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Completed

NCT Number: NCT02849236

PECS I Block for Breast Subpectoral Implant Surgery

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.

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Key information

Conditions

Pain, Postoperative Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Roger Salengro, CHU de Lille

Lille, France

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Ropivacaine (PECS bloc)

Drug

Ropivacaine 3.75mg/mL

Injection of a local anesthetic between pectoral major and pectoral minor muscles

Other names: ropivacaine

Placebo

Drug

20 mL saline 0.9%

Other names: saline

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

University Hospital, Lille

Other

Registry information

Official study title

Analgesic Efficacy of the Pectoral Nerve Block Type 1 for Breast Subpectoral Implant Surgery: A Randomized Controlled Study

Important dates

Study start
2016
Primary completion
2020
Study completion
2020
First posted
Jul 29, 2016
Registry last updated
Aug 26, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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