NCT03713255

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P50-P75 for not_applicable breast-cancer

Timeline
Completed

Started Jan 2020

Typical duration for not_applicable breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 27, 2018

Completed
22 days until next milestone

First Posted

Study publicly available on registry

October 19, 2018

Completed
1.2 years until next milestone

Study Start

First participant enrolled

January 1, 2020

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2023

Completed
Last Updated

October 3, 2022

Status Verified

September 1, 2022

Enrollment Period

4 years

First QC Date

September 27, 2018

Last Update Submit

September 29, 2022

Conditions

Breast CancerAcute PainAnesthesia

Keywords

Regional AnesthesiaParavertebral BlockBreast Cancer SurgeryMTP block

Outcome Measures

Primary Outcomes (1)

  • Postoperative analgesia during the first 24 hours.

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

    48 hours

Secondary Outcomes (1)

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

    48 hours

Study Arms (3)

PVB group

ACTIVE COMPARATOR

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

Procedure: PVB group

MTP block group

EXPERIMENTAL

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

Procedure: MTP block group

control group

SHAM COMPARATOR

local anesthetic infiltration subcutaneous 1% lidocaine

Procedure: Control Group

Interventions

PVB groupPROCEDURE

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).

PVB group
MTP block groupPROCEDURE

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).

MTP block group
Control GroupPROCEDURE

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).

control group

Eligibility Criteria

Age18 Years - 65 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The Ottawa Hospital

Ottawa, Ontario, Canada

RECRUITING

MeSH Terms

Conditions

Breast NeoplasmsAcute Pain

Interventions

Control Groups

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesPainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Epidemiologic Research DesignEpidemiologic MethodsInvestigative TechniquesResearch DesignMethods

Study Officials

  • Ioana Costache, MD

    Ottawa Hospital, Ottawa Hospital Research Institute

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ioana Costache, MD

CONTACT

(613) 737-8187icostache@toh.ca

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Masking Details
Quadruple (participant, care provider, investigator, outcomes assessor)
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 27, 2018

First Posted

October 19, 2018

Study Start

January 1, 2020

Primary Completion

December 31, 2023

Study Completion

December 31, 2023

Last Updated

October 3, 2022

Record last verified: 2022-09

Locations

CA(1)