PECS I Block for Breast Subpectoral Implant Surgery

NCT02849236 | Completed

• 2 other identifiers: 2015_172016-000157-12
• Study Type: interventional
• Target: 56
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative

Keywords

PECS block,; pectoral block,; breast augmentation

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (8)

• First administration of morphine

  During the first 24 postoperative hours

• Post-operative nausea and/or vomiting

  During the first 24 postoperative hours

• Intra-operative opioids consumption

  During procedure execution

• Post-operative anti-emetic consumption

  During the first 24 postoperative hours

• Post-operative pain

  During the first 24 postoperative hours

Study Arms (2)

Control group

PLACEBO COMPARATOR

PECS block performed with Saline solution instead of local anesthetic

Drug: Placebo

PECS group

EXPERIMENTAL

PECS block performed with Ropivacaine 3.75mg/mL

Drug: Ropivacaine (PECS bloc)

Interventions

Ropivacaine (PECS bloc) DRUG

Ropivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles

Also known as: ropivacaine

PECS group

Placebo DRUG

20 mL saline 0.9%

Also known as: saline

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Every female who will benefit of a bilateral subpectoral breast augmentation
• Age more than 18 years
• Social insured

You may not qualify if:

• 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)

Sponsors & Collaborators

• University Hospital, Lille: lead

Study Sites (1)

Hôpital Roger Salengro, CHU de Lille

Lille, France

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Ropivacaine; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Benoit Tavernier, MD, PhD

  University Hospital, Lille

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 19, 2016
• First Posted: July 29, 2016
• Study Start: October 16, 2016
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: August 26, 2020

Record last verified: 2020-08

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)