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Clinical Trials/NCT03713255
NCT03713255RecruitingNot Applicable

Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial

Ottawa Hospital Research Institute1 site in 1 country150 target enrollmentStarted: January 1, 2020Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Recruiting
Enrollment
150
Locations
1
Primary Endpoint
Postoperative analgesia during the first 24 hours.

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description

Quadruple (participant, care provider, investigator, outcomes assessor)

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

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

Arms & Interventions

PVB group

Active Comparator

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

Intervention: PVB group (Procedure)

MTP block group

Experimental

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

Intervention: MTP block group (Procedure)

control group

Sham Comparator

local anesthetic infiltration subcutaneous 1% lidocaine

Intervention: Control Group (Procedure)

Outcomes

Primary Outcomes

Postoperative analgesia during the first 24 hours.

Time Frame: 48 hours

Measured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.

Secondary Outcomes

  • Post-operative quality of recovery during the first 24 hours.(48 hours)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

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