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

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 19
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Mount St Joseph Hospital
RECRUITING
Vancouver
Contact Information
Primary
Kathryn Isaac, MD MPH FRCSC
kathryn.isaac@ubc.ca
604-827-0438
Backup
Raveena Gowda, MSc
research.plastics@ubc.ca
Time Frame
Start Date: 2021-05-01
Estimated Completion Date: 2024-08
Participants
Target number of participants: 30
Treatments
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.
Related Therapeutic Areas
Sponsors
Leads: University of British Columbia

This content was sourced from clinicaltrials.gov