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Nerve Blocks in Alloplastic Breast Reconstruction

NCT04860843 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2024-01-08

No results posted yet for this study

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

Interventions

DRUG

Thoracic paravertebral block

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

DRUG

Pecs block

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

DRUG

Sham Pecs block

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

Sponsors & Collaborators

  • University of British Columbia

    lead OTHER

Principal Investigators

  • Kathryn Isaac, MD MPH FRCSC · University of British Columbia

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
19 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-01
Primary Completion
2024-05-31
Completion
2024-08-31

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04860843 on ClinicalTrials.gov