Clinical trial

Regional Nerve Blocks in Alloplastic Breast Reconstructive Surgery: A Pilot, Randomized Controlled Trial

Name

H20-00787

Description

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.

Trial arms

Trial start

2021-05-01

Estimated PCD

2024-05-01

Trial end

2024-08-01

Status

Recruiting

Treatment

Thoracic paravertebral block

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

Arms:

Local anesthetic TPVB + Local anesthetic Pecs block, Local anesthetic TPVB + Sham Pecs block

Pecs block

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

Arms:

Local anesthetic TPVB + Local anesthetic Pecs block

Sham Pecs block

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

Arms:

Local anesthetic TPVB + Sham Pecs block

Size

Primary endpoint

Rate of participant recruitment

1 year

Rate of successful nerve blocks

1 year

Rate of participant retention

6 months

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

24 hours post-operatively

Eligibility criteria

Inclusion Criteria: 1. Patients must be female, and at least 19 years old. 2. Patients must be ASA grade I or II. 3. Patients must be undergoing total mastectomy with IBR using tissue expander or implant, with or without axillary surgery. Exclusion Criteria: 1. 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. 2. Patients who are pregnant at the time of surgery. 3. Patients having bilateral mastectomy and immediate alloplastic breast reconstruction (as only one side can be blocked to prevent local anesthesia toxicity). 4. Patients with ASA Class III or IV. 5. Patients with BMI\>35kg/m2. 6. Patients weighing less than 50kg. 7. Patients living/staying outside of 1-hour driving distance from hospital.

Protocol

{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}

Updated at

2024-01-08

1 organization

3 products

5 indications

Organization

University of British Columbia

Product

Thoracic paravertebral block

Indication

Surgery

Indication