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

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ClinicalTrials.gov Identifier: NCT02741232
Recruitment Status : Completed
First Posted : April 18, 2016
Last Update Posted : March 20, 2019
Sponsor:
Information provided by (Responsible Party):
Olivier Verdonck, Maisonneuve-Rosemont Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Nerve Block Mastectomy Drug: Lidocaine 1% with epinephrine 1/400000 Other: sham block Not Applicable

Detailed Description:
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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Comparison of Perioperative Opioid Consumption Following Pectoral Nerve Block Under General Anesthesia for Breast Cancer Surgery: A Randomized Clinical Trial
Study Start Date : March 2016
Actual Primary Completion Date : August 30, 2017
Actual Study Completion Date : September 15, 2017


Arm Intervention/treatment
Active Comparator: Pectoral nerve block
After induction of general anesthesia and under ultrasound visual guidance, pectoral block is performed with 30 mL total of local anesthetic (1% lidocaine + 1/400000 epinephrine). 10 mL of local anesthetic between pectoralis major muscle and pectoralis minor muscle and 20 mL between pectoralis minor muscle and serratus anterior muscle at the third rib.
Drug: Lidocaine 1% with epinephrine 1/400000
Other Name: xylocaine with epinephrine

Sham Comparator: Sham block
No needle or injection will be used
Other: sham block



Primary Outcome Measures :
  1. Intraoperative remifentanil consumption for the first 30 minutes of surgery [ Time Frame: 30 minutes ]

Secondary Outcome Measures :
  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



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Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

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): NCT02741232


Locations
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Canada, Quebec
Hôpital Maisonneuve-Rosemont
Montréal, Quebec, Canada, H1T 2M4
Sponsors and Collaborators
Maisonneuve-Rosemont Hospital

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Responsible Party: Olivier Verdonck, Clinical Assistant Professor, Maisonneuve-Rosemont Hospital
ClinicalTrials.gov Identifier: NCT02741232     History of Changes
Other Study ID Numbers: 15075
First Posted: April 18, 2016    Key Record Dates
Last Update Posted: March 20, 2019
Last Verified: March 2019
Keywords provided by Olivier Verdonck, Maisonneuve-Rosemont Hospital:
analgesics, opioids
pectoral block
Additional relevant MeSH terms:
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Lidocaine
Epinephrine
Racepinephrine
Analgesics, Opioid
Epinephryl borate
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Anti-Arrhythmia Agents
Voltage-Gated Sodium Channel Blockers
Sodium Channel Blockers
Membrane Transport Modulators
Molecular Mechanisms of Pharmacological Action
Narcotics
Analgesics
Adrenergic alpha-Agonists
Adrenergic Agonists
Adrenergic Agents
Neurotransmitter Agents
Adrenergic beta-Agonists
Bronchodilator Agents
Autonomic Agents
Anti-Asthmatic Agents
Respiratory System Agents
Mydriatics
Sympathomimetics
Vasoconstrictor Agents