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

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

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03713255
Enrollment
150
Registered
2018-10-19
Start date
2020-01-01
Completion date
2023-12-31
Last updated
2022-10-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Anesthesia, Breast Cancer

Keywords

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

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.

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).

Sponsors

Ottawa Hospital Research Institute
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Masking description

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

Intervention model description

Prospective, randomized, quadruple-blinded, three arm parallel group clinical trial.

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 65 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Postoperative analgesia during the first 24 hours.48 hoursMeasured by opioid (equivalents of morphine) consumption and pain scores on a numerical rating scale.

Secondary

MeasureTime frameDescription
Post-operative quality of recovery during the first 24 hours.48 hoursMeasured by the Quality of recovery (QoR-15 scale).

Countries

Canada

Contacts

Primary ContactIoana Costache, MD
icostache@toh.ca(613) 737-8187

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026