Exparel Use in Bilateral TAP Blocks for Postoperative Pain Control

NCT03878888 | Completed Phase 4 DMC FDA Drug

• 1 other identifier: stluke
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

To determine if Exparel (Liposomal Bupivacaine, an FDA approved drug) use in ultrasound guided Transversus Abdominis Plane (TAP) blocks may reduce opioid requirement use postoperatively, reduce pain scores postoperatively, reduce incidence of nausea in the postop period, and decrease length of hospital stay

Conditions

Postoperative Pain; Surgery; Anesthesia, Local

Keywords

liposomal bupivacaine; TAP block; pain control

Outcome Measures

Primary Outcomes (2)

• Reduce opioid requirement use (calculated oral morphine equivalents (OME)) for 2-3 days time after surgery.

  will review opioid/narcotic use in patient's chart

  up until postoperative day 5

• Reduce pain scores after surgery

  Numerical Rating Scale: 0-10; 0 being no pain, 10 being worst pain imaginable possible

  up until postoperative day 5

Secondary Outcomes (2)

• Reduce incidence of nausea postoperatively

  up until Postoperative day 5

• Decrease length of hospital stay

  up until postoperative day 5

Study Arms (2)

Exparel use in TAP block

EXPERIMENTAL

Exparel used in bilateral TAP block for open abdomen surgery

Drug: Exparel 266 MG Per 20 ML Injection

no TAP block

NO INTERVENTION

these patients, N=20, did not received a bilateral TAP block for postoperative pain control. Instead, pain control involves PO/IV pain medications

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

patients receive Exparel in bilateral TAP blocks for open abdomen surgery

Also known as: liposomal bupivacaine

Exparel use in TAP block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women of Reproductive Potential
• Men of Reproductive Potential
• Minorities
• Healthy Controls/Volunteers
• Employees/Students
• Vulnerable populations (trauma victims, students \> 18 yrs age, aged infirm, substance abusers, impoverished, terminally ill,)

You may not qualify if:

• advanced dementia, not oriented to time or place
• advanced liver disease
• pregnant patients
• allergy to amide local anesthesia
• allergy to methemoglobinemia

Sponsors & Collaborators

• St. Luke's Hospital, Pennsylvania: lead

Study Sites (1)

St. Luke's University Hospital Health Network

Bethlehem, Pennsylvania, 18015, United States

Location

Related Publications (4)

• Seagle BL, Miller ES, Strohl AE, Hoekstra A, Shahabi S. Transversus abdominis plane block with liposomal bupivacaine compared to oral opioids alone for acute postoperative pain after laparoscopic hysterectomy for early endometrial cancer: a cost-effectiveness analysis. Gynecol Oncol Res Pract. 2017 Aug 22;4:12. doi: 10.1186/s40661-017-0048-7. eCollection 2017.

  PMID: 28852531 BACKGROUND

• Fayezizadeh M, Majumder A, Neupane R, Elliott HL, Novitsky YW. Efficacy of transversus abdominis plane block with liposomal bupivacaine during open abdominal wall reconstruction. Am J Surg. 2016 Sep;212(3):399-405. doi: 10.1016/j.amjsurg.2015.12.026. Epub 2016 Apr 12.

  PMID: 27156796 RESULT

• Feierman DE, Kronenfeld M, Gupta PM, Younger N, Logvinskiy E. Liposomal bupivacaine infiltration into the transversus abdominis plane for postsurgical analgesia in open abdominal umbilical hernia repair: results from a cohort of 13 patients. J Pain Res. 2014 Aug 16;7:477-82. doi: 10.2147/JPR.S65151. eCollection 2014.

  PMID: 25170277 RESULT

• Gorfine SR, Onel E, Patou G, Krivokapic ZV. Bupivacaine extended-release liposome injection for prolonged postsurgical analgesia in patients undergoing hemorrhoidectomy: a multicenter, randomized, double-blind, placebo-controlled trial. Dis Colon Rectum. 2011 Dec;54(12):1552-9. doi: 10.1097/DCR.0b013e318232d4c1.

  PMID: 22067185 RESULT

Related Links

• Ching, Heidi. A comparison of Exparel to Bupivacaine in TAP block for Abdominal Gynecologic surgery. clinicaltrials.gov : NCT03304444.
• Turan Et. Al. Bilateral Transversus Abdominis Plane Block with Exparel vs. Continuous Epidural Analgesia with Bupivacaine. Clinical trials.gov: NCT02996227

MeSH Terms

Conditions

Pain, Postoperative; Agnosia

Interventions

Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Anna Ng Pellegrino, MD

  St. Luke's University Health Network - Anesthesia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: no masking; will provide qualified patients the opportunity to receive Exparel (liposomal bupivacaine) in Bilateral TAP blocks for open abdomen surgery
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: experimental group: patients having open abdominal surgery that will receive a bilateral TAP block with Exparel control group: patients having open abdominal surgery that will not receive a bilateral TAP block with Exparel

Study Record Dates

• First Submitted: March 9, 2019
• First Posted: March 18, 2019
• Study Start: January 15, 2019
• Primary Completion: July 1, 2019
• Study Completion: July 1, 2019
• Last Updated: December 17, 2020

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)