Nerve Blocks in Alloplastic Breast Reconstruction

NCT04860843 | Unknown

• 1 other identifier: H20-00787
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

Pain management is a major concern in oncologic breast surgery and reconstruction. Significant risks for acute and chronic pain after surgery might be reduced through improved pain control pre-operatively. Addition of regional anesthesia to a multimodal peri-operative pain management protocol offers a promising solution for improved recovery. For patients undergoing mastectomy with immediate alloplastic breast reconstruction, this RCT compares TPVB+Pecs local anesthetic block with TPVB local anesthetic block and Pecs placebo normal saline block for their effect on acute pain, chronic pain, opioid consumption, opioid-related side effects, patient-reported quality of recovery after surgery, and length of stay.

Conditions

Surgery, Plastic; Mastectomy; Nerve Block; Breast Reconstruction

Outcome Measures

Primary Outcomes (4)

• Rate of participant recruitment

  The definitive trial will be considered feasible if \> 50% of eligible patients are enrolled in this pilot study.

  1 year

• Rate of successful nerve blocks

  The definitive trial will be considered feasible if \> 90% of blocks are successful.

  1 year

• Rate of participant retention

  The definitive trial will be considered feasible if there is \> 90% participant retention at 6 months.

  6 months

• Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale.

  The Numerical Rating Scale is an 11-point scale (0-10), where a lower number indicates less pain. We will consider preliminary evidence of efficacy for a definitive trial if the 80% confidence interval for the between-group difference in average pain score in the 24-hour postoperative period favours LA block.

  24 hours post-operatively

Secondary Outcomes (14)

• Opioid analgesia requirements

  24 hours post-operatively

• Acute patient-reported pain scores assessed by the Numerical Rating Scale

  Up to 24 hours post-operatively

• Post-operative nausea measured by the Numerical Rating Scale

  24 hours post-operatively

• Post-operative vomiting measured by number of vomiting episodes

  Up to 48 hours post-operatively

• Quality of Recovery Score measured by the Quality of Recovery 15 Questionnaire

  Baseline (prior to surgery) and 24 hours after surgery

Study Arms (2)

Local anesthetic TPVB + Local anesthetic Pecs block

EXPERIMENTAL

Patients will receive a thoracic paravertebral with pecs block, both with local anesthetic infiltrate.

Drug: Thoracic paravertebral block; Drug: Pecs block

Local anesthetic TPVB + Sham Pecs block

SHAM COMPARATOR

Patients will receive a thoracic paravertebral with local anesthetic infiltrate and a pecs block with saline infiltrate.

Drug: Thoracic paravertebral block; Drug: Sham Pecs block

Interventions

Thoracic paravertebral block DRUG

Participants will receive a thoracic paravertebral with local anesthetic infiltrate (30ml of 0.35% ropivacaine with 1:400K epinephrine).

Local anesthetic TPVB + Local anesthetic Pecs block; Local anesthetic TPVB + Sham Pecs block

Pecs block DRUG

Participants will receive a pecs block with local anesthetic infiltrate (30ml of 0.25% ropivacaine with 1:400K epinephrine).

Local anesthetic TPVB + Local anesthetic Pecs block

Sham Pecs block DRUG

Participants will receive a and a pecs block with saline infiltrate (30ml normal saline; 0.9% NaCl).

Local anesthetic TPVB + Sham Pecs block

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be female, and at least 19 years old.
• Patients must be ASA grade I or II.
• Patients must be undergoing total mastectomy with IBR using tissue expander or implant, with or without axillary surgery.

You may not qualify if:

• Patients have a known contraindication for a regional block: known coagulation disorder, treatment with anticoagulants, infection at the injection site, known allergy to medication in the study.
• Patients who are pregnant at the time of surgery.
• Patients having bilateral mastectomy and immediate alloplastic breast reconstruction (as only one side can be blocked to prevent local anesthesia toxicity).
• Patients with ASA Class III or IV.
• Patients with BMI\>35kg/m2.
• Patients weighing less than 50kg.
• Patients living/staying outside of 1-hour driving distance from hospital.

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

Mount St Joseph Hospital

Vancouver, British Columbia, V5T 3N4, Canada

RECRUITING

Related Publications (1)

• Wells H, Malik K, Brasher PMA, Bovill E, Van Laeken N, Warburton R, Prabhakar C, Li XL, Isaac KV. The addition of interpectoral and pectoserratus fascial plane blocks to paravertebral blocks for analgesia after total mastectomy and immediate breast reconstruction: a pilot feasibility randomized controlled trial. Can J Anaesth. 2025 Sep;72(9):1387-1396. doi: 10.1007/s12630-025-03030-1. Epub 2025 Sep 22.

  PMID: 40983823 DERIVED

Study Officials

• Kathryn Isaac, MD MPH FRCSC

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kathryn Isaac, MD MPH FRCSC

CONTACT

604-827-0438; kathryn.isaac@ubc.ca

Raveena Gowda, MSc

CONTACT

research.plastics@ubc.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: April 27, 2021
• Study Start: May 1, 2021
• Primary Completion: May 1, 2024
• Study Completion: August 1, 2024
• Last Updated: January 8, 2024

Record last verified: 2024-01

Locations

CA (1)