Pectoral Nerve Block for Analgesia After Breast Augmentation (PECS B&BS)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02682186|
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : November 6, 2017
|Condition or disease||Intervention/treatment||Phase|
|Ambulatory Plastic Surgery Esthetic Prosthetic Breast Expansion||Drug: Ropivacaine after dilution with sodium chloride 0.9%||Phase 3|
The investigators hypothesized that the "Pecs blocks 1 and 2" will provide a decrease of the maximal pain of the first 6 post-operative hours after prosthetic breast expansion. The pain will be assessed according to a numerical scale. This prospective, randomized, double blind study will include 92 patients successively during two years, randomized into two arms : Pecs group and Control group, which will respectively have the block, and no block. The rest of the anesthesic and surgical care will be identical.
An intervention team (which will be different from the anesthesic team), will be alone with the patient for 15 minutes, and will realize or not the Pecs blocks according to the previous randomisation so that all caregivers taking in charge the patients as well as research observers will be blinded.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||92 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Outcomes Assessor)|
|Official Title:||Effects of the Pectoral Blocks in the Prosthetic Breast Expansion Surgery : Prospective, Randomized, Double Blind Study.|
|Study Start Date :||February 1, 2016|
|Estimated Primary Completion Date :||February 1, 2019|
|Estimated Study Completion Date :||February 6, 2019|
No Intervention: Control group (1)
The PECS Blocks are not (1) performed.
Experimental: PECS group (2)
The PECS Blocks are performed (2): A single injection of Ropivacaine after dilution with sodium chloride 0.9% per fascial plane and per side.
Drug: Ropivacaine after dilution with sodium chloride 0.9%
After the anesthesic induction, the interventional team composed by at least a senior anaesthesiologist and a nurse anesthestic, will survey the patient and perform the Pecs blocks, whereas the anesthetic team is outside the room.
Realization of Pecs blocks 1 and 2 : the patient is in supine position with placing the upper limb in abduction position, a 100 mm needle is inserted under ultrasound using a linear US probe of high frequency after sheathing.
In the other group, sterilization, sheating and US are performed but the needle is not inserted.
- Maximal value of pain intensity according to the numerical scale within the six first hours [ Time Frame: up to First six postoperative hours ]
- Maximal value of the pain at day 1 and until day 5 [ Time Frame: Five days ]Value of pain according to a Numeric scale , recorded at day 1 in the hospital, and until day five by phone interview.
- Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire [ Time Frame: Five days ]Any of side effect
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02682186
|Contact: Gérald GC CHANQUES, MD, PhD||0033.4.67.33.72.71 ext firstname.lastname@example.org|
|Contact: Anne AV VERCHERE||0033.4.67.33.08.12 ext email@example.com|
|UH Montpellier - Hôpital Gui de Chauliac||Recruiting|
|Montpellier, France, 34295|
|Contact: Gérald GC CHANQUES, MD, PhD 0033.4.67.33.72.71 ext 0033 firstname.lastname@example.org|
|Contact: Yassir YA AARAB, Resident 0033621423523 ext 0033 email@example.com|
|Principal Investigator: Anne Françoise AH HOCQUET, MD|
|Principal Investigator: Pierre François PP PERRIGAULT, MS|
|Montpellier, France, 34295|
|Contact: Gérald CHANQUES|
|Nîmes, France, 30029|
|Contact: Philippe CUVILLON, MD PHD CUVILLON philippe <firstname.lastname@example.org>|
|Study Chair:||Gérald GC CHANQUES, MD, PhD||Montpellier University Hospital|