PECS I Block for Breast Subpectoral Implant Surgery

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

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.

Study Overview

• Status: Completed
• Conditions: Pain, Postoperative
• Intervention / Treatment: Drug: Placebo; Drug: Ropivacaine (PECS bloc)

• Study Type: Interventional
• Enrollment (Actual): 56
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Lille, France
    • Hôpital Roger Salengro, CHU de Lille

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: University Hospital, Lille

Study record dates

Study Major Dates

• Study Start (Actual): October 16, 2016
• Primary Completion (Actual): July 1, 2020
• Study Completion (Actual): July 1, 2020

Study Registration Dates

• First Submitted: July 19, 2016
• First Submitted That Met QC Criteria: July 26, 2016
• First Posted (Estimate): July 29, 2016

Study Record Updates

• Last Update Posted (Actual): August 26, 2020
• Last Update Submitted That Met QC Criteria: August 24, 2020
• Last Verified: August 1, 2020

More Information

Terms related to this study

• Keywords: breast augmentation; PECS block,; pectoral block,
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anesthetics, Local; Ropivacaine
• Other Study ID Numbers: 2015_17; 2016-000157-12 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO