Recruiting

Mid-point Block

Sponsor:

Ottawa Hospital Research Institute

Code:

NCT03713255

Conditions

Breast Cancer

Acute Pain

Anesthesia

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

PVB group

MTP block group

Control Group

Study Details

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.

Conditions

Breast Cancer

Acute Pain

Anesthesia

Study ID

NCT03713255

Start date

Jan 1, 2020

Status verified date

Sep, 2022

Completion date

Dec 31, 2023

Anticipated

Primary completion date

Dec 31, 2023

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18 - 65

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

150 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

active comparator: PVB group

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

experimental: MTP block group

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

sham comparator: control group

local anesthetic infiltration subcutaneous 1% lidocaine

Interventions

PVB group

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).

MTP block group

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).

Control Group

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

  • Postoperative analgesia during the first 24 hours. [ Time Frame: 48 hours ]

Central Contacts and Locations

Central contacts

Ioana Costache, MD

(613) 737-8187icostache@toh.ca

Locations

The Ottawa Hospital

Recruiting

Ottawa, Ontario, Canada

More Information

Sponsor

Ottawa Hospital Research Institute

Last update posted

Oct 3, 2022

Last verified

Sep, 2022

Keywords

  • Regional Anesthesia
  • Paravertebral Block
  • Breast Cancer Surgery
  • MTP block

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Ottawa Hospital Research Institute on 2022-10-03.