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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03713255
Recruitment Status : Recruiting
First Posted : October 19, 2018
Last Update Posted : October 3, 2022
Sponsor:
Information provided by (Responsible Party):
Ottawa Hospital Research Institute

Study Description
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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.

Condition or disease Intervention/treatment Phase
Breast Cancer Acute Pain Anesthesia Procedure: PVB group Procedure: MTP block group Procedure: Control Group Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 150 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: Quadruple (participant, care provider, investigator, outcomes assessor)
Primary Purpose: Treatment
Official Title: Analgesic Benefits of the Novel Mid-point Transverse Process to Pleura (MTP) Block for Ambulatory Breast Cancer Surgery: A Randomized Controlled Trial
Actual Study Start Date : January 1, 2020
Estimated Primary Completion Date : December 31, 2023
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: PVB group
paravertebral blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL
 Procedure: 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).
Experimental: MTP block group
MTP blocks with 0.5% ropivacaine and epinephrine 2.5 mcg/mL
 Procedure: 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).
Sham Comparator: control group
local anesthetic infiltration subcutaneous 1% lidocaine
 Procedure: 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).


Outcome Measures
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Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Post-operative quality of recovery during the first 24 hours. [ Time Frame: 48 hours ]
    Measured by the Quality of recovery (QoR-15 scale).


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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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): NCT03713255


Contacts
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Contact: Ioana Costache, MD (613) 737-8187 icostache@toh.ca

Locations
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Canada, Ontario
The Ottawa Hospital Recruiting
Ottawa, Ontario, Canada
Contact: Ioana Costache, MD         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Investigators
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Principal Investigator: Ioana Costache, MD Ottawa Hospital, Ottawa Hospital Research Institute
More Information
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Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT03713255    
Other Study ID Numbers: 20180259-01H
First Posted: October 19, 2018    Key Record Dates
Last Update Posted: October 3, 2022
Last Verified: September 2022

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ottawa Hospital Research Institute:
Regional Anesthesia
Paravertebral Block
Breast Cancer Surgery
MTP block
Additional relevant MeSH terms:
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Breast Neoplasms
Acute Pain
Neoplasms by Site
Neoplasms
 Breast Diseases
Skin Diseases
Pain
Neurologic Manifestations