Comparison of Perioperative Opioid Consumption Following... | NCT02741232

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

NCT02741232

Sponsor

Maisonneuve-Rosemont Hospital

Status

Completed

Last Update Posted

Mar 20, 2019Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Nerve Block
Mastectomy

Interventions

Lidocaine 1% with epinephrine 1/400000
sham block

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2019

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Mar 2016

Primary Completion Date

Aug 30, 2017Actual

Completion Date

Sep 15, 2017Actual

First Submitted Date

Apr 13, 2016

First Submission Date that Met QC Criteria

Apr 15, 2016

First Posted Date

Apr 18, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 18, 2019

Last Update Posted Date

Mar 20, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Olivier Verdonck, Clinical Assistant Professor, Maisonneuve-Rosemont HospitalPrincipal Investigator

Lead Sponsor

Maisonneuve-Rosemont HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Pectoral nerve block	Active Comparator	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
Sham block	Sham Comparator	No needle or injection will be used	Other: sham block

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Lidocaine 1% with epinephrine 1/400000	Drug		Pectoral nerve block	xylocaine with epinephrine

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Intraoperative remifentanil consumption for the first 30 minutes of surgery		30 minutes

Secondary Outcomes

Measure	Description	Time Frame
Total intraoperative remifentanil consumption		2 hours
Total intraoperative sevoflurane consumption		2 hours
Postoperative pain evaluation

Other Outcomes

Not provided

Eligibility Module

Eligibility 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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

85 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hôpital Maisonneuve-Rosemont		Montreal	Quebec	H1T 2M4	Canada

Intervention Browse Module

MeSH Terms

ID	Term
D008012	Lidocaine
D004837	Epinephrine

Ancestor Terms

ID	Term
D000083	Acetanilides
D000813	Anilides
D000577	Amides
D009930	Organic Chemicals
D000814

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Browse Branches

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