Comparison of Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine: A Randomized, Controlled Trial
Overview
- Phase
- Not Applicable
- Intervention
- TAP block
- Conditions
- Pain, Postoperative
- Sponsor
- The Cleveland Clinic
- Enrollment
- 514
- Locations
- 2
- Primary Endpoint
- VRS Pain Score
- Status
- Completed
- Last Updated
- 2 years ago
Overview
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.
Investigators
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
Arms & Interventions
TAP block with Exparel
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
Intervention: TAP block
TAP block with Exparel
Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel)
Intervention: EXPAREL
Epidural analgesia with Bupivacaine
Epidural catheters with an infusion of Bupivacaine standard solution without additives
Intervention: Epidural analgesia
Epidural analgesia with Bupivacaine
Epidural catheters with an infusion of Bupivacaine standard solution without additives
Intervention: Bupivacaine
Outcomes
Primary Outcomes
VRS Pain Score
Time Frame: The Verbal Response Scale was recorded every 4 hours for 72 hours after discharge from the PACU.
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 the worst pain ever experienced. The VRS will be recorded every 4 hours for 72 hours after discharge from the PACU. Summary statistics of pain scores are reported as means ± standard deviations of average pain during the first 72 postoperative hours
Total Opioid Consumption
Time Frame: During the 72 hours after discharge from the PACU.
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 Outcomes
- Hemodynamic Instability, Defined as Mean Arterial Pressure (MAP) <55 mmHg or Systolic Blood Pressure <80 mmHg.(Data was recorded at 15-s intervals during the initial 72 postoperative hours.)
- Length of Hospital Stay(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)
- Cumulative Duration of Activity(During the initial 72 postoperative hours.)
- Opioid-related Side Effect(The first, second and third postoperative mornings)
- Quality of Recovery After Anesthesia(The first and third postoperative mornings)