Bilateral Transversus Abdominis Plane Block With Exparel Verus Continuous Epidural Analgesia With Bupivacaine
- Conditions
- Pain, PostoperativeMajor Abdominal Surgery
- Interventions
- Registration Number
- NCT02996227
- Lead Sponsor
- The Cleveland Clinic
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 514
- 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.
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description TAP block with Exparel TAP block Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel) Epidural analgesia with Bupivacaine Epidural analgesia Epidural catheters with an infusion of Bupivacaine standard solution without additives TAP block with Exparel EXPAREL Bilateral Transversus Abdominis Plane (TAP) block procedure following injection of liposomal bupivacaine (Exparel) Epidural analgesia with Bupivacaine Bupivacaine Epidural catheters with an infusion of Bupivacaine standard solution without additives
- Primary Outcome Measures
Name Time Method VRS Pain Score 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 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 Outcome Measures
Name Time Method 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. Visi mobile patient monitoring system will be used to obtain the blood pressure of the patient for 72 hours. Data was recorded at 15-s intervals and downloaded daily to a laptop. We re-defined postoperative hypotension as any MAP \<65 mmHg, because few patients experienced such profound hypotension as originally planned and because papers published since the trial were designed to identify 65 mmHg as the harm threshold for both myocardial and renal injury. Summary statistics of hemodynamic instability are reported as means ± standard deviations of average MAP during the first 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 The length of hospital stay will be measured as days.
Cumulative Duration of Activity During the initial 72 postoperative hours. defined as the total duration of time patients spent sitting or standing, as determined by the mobile monitoring system during the initial 72 postoperative hours.
Opioid-related Side Effect The first, second and third postoperative mornings We will use 4-point Opioid-Related Symptom Distress Scale (ORSDS) to evaluate the frequency, severity, and bothersomeness of: nausea, vomiting, constipation, difficulty passing urine, difficulty concentrating,drowsiness or difficulty staying awake, feeling lightheaded or dizzy,feeling confused, feelings of general fatigue or weakness, itchiness, dry mouth, and headache. Severity: 1=Slightly severe 2=Moderately severe 3=Severe 4=Very severe; Frequency: 1=Rarely 2=Occasionally 3=Frequently 4=Almost constantly; Bothersomeness (rescaled to a 4-point scale): 0.8=not at all 1.6=a little bit 2.4= somewhat 3.2=quite a bit 4.0=very much. If a patient did not experience the symptom in the past 24 hours, a score of 0 was assigned to each domain. Opioid-related side effect is the sum of the patient's frequency, severity, and bothersomeness, scored from 0 to 12. Higher scores indicate greater severity.
Quality of Recovery After Anesthesia The first and third postoperative mornings Quality of recovery (QoR) will be measured using QoR-15 questionnaire which includes 15 11-point numerical rating scale. For positive items, 0 = "none of the time \[poor\]" to 10 = "all of the time \[excellent\]"; Conversely, for negative items, 10 = "none of the time \[excellent\]" to 0 = "all of the time \[poor\]". Quality of recovery is the sum of all the 15 questions, with a score ranging from 0 (extremely poor QoR) to 150 (excellent QoR).
Trial Locations
- Locations (2)
Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States
The Cleveland Clinic Foundation
🇺🇸Cleveland, Ohio, United States