Comparison of Exparel to Bupivacaine With Dexamethasone in TAP Block

Pain Clinical Trial

— TapBlock  

Official title:

Comparison Between Bupivacaine Extended-Release Liposome Injection (Exparel) Versus Bupivacaine With Dexamethasone in Transversus Abdominis Plane Block: A Prospective Randomized Controlled Trial

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02179892
• Other study ID #: IRB00071635
• Status: Terminated
• Phase: Phase 4
• First received: June 30, 2014
• Last updated: July 13, 2017
• Start date: July 2014
• Est. completion date: June 6, 2015

Study information

• Verified date: July 2017
• Source: Emory University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Description:

Group 1 will be administered 266 mg of Exparel, diluted to 30 mL. Group 2 will be given 28 mL of 0.375% bupivacaine and 8mg/2 mL dexamethasone.Before injection of the study medication, 2mL of normal saline with be injected under ultrasound visualization to ensure needle tip is in the transversus abdominis plane.Randomization will occur following the written informed consent and prior to the start of the surgical procedure. Postoperatively, study patients will receive intravenous acetaminophen 1000mg every 8 hours for 3 doses, then oral acetaminophen 650mg every 6 hours. Subjects will also have patient-controlled analgesia (PCA) with morphine or hydromorphone. The research staff recording data will be blinded to the treatment group. Demographic data will be recorded, including age, date of birth, height and weight to ensure similarity between the two groups. A medical history will be obtained as well as surgical and anesthesia details. Study patients will be followed for 72 hours postoperatively to record the amount of opioid consumption, as well as other pain score data using the Visual Analogue Scale (VAS).The subject's participation will end 72 hours after surgery. A telephone interview will occur with the subject if hospital discharge occurs prior to 72 hours.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 9
• Est. completion date: June 6, 2015
• Est. primary completion date: June 6, 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Bupivacaine Extended-Release Liposome Injection (Exparel)
266mg/30mL of Exparel will be injected via unilateral TAP block
• Bupivacaine and Dexamethasone Injection
As a combination injection, 28 ml of 0.375% bupivacaine and 8 mg/2ml of dexamethasone will be injected via unilateral TAP block.
• IV Acetaminophen
Intravenous (IV) acetaminophen 1000 mg every 8 hours for 8 doses.
• Oral Acetaminophen
Oral acetaminophen 650 mg every 6 hours.

Locations

Country	Name	City	State
United States	Emory University Hospital	Atlanta	Georgia
United States	Emory University Hospital Midtown	Atlanta	Georgia

Sponsors (1)

Lead Sponsor	Collaborator
Colette Curtis MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Mean Visual Analogue Scale (VAS) Pain Score at Rest	The VAS method of pain assessment (scale of 1- 10) will be used to measure the participant's pain level at rest each day during the 72 hours post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.	Post-Surgery 24 Hours, 48 Hours, 72 Hours
Secondary	Mean Visual Analogue Scale (VAS) Pain Score With Movement	The VAS method of pain assessment (scale of 1-10) will be used to measure the patient's level of pain with movement each day during the 72 hour post surgical period. One represents the lowest level of pain and 10 represents the highest level of pain.	Post-Surgery 24 Hours, 48 Hours, 72 Hours
Secondary	Mean Time of First Opioid Use	The time of first opioid use after surgery will be recorded for up to 72 hours.	Post-surgery (Up to 72 Hours)