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Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial

Primary Purpose

Breast Cancer, Acute Pain, Anesthesia

Status
Recruiting
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
PVB group
MTP block group
Control Group
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring Regional Anesthesia, Paravertebral Block, Breast Cancer Surgery, MTP block

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • English or French Speaking
  • Scheduled for major breast surgery
  • ASA physical status classification I-III
  • BMI <30kg/m2

Exclusion Criteria:

  • Prior ipsilateral breast surgery
  • Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest
  • Contraindications to regional anesthesia
  • Patient refusal of regional technique
  • Chronic pain disorder
  • Chronic opioid use
  • Inability to provide informed consent

Sites / Locations

  • The Ottawa HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Experimental

Sham Comparator

Arm Label

PVB group

MTP block group

control group

Arm Description

paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL

local anesthetic infiltration subcutaneous 1% lidocaine

Outcomes

Primary Outcome Measures

Postoperative analgesia during the first 24 hours.
Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.

Secondary Outcome Measures

Post-operative quality of recovery during the first 24 hours.
Measured by the Quality of recovery (QoR-15 scale).

Full Information

First Posted
September 27, 2018
Last Updated
September 29, 2022
Sponsor
Ottawa Hospital Research Institute
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1. Study Identification

Unique Protocol Identification Number
NCT03713255
Brief Title
Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial
Official Title
Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
January 1, 2020 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.
Detailed Description
Paravertebral blocks (PVBs) are frequently used for regional anesthesia for breast surgery. Ultrasound-guided paravertebral block is an advanced skill. The needle tip can be difficult to visualize with ultrasound, and the proximity to neurovascular structures as well as the pleura presents a risk of neurovascular injection and pneumothorax respectively. The midpoint transverse-process to pleura (MTP) block incorporates a novel needle endpoint that is technically easier to achieve and more distant from neurovascular structures and the pleura compared to traditional PVB. This study will compare the analgesic effects of MTP block to control and PVB.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer, Acute Pain, Anesthesia
Keywords
Regional Anesthesia, Paravertebral Block, Breast Cancer Surgery, MTP block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Quadruple (participant, care provider, investigator, outcomes assessor)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
PVB group
Arm Type
Active Comparator
Arm Description
paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL
Arm Title
MTP block group
Arm Type
Experimental
Arm Description
MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
local anesthetic infiltration subcutaneous 1% lidocaine
Intervention Type
Procedure
Intervention Name(s)
PVB group
Intervention Description
Patients in this group will receive preoperative ultrasound-guided thoracic paravertebral block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Intervention Type
Procedure
Intervention Name(s)
MTP block group
Intervention Description
Patients in this group will receive preoperative ultrasound-guided mid-point transverse process to pleura block using ropivacaine 0.5% with epinephrine 2.5 mcg/mL, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Intervention Type
Procedure
Intervention Name(s)
Control Group
Intervention Description
Patients in this group will receive preoperative ultrasound-guided sham block with subcutaneous local anesthetic injection using lidocaine 1%, and supplemental standardized anesthetic/analgesic regimen (Acetaminophen / NSAIDs / opioids for breakthrough pain).
Primary Outcome Measure Information:
Title
Postoperative analgesia during the first 24 hours.
Description
Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Post-operative quality of recovery during the first 24 hours.
Description
Measured by the Quality of recovery (QoR-15 scale).
Time Frame
48 hours

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: English or French Speaking Scheduled for major breast surgery ASA physical status classification I-III BMI <30kg/m2 Exclusion Criteria: Prior ipsilateral breast surgery Pre-existing neurological deficit or peripheral neuropathy involving the ipsilateral chest Contraindications to regional anesthesia Patient refusal of regional technique Chronic pain disorder Chronic opioid use Inability to provide informed consent
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Ioana Costache, MD
Phone
(613) 737-8187
Email
icostache@toh.ca
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ioana Costache, MD
Organizational Affiliation
Ottawa Hospital, Ottawa Hospital Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
The Ottawa Hospital
City
Ottawa
State/Province
Ontario
Country
Canada
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioana Costache, MD

12. IPD Sharing Statement

Learn more about this trial

Mid-point Transverse Process to Pleura Block for Breast Cancer Surgery: A Randomized Controlled Trial

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