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

Study Overview
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Brief Summary
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Comparison of Bilateral Transversus Abdominis Plane Block with Exparel versus Continuous Epidural Analgesia With Bupivacaine

Detailed Description
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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.

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

Conditions
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Pain, Postoperative, Major Abdominal Surgery

Intervention / Treatment
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* Procedure: TAP block
* Procedure: Epidural analgesia
* Drug: EXPAREL
* Drug: Bupivacaine


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

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

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| VRS Pain score | 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. | Discharge from PACU until 72 hours after the end of surgery | 
| Total opioid consumption | 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. | Discharge from PACU until 72 hours after the end of surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Activity after 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. | Discharge from PACU until 72 hours after the end of surgery | 
| Opioid related side effect | 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. | The first, second and third postoperative mornings | 
| Blood pressure | Visi mobile patient monitoring system will be used to obtain blood pressure of the patient for 72 hours. | Discharge from PACU until 72 hours after the end of surgery | 
| Quality of recovery after anesthesia | Quality of recovery will be measured using QoR scale. Patients will be questioned on morning of POD1 and 3. | The first and third postoperative mornings | 
| Length of hospital stay | The length of hospital stay will be measured as days. | 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 | 
| Total cost of care | 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. | 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 |