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

Opioid Use Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04655339
• Other study ID #: 019-428
• Status: Not yet recruiting
• Phase: Phase 2/Phase 3
• Start date: December 10, 2020
• Est. completion date: July 1, 2024

Study information

• Verified date: November 2020
• Source: Baylor Research Institute
• Contact: Christine Sanchez, MA
• Phone: 214.820.4589
• Email: Christine.Sanchez2[@]BSWHealth.org
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 165
• Est. completion date: July 1, 2024
• Est. primary completion date: July 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Opioid Use

Intervention

Drug:
• Bilateral abdominal Lap-TAP
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Baylor Research Institute

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	opioid dosage requested	opioid dosage requested post-TAP block	30days
Secondary	visual analog scores (VAS)		30days
Secondary	length of stay		30days
Secondary	anti-emetic dosage		30days