Pain, Postoperative
Conditions
Keywords
PECS block,, pectoral block,, breast augmentation
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.
Interventions
DRUGRopivacaine (PECS bloc)
Ropivacaine 3.75mg/mL Injection of a local anesthetic between pectoral major and pectoral minor muscles
DRUGPlacebo
20 mL saline 0.9%
Sponsors
University Hospital, Lille
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| First administration of morphine | During the first 24 postoperative hours | Time elapsed between tracheal extubation and first administration of morphine |
| 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 |
| 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 |
Countries
France
Outcome results
None listed