Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids

Study Overview
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Brief Summary
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In this study we aim to investigate the efficacy of laparoscopic-guided TAP block in reducing post-operative opioid use following minimally invasive foregut and bariatric surgeries. We will also compare and report the analgesia produced by Bupivacaine HCL vs Exparel ®, a prolonged slow release Liposomal Bupivacaine formulation. Secondary outcomes assessed will be VAS pain scores, length of stay, and PONV dosage administered.

Official Title
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Efficacy of Laparoscopic Transversus Abdominis Plane (TAP) Block to Reduce Post-operative Opioids Following Bariatric and Minimally Invasive Foregut Surgery

Conditions
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Opioid Use

Intervention / Treatment
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* Drug: Bilateral abdominal Lap-TAP


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: gastric bypass & sleeve gastrectomy, duodenal switch and minimally invasive elective anti-reflux foregut surgeries such as - hiatal hernia repair, fundoplication and Heller myotomy. Exclusion Criteria: Subjects who are known to be i. Allergic to Bupivacaine ii. Chronic opioid users Page 4 iii. Had/have neurological conditions iv. Have a diagnosis of chronic pain syndrome which requires them to consume regular analgesics > 3-months v. American Society of Anesthesiologists (ASA) Class IV & V patients with severe systemic disease that is a constant threat to life. vi. Patients with abdominal drain use vii. Patients with significant cardiovascular, liver or renal disease viii. Presence of contraindications for bariatric or foregut surgery. ix. Patients presenting postoperative complications will be excluded from final analysis & final data set x. History of bariatric or foregut surgery xi. Patients who are pregnant xii. Patients who are under the age of 18

Ages Eligible for Study
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Minimum Age: 18 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group-1<br>Bilateral abdominal Lap-TAP block injection near incision site with 0.25% Bupivacaine HCl (30cc) with 30ml being injected bilaterally. Remaining residual is injected into port incision sites. | Drug: Bilateral abdominal Lap-TAP<br>* A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.<br>|
| Experimental: Group-2<br>Bilateral abdominal Lap-TAP liposomal Bupivacaine (Exparel®) injection with 133mg (20ml) Exparel® plus bupivacaine 0.25% (30ml), plus 10ml of normal saline for a total volume of 60ml, injecting 30ml each side. | Drug: Bilateral abdominal Lap-TAP<br>* A total of 30ml of anesthetic (0.25% Bupivacaine HCL), 0.25% Liposomal Bupivacaine (Exparel®) or control will be injected into the transversus abdominis plane bilaterally. A long spinal needle attached to a 30cc syringe with the TAP block solution or control will be used to inject the patient. The needle puncture will be halfway between the subcostal margin and anterior superior iliac spine at the midclavicular line. With laparoscopic guidance, needle will enter through the skin, external oblique and internal oblique. Once the needle is in place, injection of 30 ml on each side will be applied between the internal oblique and transversus abdominis muscle. The injection of bupivacaine into this abdominal wall induces an observable bulge, indicating accuracy of the procedure. These steps will be repeated on the contralateral side of the abdomen. All patients will receive 10 ml bupivacaine 0.25% pre-incision infiltration.<br>|
| No Intervention: Group-3<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| opioid dosage requested | opioid dosage requested post-TAP block | 30days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| visual analog scores (VAS) |  | 30days | 
| length of stay |  | 30days | 
| anti-emetic dosage |  | 30days |