Clinical trial NCT02996227: Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
Official title: Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Pain, Postoperative
Major Abdominal Surgery
Lead sponsor: The Cleveland Clinic
Sponsor class: OTHER
First posted: 2016-12-19
Enrollment: 514
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

Detailed 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.

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

Primary outcomes:
measure: VRS Pain Score
timeFrame: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
measure: Total Opioid Consumption
timeFrame: During the 72 hours after discharge from the PACU.
Secondary outcomes:
measure: Cumulative Duration of Activity
timeFrame: During the initial 72 postoperative hours.
measure: Opioid-related Side Effect
timeFrame: The first, second and third postoperative mornings
measure: Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.
timeFrame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.
measure: Quality of Recovery After Anesthesia
timeFrame: The first and third postoperative mornings
measure: Length of Hospital Stay
timeFrame: From date of hospital admission until the date of hospital discharge or date of death from any cause, whichever came first, assessed up to 100 weeks
Other outcomes:
measure: Duration of Hypoxemia
timeFrame: Data was recorded at 15-s intervals during the initial 72 postoperative hours.
measure: Persistent Postoperative Incisional Pain- MBPI Pain Intensity
timeFrame: At the 90-day follow up
measure: Persistent Postoperative Incisional Pain- MBPI Pain Interference
timeFrame: At the 90-day follow up
Locations:
city: Cleveland
country: United States
facility: Cleveland Clinic Foundation
state: Ohio
city: Cleveland
country: United States
facility: The Cleveland Clinic Foundation
state: Ohio
Study officials:
affiliation: The Cleveland Clinic
name: Alparslan Turan, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Turan A, Cohen B, Elsharkawy H, Maheshwari K, Soliman LM, Babazade R, Ayad S, Hassan M, Elkassabany N, Essber HA, Kessler H, Mao G, Esa WAS, Sessler DI; EXPLANE Study Group. Transversus abdominis plane block with liposomal bupivacaine versus continuous epidural analgesia for major abdominal surgery: The EXPLANE randomized trial. J Clin Anesth. 2022 May;77:110640. doi: 10.1016/j.jclinane.2021.110640. Epub 2021 Dec 27.