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

• ClinicalTrials.gov Identifier: NCT02996227
• Recruitment Status: Completed
• First Posted: December 19, 2016
• Last Update Posted: January 18, 2020
• Sponsor: The Cleveland Clinic
• Information provided by (Responsible Party): The Cleveland Clinic

Study Description

Brief Summary:

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

Condition or disease	Intervention/treatment	Phase
Pain, Postoperative; Major Abdominal Surgery	Procedure: TAP block; Procedure: Epidural analgesia; Drug: EXPAREL; Drug: Bupivacaine	Not Applicable

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.

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 532 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
• Study Start Date: December 2016
• Actual Primary Completion Date: June 2019
• Actual Study Completion Date: October 2019

Arms and Interventions

Arm	Intervention/treatment
Experimental: TAP block with Exparel; Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)	Procedure: TAP block; Transversus Abdominis Plane (TAP) blocks will be performed preoperatively. An in-plane ultrasound will be used in TAP block procedure.; Drug: 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.; Other Name: Liposomal Bupivacaine
Active Comparator: Epidural analgesia with Bupivacaine; Epidural catheters with an infusion of Bupivacaine standard solution without additives	Procedure: Epidural analgesia; Epidural catheters will be inserted preoperatively.; 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.; Other Name: Marcaine

Outcome Measures

Primary Outcome Measures :

1. VRS Pain score [ Time Frame: Discharge from PACU until 72 hours after the end of surgery ]
   Pain scores will be measured using a Verbal Response Scale (VRS). VRS is a scale from 0 to 10 where 0 signifies no pain and 10 signifies worst pain ever experienced. The VRS will be recorded every 30 minutes in the recovery area for the first 2 hours, then every 4 hours thereafter while awake for 72 hours.
2. Total opioid consumption [ Time Frame: Discharge from PACU until 72 hours after the end of surgery ]
   Opioid consumption will be measured as the total amount of opioids (converted to morphine sulfate equivalents) used during the 72 hours after the end of surgery.

Secondary Outcome Measures :

1. Activity after surgery [ Time Frame: Discharge from PACU until 72 hours after the end of surgery ]
   ViSi mobile (Sotera Wireless) patient monitoring system, a platform for comprehensive vital sign monitoring will be used to quantify patient activity over the initial 72 postoperative hours. This system continuously measures position (lying versus sitting) and activity.
2. Opioid related side effect [ Time Frame: The first, second and third postoperative mornings ]
   We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate opioid-related side effect. ORSDS questionnaires will be administered by a trained research fellow.
3. Blood pressure [ Time Frame: Discharge from PACU until 72 hours after the end of surgery ]
   Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours.
4. Quality of recovery after anesthesia [ Time Frame: The first and third postoperative mornings ]
   Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3.
5. Length of hospital stay [ Time Frame: 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 ]
   The length of hospital stay will be measured as days.
6. Total cost of care [ Time Frame: 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 ]
   The total cost of hospital stay will be collected at hospital discharge day or date of death from any cause, which comes first, assessed up to 100 weeks.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 85 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

United States, Ohio

Cleveland Clinic Foundation

Cleveland, Ohio, United States, 44195

Sponsors and Collaborators

The Cleveland Clinic

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: The Cleveland Clinic
• ClinicalTrials.gov Identifier: NCT02996227
• Other Study ID Numbers: 16-1449 -EXPLANE Block
• First Posted: December 19, 2016
• Last Update Posted: January 18, 2020
• Last Verified: January 2020

Additional relevant MeSH terms:

Pain, Postoperative; Postoperative Complications; Pathologic Processes; Pain; Neurologic Manifestations; Bupivacaine; Anesthetics, Local; Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Sensory System Agents; Peripheral Nervous System Agents