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PAIN - Postoperative Analgesia INvestigation

NCT02111746 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 350

Last updated 2018-10-16

Study results available
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Summary

The purpose of this study is to assess the efficacy of the intraoperative injection of prolonged acting (liposomal) bupivacaine in postoperative pain control after truncal surgical incisions.

Conditions

  • Postoperative Pain

Interventions

DRUG

Exparel

Participants will receive 266mg of liposomal bupivicaine (equivalent of one 1.3% 20ml vial of EXPAREL®) diluted in 60ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

DRUG

Bupivacaine hydrochloride

Participants will receive 125mg of bupivacaine hydrochloride (equivalent of one 0.25% 50ml or five 0.25% 10ml vials ) diluted in 30ml of preservative-free normal (0.9%) sterile saline for a total volume of 80mL. Drug will be administered at the end of the procedure just prior to wound closure.

DRUG

Patient Controlled Analgesia (PCA)

Patients will have access to the standard Patient Controlled Analgesia (PCA) offered at the Memorial Hermann Hospital - Texas Medical Center. The PCA drug will be Dilaudid (hydromorphone). Initial dosing will be per the standard hospital protocol of 0.2 mg demand dose, 10 minute lockout, 2 mg per hour max, 0.4 mg rescue dose. Adjustments to the PCA dosing will be made based on clinical needs. Patients will receive PCA until the third postoperative day

Sponsors & Collaborators

  • The University of Texas Health Science Center, Houston

    lead OTHER

Principal Investigators

  • Kristofer M Charlton-Ouw, MD FACS · University of Texas Health Science Center, Department of Cardiothoracic and Vascular Surgery, UT Medical School at Houston

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-11-20
Primary Completion
2017-05-03
Completion
2017-06-30
FDA Drug
Yes

Countries

  • United States

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 NCT02111746 on ClinicalTrials.gov