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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

514 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-12-31

Study Completion Date

2019-10-31

Brief Summary

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

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Detailed Description

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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.

Conditions

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Pain, Postoperative Major Abdominal Surgery

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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TAP block with Exparel

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

Group Type EXPERIMENTAL

TAP block

Intervention Type PROCEDURE

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

EXPAREL

Intervention Type DRUG

Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.

Epidural analgesia with Bupivacaine

Epidural catheters with an infusion of Bupivacaine standard solution without additives

Group Type ACTIVE_COMPARATOR

Epidural analgesia

Intervention Type PROCEDURE

Epidural catheters will be inserted preoperatively.

Bupivacaine

Intervention Type DRUG

Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.

Interventions

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TAP block

Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.

Intervention Type PROCEDURE

Epidural analgesia

Epidural catheters will be inserted preoperatively.

Intervention Type PROCEDURE

EXPAREL

Once the target area is positioned, plain bupivacaine 0.25%, 20ml will be given to open the space and then single dose (10ml) of liposomal bupivacaine (Exparel) mixed with saline (10 ml) will be injected in each side. Total dose of Exparel will be 20 mL.

Intervention Type DRUG

Bupivacaine

Once an epidural catheter is successfully positioned, an infusion will be initiated intraoperatively. Bupivacaine standard solution without additives will be prepared for each patient in epidural group.

Intervention Type DRUG

Other Intervention Names

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Liposomal Bupivacaine Marcaine

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No