PECS I Block for Breast Subpectoral Implant Surgery
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| 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:
|
| 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:
|
Outcome Measures
Primary Outcome Measures
- 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
- 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
- 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
- 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
- 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.
- Time physiological function recovery [During the first six postoperative hours after tracheal extubation]
Ability to drink, to eat, to urinate, to walk
Eligibility Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Hôpital Roger Salengro, CHU de Lille | Lille | France |
Sponsors and Collaborators
- University Hospital, Lille
Investigators
- Principal Investigator: Benoit Tavernier, MD, PhD, University Hospital, Lille
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 2015_17
- 2016-000157-12