Recruiting

Nerve Blocks

Sponsor:

University of British Columbia

Code:

NCT04860843

Conditions

Surgery, Plastic

Mastectomy

Nerve Block

Breast Reconstruction

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

Interventions

Thoracic paravertebral block

Pecs block

Sham Pecs block

Study Details

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

Study ID

NCT04860843

Start date

May 1, 2021

Status verified date

Jan, 2024

Completion date

Aug, 2024

Anticipated

Primary completion date

May, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 19+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

30 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Local anesthetic TPVB + Local anesthetic Pecs block

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

sham comparator: Local anesthetic TPVB + Sham Pecs block

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

Interventions

Thoracic paravertebral block

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

Pecs block

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

Sham Pecs block

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

Primary outcome measure

  • Rate of participant recruitment [ Time Frame: 1 year ]
  • Rate of successful nerve blocks [ Time Frame: 1 year ]
  • Rate of participant retention [ Time Frame: 6 months ]
  • Average pain score in the 24-hour post-operative period assessed by the Numerical Rating Scale. [ Time Frame: 24 hours post-operatively ]

Central Contacts and Locations

Central contacts

Kathryn Isaac, MD MPH FRCSC

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

Raveena Gowda, MSc

research.plastics@ubc.ca

Locations

Mount St Joseph Hospital

Recruiting

Vancouver, British Columbia, Canada, V5T 3N4

Contacts

kathryn isaac

604-336-9488kathryn.isaac@ubc.ca

More Information

Sponsor

University of British Columbia

Last update posted

Jan 8, 2024

Last verified

Jan, 2024

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by University of British Columbia on 2024-01-08.