Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

NCT02179892 | Terminated Phase 4 Results

• 1 other identifier: IRB00071635
• Study Type: interventional
• Target: 9
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to compare the efficacy and duration of bupivacaine extended-release liposome injection (Exparel) versus bupivacaine with dexamethasone in transversus abdominis plane (TAP) blocks for patients undergoing abdominal surgery at Emory University Hospital and Emory University Hospital Midtown. The investigators hypothesize that Exparel will provide greater postoperative pain relief than bupivacaine with dexamethasone. The investigators plan to enroll up to 50 male and female subjects meeting inclusion and exclusion criteria who will be randomized to receive either Exparel (Group 1) or bupivacaine with epinephrine and dexamethasone (Group 2) in the TAP block to achieve at least 22 subjects in each group

Conditions

Pain

Keywords

anesthesia; surgery; pain

Outcome Measures

Primary Outcomes (1)

• Mean Opioid Consumption

  The investigators will collect the total amount of opioid consumption for the 72 hour post operative period in each group.

  Post Surgery (Up to 72 Hours)

Secondary Outcomes (3)

• Mean Visual Analogue Scale (VAS) Pain Score at Rest

  Post-Surgery 24 Hours, 48 Hours, 72 Hours

• Mean Visual Analogue Scale (VAS) Pain Score With Movement

  Post-Surgery 24 Hours, 48 Hours, 72 Hours

• Mean Time of First Opioid Use

  Post-surgery (Up to 72 Hours)

Study Arms (2)

Group 1-Exparel

ACTIVE COMPARATOR

Bupivacaine Extended-Release Liposome Injection (Exparel)will be administered via TAP block procedure

Drug: Bupivacaine Extended-Release Liposome Injection (Exparel); Drug: IV Acetaminophen; Drug: Oral Acetaminophen

Group 2-Bupivacaine and Dexamethasone IV

ACTIVE COMPARATOR

Bupivacaine and Dexamethasone Injection will be administered via TAP block procedure.

Drug: Bupivacaine and Dexamethasone Injection; Drug: IV Acetaminophen; Drug: Oral Acetaminophen

Interventions

Bupivacaine Extended-Release Liposome Injection (Exparel) DRUG

266mg/30mL of Exparel will be injected via unilateral TAP block

Group 1-Exparel

Bupivacaine and Dexamethasone Injection DRUG

As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.

Group 2-Bupivacaine and Dexamethasone IV

IV Acetaminophen DRUG

Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.

Group 1-Exparel; Group 2-Bupivacaine and Dexamethasone IV

Oral Acetaminophen DRUG

Oral acetaminophen 650 mg every 6 hours.

Group 1-Exparel; Group 2-Bupivacaine and Dexamethasone IV

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male and female patients undergoing scheduled abdominal surgery at Emory University Hospital or Emory University Hospital Midtown
• Patients willing and able to provide written informed consent

You may not qualify if:

• Patients less than 18 years of age, since Exparel has not been studied in this age group
• Patients who are pregnant or lactating, since Exparel has not been shown to be safe in this population, and because of potential drug transfer to child
• Patients with uncontrolled diabetes since dexamethasone may cause hyperglycemia
• Patients with liver dysfunction, since bupivacaine is hepatically metabolized
• Patients with renal failure, since bupivacaine is renally excreted, defined as requiring hemodialysis or renal replacement therapy
• Patients with allergy to one of the study drugs
• Patients with local infection, which may be exacerbated by dexamethasone
• Patients with significant opioid tolerance, defined as taking at least 60 mg oral morphine per day, 3 mg oral oxycodone per day, 25 mcg/hr fentanyl patch, 25 mg oral oxymorphone per day, 8 mg of oral hydromorphone per day or an equianalgesic dose of another opioid for one week or longer
• Patients with known coagulopathy, since bleeding risk is higher Patients who are getting neuraxial anesthesia for surgery

Sponsors & Collaborators

• Colette Curtis MD: lead

Study Sites (2)

Emory University Hospital Midtown

Atlanta, Georgia, 30308, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Pain

Interventions

Bupivacaine; Calcium Dobesilate; Acetaminophen

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Benzenesulfonates; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Arylsulfonates; Arylsulfonic Acids; Sulfonic Acids; Sulfur Acids; Sulfur Compounds; Acetanilides

Results Point of Contact

• Title: Dr. Colette Curtis
• Organization: Emory University

ccurti3@emory.edu

404-778-3900

Study Officials

• Colette Curtis, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: June 30, 2014
• First Posted: July 2, 2014
• Study Start: July 1, 2014
• Primary Completion: June 6, 2015
• Study Completion: June 6, 2015
• Last Updated: August 11, 2017
• Results First Posted: August 11, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2)