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Clinical trial

Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial

ID
Name
16-1449 -EXPLANE Block
Description
Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine
Trial arms
Trial start
2016-12-01
Estimated PCD
2019-06-01
Trial end
2019-10-01
Status
Completed
Treatment
TAP block
Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.
Arms:
TAP block with Exparel
Epidural analgesia
Epidural catheters will be inserted preoperatively.
Arms:
Epidural analgesia with Bupivacaine
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.
Arms:
TAP block with Exparel
Other names:
Liposomal Bupivacaine
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.
Arms:
Epidural analgesia with Bupivacaine
Other names:
Marcaine
Size
514
Primary endpoint
VRS Pain Score
The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
Total Opioid Consumption
During the 72 hours after discharge from the PACU.
Eligibility criteria
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
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['NA'], 'designInfo': {'allocation': 'RANDOMIZED', 'interventionModel': 'PARALLEL', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE'}}, 'enrollmentInfo': {'count': 514, 'type': 'ACTUAL'}}
Updated at
2024-01-31

1 organization

2 products

3 indications

Organization
The Cleveland Clinic
Product
EXPAREL
Indication
Pain
Indication
Postoperative
Indication
Major Abdominal Surgery
Product
Bupivacaine