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Pectoral Nerve Block for Analgesia After Breast Augmentation (PECS B&BS)

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ClinicalTrials.gov Identifier: NCT02682186
Recruitment Status : Recruiting
First Posted : February 15, 2016
Last Update Posted : November 6, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Montpellier

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Ambulatory Plastic Surgery Esthetic Prosthetic Breast Expansion Drug: Ropivacaine after dilution with sodium chloride 0.9% Phase 3

Detailed Description:

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.





Primary Outcome Measures :
  1. Maximal value of pain intensity according to the numerical scale within the six first hours [ Time Frame: up to First six postoperative hours ]

Secondary Outcome Measures :
  1. 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.

  2. Morphinics side effects such as nausea / vomiting, constipation, pruritus; analgesic consumption, surgical complication, satisfaction questionaire [ Time Frame: Five days ]
    Any of side effect



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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Affiliated to a national insurance scheme
  • Having signed the informed consent for this study
  • Score of American Society of Anesthesiology ( ASA) 1-3
  • Be hospitalized in the ambulatory care unit (UCA) or plastic surgery service for a scheduled esthetic prosthetic breast expansion surgery.

Exclusion Criteria:

  • Protected minor or major patients or in the incapacity to give his consent according to the article L1121-8 of the Code of the Health Public.
  • Pregnant or breast-feeding women according to French law.
  • Vulnerable people.
  • Patients participating in another research
  • Allergy with local anesthetics.
  • Severe coagulopathy.
  • Chronic painful Patients (long-term treatment by analgesics)
  • Contraindication to use analgesics of the protocol.
  • Change of breast prostheses

Information from the National Library of Medicine

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


Contacts
Contact: Gérald GC CHANQUES, MD, PhD 0033.4.67.33.72.71 ext 0033 g-chanques@chu-montpellier.fr
Contact: Anne AV VERCHERE 0033.4.67.33.08.12 ext 0033 a-verchere@chu-montpellier.fr

Locations
France
UH Montpellier - Hôpital Gui de Chauliac Recruiting
Montpellier, France, 34295
Contact: Gérald GC CHANQUES, MD, PhD    0033.4.67.33.72.71 ext 0033    g-chanques@chu-montpellier.fr   
Contact: Yassir YA AARAB, Resident    0033621423523 ext 0033    aarabyassir89@gmail.com   
Principal Investigator: Anne Françoise AH HOCQUET, MD         
Principal Investigator: Pierre François PP PERRIGAULT, MS         
UH Montpellier Recruiting
Montpellier, France, 34295
Contact: Gérald CHANQUES         
CHU Nîmes Recruiting
Nîmes, France, 30029
Contact: Philippe CUVILLON, MD PHD       CUVILLON philippe <philippe.cuvillon@chu-nimes.fr>   
Sponsors and Collaborators
University Hospital, Montpellier
Investigators
Study Chair: Gérald GC CHANQUES, MD, PhD Montpellier University Hospital

Responsible Party: University Hospital, Montpellier
ClinicalTrials.gov Identifier: NCT02682186     History of Changes
Other Study ID Numbers: 95832
2015-002368-17 ( EudraCT Number )
First Posted: February 15, 2016    Key Record Dates
Last Update Posted: November 6, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by University Hospital, Montpellier:
Prosthetic breast surgery
Locoregional anesthesia
Pectoral nerve block
Pain
Postoperative analgesia

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents