post-operative anti-emetic consumption	During the first 24 postoperative hours	Consumption of anti-emetic drugs after surgery
Time physiological function recovery	During the first six postoperative hours after tracheal extubation	Ability to drink, to eat, to urinate, to walk

Trial Locations

Locations (1)

Hôpital Roger Salengro, CHU de Lille; 🇫🇷 Lille, France