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PECS I Block for Breast Subpectoral Implant Surgery

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: NCT02849236
Recruitment Status : Recruiting
First Posted : July 29, 2016
Last Update Posted : February 15, 2019
Sponsor:
Information provided by (Responsible Party):
University Hospital, Lille

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
Pain, Postoperative Drug: Ropivacaine (PECS bloc) Drug: Placebo Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study
Study Start Date : October 2016
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


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 Name: saline

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 Name: ropivacaine




Primary Outcome Measures :
  1. Morphine consumption [ Time Frame: 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 :
  1. First administration of morphine [ Time Frame: During the first 24 postoperative hours ]
    Time elapsed between tracheal extubation and first administration of morphine

  2. Post-operative nausea and/or vomiting [ Time Frame: During the first 24 postoperative hours ]
    Number of nausea and/or vomiting episodes in the twenty-four hours after surgery

  3. Intra-operative opioids consumption [ Time Frame: During procedure execution ]
    Sufentanil consumption during anesthesia

  4. Post-operative anti-emetic consumption [ Time Frame: During the first 24 postoperative hours ]
    Consumption of anti-emetic drugs after surgery

  5. Post-operative pain [ Time Frame: 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

  6. 4-point sedation scale [ Time Frame: 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


  7. Aldrete score [ Time Frame: 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.

  8. Time physiological function recovery [ Time Frame: During the first six postoperative hours after tracheal extubation ]
    Ability to drink, to eat, to urinate, to walk



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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)

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): NCT02849236


Contacts
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Contact: Benoit Tavernier, MD,PhD benoit.tavernier@chru-lille.fr

Locations
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France
Hôpital Roger Salengro, CHU de Lille Recruiting
Lille, France
Principal Investigator: Benoit Tavernier, MD,PhD         
Sponsors and Collaborators
University Hospital, Lille
Investigators
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Principal Investigator: Benoit Tavernier, MD, PhD University Hospital, Lille

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Responsible Party: University Hospital, Lille
ClinicalTrials.gov Identifier: NCT02849236    
Other Study ID Numbers: 2015_17
2016-000157-12 ( EudraCT Number )
First Posted: July 29, 2016    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by University Hospital, Lille:
PECS block,
pectoral block,
breast augmentation
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents