Back to resultsPECS I Block for Breast Subpectoral Implant Surgery
Primary Purpose
Pain, Postoperative
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Ropivacaine (PECS bloc)
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Pain, Postoperative focused on measuring PECS block,, pectoral block,, breast augmentation
Eligibility Criteria
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)
Sites / Locations
- Hôpital Roger Salengro, CHU de Lille
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Experimental
Arm Label
Control group
PECS group
Arm Description
PECS block performed with Saline solution instead of local anesthetic
PECS block performed with Ropivacaine 3.75mg/mL
Outcomes
Primary Outcome Measures
Morphine consumption
Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.
Secondary Outcome Measures
First administration of morphine
Time elapsed between tracheal extubation and first administration of morphine
Post-operative nausea and/or vomiting
Number of nausea and/or vomiting episodes in the twenty-four hours after surgery
Intra-operative opioids consumption
Sufentanil consumption during anesthesia
Post-operative anti-emetic consumption
Consumption of anti-emetic drugs after surgery
Post-operative pain
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
using WHO Sedation scale
- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
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.
Time physiological function recovery
Ability to drink, to eat, to urinate, to walk
Full Information
NCT ID
NCT02849236
First Posted
July 19, 2016
Last Updated
August 24, 2020
Sponsor
University Hospital, Lille
1. Study Identification
Unique Protocol Identification Number
NCT02849236
Brief Title
PECS I Block for Breast Subpectoral Implant Surgery
Official Title
Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
Study Type
Interventional
2. Study Status
Record Verification Date
August 2020
Overall Recruitment Status
Completed
Study Start Date
October 16, 2016 (Actual)
Primary Completion Date
July 2020 (Actual)
Study Completion Date
July 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Lille
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative
Keywords
PECS block,, pectoral block,, breast augmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Placebo Comparator
Arm Description
PECS block performed with Saline solution instead of local anesthetic
Arm Title
PECS group
Arm Type
Experimental
Arm Description
PECS block performed with Ropivacaine 3.75mg/mL
Intervention Type
Drug
Intervention Name(s)
Ropivacaine (PECS bloc)
Other Intervention Name(s)
ropivacaine
Intervention Description
Ropivacaine 3.75mg/mL
Injection of a local anesthetic between pectoral major and pectoral minor muscles
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
saline
Intervention Description
20 mL saline 0.9%
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Morphine consumption by use of patient control analgesia within the first twenty-four hours after surgery.
Time Frame
During the first 24 postoperative hours
Secondary Outcome Measure Information:
Title
First administration of morphine
Description
Time elapsed between tracheal extubation and first administration of morphine
Time Frame
During the first 24 postoperative hours
Title
Post-operative nausea and/or vomiting
Description
Number of nausea and/or vomiting episodes in the twenty-four hours after surgery
Time Frame
During the first 24 postoperative hours
Title
Intra-operative opioids consumption
Description
Sufentanil consumption during anesthesia
Time Frame
During procedure execution
Title
Post-operative anti-emetic consumption
Description
Consumption of anti-emetic drugs after surgery
Time Frame
During the first 24 postoperative hours
Title
Post-operative pain
Description
Evaluation of post-operative pain with a digital scale from 0 to 10 in the first twenty four hours after surgery
Time Frame
During the first 24 postoperative hours
Title
4-point sedation scale
Description
using WHO Sedation scale
- 0 = awake and alert /- 1 = quietly awake / - 2 = asleep but easily roused / - 3 = deep sleep
Time Frame
During the first two postoperative hours
Title
Aldrete score
Description
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.
Time Frame
During the first two postoperative hours
Title
Time physiological function recovery
Description
Ability to drink, to eat, to urinate, to walk
Time Frame
During the first six postoperative hours after tracheal extubation
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoit Tavernier, MD, PhD
Organizational Affiliation
University Hospital, Lille
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital Roger Salengro, CHU de Lille
City
Lille
Country
France
12. IPD Sharing Statement
Plan to Share IPD
No
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PECS I Block for Breast Subpectoral Implant Surgery
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