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PECS Block vs. Multimodal Analgesia for Prevention of Persistent Postoperative Pain in Breast Surgery

NCT03084536 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 134

Last updated 2024-12-24

Study results available
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Summary

In this double blinded randomized placebo-controlled trial, 160 subjects scheduled for breast surgery involving the axilla will be administered a multimodal pain regimen including acetaminophen, dexamethasone, celecoxib, and gabapentin. 80 subjects will also receive a Pectoral Nerve blocks I and II (PECS I and II block) preoperatively.

Conditions

Interventions

DRUG

Bupivacaine

-Given after general anesthesia

DRUG

Gabapentin

* As per routine care * Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years.

DRUG

Celecoxib

* As per routine care * Will not be prescribed for any patient with preexisting kidney disease or ≥ 65 years. * Naproxen will be substituted for celecoxib in patients with sulfa allergies.

DRUG

Acetaminophen

-As per routine care

DRUG

Midazolam

-As per routine care

DRUG

Fentanyl

-As per routine care

Sponsors & Collaborators

  • Washington University School of Medicine

    lead OTHER

Principal Investigators

  • Ryan C Guffey, M.D. · Washington University School of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2017-06-07
Primary Completion
2021-02-25
Completion
2021-02-25
FDA Drug
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Diseases

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 NCT03084536 on ClinicalTrials.gov