PECS I Block for Breast Subpectoral Implant Surgery

Pain, Postoperative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02849236
• Other study ID #: 2015_17
• Secondary ID: 2016-000157-12
• Status: Completed
• Phase: N/A
• Start date: October 16, 2016
• Est. completion date: July 2020

Study information

• Verified date: August 2020
• Source: University Hospital, Lille
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2020
• Est. primary completion date: July 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Pain, Postoperative

Intervention

Drug:
• Ropivacaine (PECS bloc)
Ropivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles
• Placebo
20 mL saline 0.9%

Locations

Country	Name	City	State
France	Hôpital Roger Salengro, CHU de Lille	Lille

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Lille

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	First administration of morphine	Time elapsed between tracheal extubation and first administration of morphine	During the first 24 postoperative hours
Secondary	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
Secondary	Intra-operative opioids consumption	Sufentanil consumption during anesthesia	During procedure execution
Secondary	Post-operative anti-emetic consumption	Consumption of anti-emetic drugs after surgery	During the first 24 postoperative hours
Secondary	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
Secondary	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
Secondary	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
Secondary	Time physiological function recovery	Ability to drink, to eat, to urinate, to walk	During the first six postoperative hours after tracheal extubation