A Phase 3 interventional study of Ropivacaine after dilution with sodium chloride 0.9% in Ambulatory Plastic Surgery and Esthetic Prosthetic Breast Expansion, sponsored by University Hospital, Montpellier. Completed at 3 sites in France. Open to female participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2026-06-12.
Sponsored by University Hospital, Montpellier · Phase 3, Interventional, and Treatment
Breast augmentation is among the most popular surgical procedures performed in the world with approximately 1,773,584 performed in 2013. This surgical intervention generates important pains during postsurgical recovery. A multimodal analgesia, based on the recommendations is proposed to the patients .The pectoral nerve block is an innovative technique of locoregional anesthesia that has already been successfully used in breast surgery. Its realization is fast, simple, and it would be superior compared with a paravertebral block within the framework of mastectomy. The interest of this technique has never been assessed in esthetic breast surgery. The aim of this study is to evaluate the analgesic efficacy of the association of " Pecs blocks 1 and 2 " on pain intensity after breast augmentation surgery.
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.
2,219 studies on the registry are indexed under Pain; 917 are open to participants now.
This study's enrollment of 74 is close to the median of 70 across 1,904 interventional studies indexed under Pain.
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Exclusion Criteria:
The PECS Blocks are not (1) performed.
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
Value of pain according to a Numeric scale , recorded at day 1 in the hospital, and until day five by phone interview.
Time frame: Five days
Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire
Any of side effect
Time frame: Five days
Plan to share: Undecided
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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University Hospital, Montpellier