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Completed

NCT Number: NCT02741232

Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block for Breast Cancer Surgery

In this study, the investigators will compare the intraoperative opioid consumption for patients undergoing breast cancer surgery. The patients will be divided in two groups, the first one will receive a pectoral nerve block right after induction of anesthesia and the second one, the control group, will not receive the pectoral block. Our hypothesis is that the pectoral nerve block reduces the opioid consumption during the surgery.

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Key information

Conditions

Age range

18 year–85 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Hôpital Maisonneuve-Rosemont

Montreal, Quebec, H1T 2M4, Canada

About this study

After induction of general anesthesia with propofol, remifentanil and succinylcholine, the patients will be divided either in the pectoral block group or the control group (sham block). Both groups will receive the same perioperative and postoperative anesthetic protocol. The investigator in charge of the patient will leave the operative room right before the completion of the pectoral block (or the sham block) to preserve randomisation and the block will be performed by another investigator. The pectoral block is performed under ultrasound guidance with 10 cc of lidocaine 1% with epinephrine 1/400000 between the pectoralis major muscle and the pectoralis minor muscle and 20 cc of the same solution between the pectoralis minor muscle and the serratus anterior muscle at the third rib. Anesthesia will be maintained with sevoflurane for a bispectral (BIS) index between 45 and 60. Analgesia will be provided with a perfusion of remifentanil adjusted to maintain a mean arterial blood pressure (MAP) in the range of ± 10% of the basal MAP (mean of the last three MAPs obtained before surgical incision, under sevoflurane-only anesthesia). The total remifentanil consumption will be assessed and compared between the groups. The investigators believe that the pectoral nerve block will significantly reduce the intraoperative remifentanil consumption.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • ASA 1 to 3 inclusively
  • breast cancer surgery with or without axillary dissection

Exclusion criteria

  • any contraindication to the pectoral nerve block (coagulopathy, infection, pre- existing neuropathy, local anesthetic allergy and refusal of local anesthesia)
  • refusal to participate in the study
  • patient with dementia
  • preoperative breast pain
  • preoperative opioid consumption
  • breast reconstructive surgery
  • bilateral surgery
  • pregnant patient

Treatment and study plan

Lidocaine 1% with epinephrine 1/400000

Drug

Other names: xylocaine with epinephrine

sham block

Other

Primary outcomes

  1. Intraoperative remifentanil consumption for the first 30 minutes of surgery

    Time frame: 30 minutes

Secondary outcomes

  1. Total intraoperative remifentanil consumption

    Time frame: 2 hours

  2. Total intraoperative sevoflurane consumption

    Time frame: 2 hours

  3. Postoperative pain evaluation

    Time frame: 30 minutes

    using the numerical rating scale

  4. Postoperative nausea and vomiting evaluation

    Time frame: 30 minutes

  5. Total time in the recovery room

    Time frame: 60 minutes

  6. Postoperative opioid consumption

    Time frame: 1 hour

    dilaudid consumption

Sponsors and collaborators

Lead sponsor

Maisonneuve-Rosemont Hospital

Other

Registry information

Official study title

Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Apr 18, 2016
Registry last updated
Mar 20, 2019

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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