CClinicalTrials.gg
Status unknownNCT03713255Updated Oct 3, 2022

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

An interventional study of PVB group and MTP block group in Breast Cancer, Acute Pain and Anesthesia, sponsored by Ottawa Hospital Research Institute. Status unknown at 1 site in Canada. Open to female participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2022-10-03.

Sponsored by Ottawa Hospital Research Institute · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Sep 2022), so the status shown — last known as Recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
150
Allocation
Randomized
Ages
18 Years to 65 Years
Sex
Female
01

Study summary

This study will compare the analgesic effects of midpoint transverse process to pleura (MTP) block to control as well as thoracic paravertebral block.

Read the 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.

02

Conditions studied

  • Breast Cancer
  • Acute Pain
  • Anesthesia

Keywords

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

Breast Neoplasms

12,547 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's planned enrollment of 150 is above the median of 72 across 9,305 interventional studies indexed under Breast Neoplasms.

Browse Breast Neoplasms studies →

Lead sponsor

Ottawa Hospital Research Institute is the lead sponsor of 538 studies on the registry; 100 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
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

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
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
150 participants (estimated)

Study arms

  • Active comparator
    PVB group

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

    Procedure: PVB group

  • Experimental
    MTP block group

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

    Procedure: MTP block group

  • Sham comparator
    control group

    local anesthetic infiltration subcutaneous 1% lidocaine

    Procedure: Control Group

Interventions

  • ProcedurePVB 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).

  • ProcedureMTP 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).

  • ProcedureControl 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).

06

What researchers measure

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.

    Time frame: 48 hours

Secondary outcomes

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

    Measured by the Quality of recovery (QoR-15 scale).

    Time frame: 48 hours

07

Study locations

1 of 1 sites recruiting
  • The Ottawa Hospital
    Ottawa, Ontario, Canada
    • Ioana Costache, MD · Contact
    Recruiting
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 3, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT03713255
Lead sponsor
Ottawa Hospital Research Institute
Responsible party
Sponsor
First posted
Oct 19, 2018
Start date
Jan 1, 2020
Primary completion
Dec 31, 2023 (estimated)
Completion
Dec 31, 2023 (estimated)
Last update
Oct 3, 2022

Study contacts

Ioana Costache, MD
Contact
icostache@toh.ca
(613) 737-8187
Ioana Costache, MD
principal investigator · Ottawa Hospital, Ottawa Hospital Research Institute

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Sep 2022. You cannot join it, but the record below documents what was studied.

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