Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine

NeuroTherapia, Inc.

Status: Completed

Conditions: Major Abdominal Surgery; Pain, Postoperative

Treatments: Procedure: Epidural analgesia; Drug: EXPAREL; Procedure: TAP block; Drug: Bupivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02996227

16-1449 -EXPLANE Block

Details and patient eligibility

About

Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Full description

The investigator goal is to compare the analgesic efficacy of TAP blocks with liposomal bupivacaine (Exparel) and continuous epidural blocks in patients who are scheduled for major lower abdominal surgery. To assess whether TAP block with Exparel is noninferior to continuous epidural analgesia on pain management, defined as noninferior for both pain control and total opioid consumption for 72 hours, in patients who had major lower abdominal surgery.

Enrollment: 514 patients

Sex: All

Ages: 18 to 85 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Written informed consent
• 18-85 years old
• ASA Physical Status 1-3
• Scheduled for elective open or laparoscopic abdominal surgery, including colorectal and hysterectomy surgeries
• Anticipated hospitalization of three nights
• Expected requirement for parenteral opioids for at least 72 hours for postoperative pain
• Able to use IV PCA systems.

Exclusion criteria

• Hepatic disease, e.g. twice the normal levels of liver enzymes
• Kidney disease, e.g. twice the normal level of serum creatinine
• Bupivacaine sensitivity or known allergy
• Women who are pregnant or breastfeeding
• Anticoagulants considered to be a contraindication for epidural or TAP blocks.
• Surgeries with high port sites will be excluded

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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514 participants in 2 patient groups

TAP block with Exparel

Experimental group

Description:

Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)

Treatment:

Procedure: TAP block

Drug: EXPAREL

Epidural analgesia with Bupivacaine

Active Comparator group

Description:

Epidural catheters with an infusion of Bupivacaine standard solution without additives

Treatment:

Procedure: Epidural analgesia

Drug: Bupivacaine