Postoperative Analgesia in Laparoscopic Abdominal Surgery After Exparel Via TAP or Local Infiltration

NCT03927326 | Unknown

• 1 other identifier: STUDY00007182
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief Summary

This study evaluates differences in how administering liposomal bupivacaine via two different methods affects postoperative pain control in laparoscopic abdominal surgery patients. Half the participants will receive liposomal bupivacaine via a transverses abdominis plane block while the other half will receive liposomal bupivacaine via local infiltration.

Conditions

Pain, Postoperative; Anesthesia, Local; Anesthesia; Functional; Anesthesia; Opioid Use

Outcome Measures

Primary Outcomes (1)

• 24 hour post operative opioid consumption

  Listed in morphine daily equivalents.

  24 hours postoperative

Secondary Outcomes (5)

• 12 hour post operative opioid consumption

  12 hours postoperative

• 48 hour post operative opioid consumption

  48 hours postoperative

• Pain intensity at 12 hours post operative

  12 hours

• Pain intensity at 24 hours post operative

  24 hours

• Hospital length of stay

  Until end of hospital stay, typically 3 days

Study Arms (2)

Local infiltration

EXPERIMENTAL

Liposomal bupivacaine (266mg) will be directly infiltrated by the surgeon into the surgical laparoscopic wound sites.

Drug: Exparel 266 MG Per 20 ML Injection

Transversus abdominis plane block

EXPERIMENTAL

Liposomal bupivacaine (266mg) will be used in a ultrasound guided transversus abdominis plane block.

Drug: Exparel 266 MG Per 20 ML Injection

Interventions

Exparel 266 MG Per 20 ML Injection DRUG

Liposomal bupivacaine

Local infiltration; Transversus abdominis plane block

Eligibility Criteria

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

You may qualify if:

• Patients scheduled for elective laparoscopic colorectal surgery at UWMC requiring inpatient stay

You may not qualify if:

• Patients on chronic pain mediations equaling or exceeding \> 25 morphine daily equivalents
• Patients allergic to bupivacaine
• Patients with ASA status IV, V, or VI
• Patients unable to consent
• Patients that are pregnant
• Patients that are incarcerated
• Patients receiving procedures in addition to laparoscopic colorectal procedure
• Patients on systemic anticoagulation precluding them from regional blocks

Sponsors & Collaborators

• University of Washington: lead

Related Publications (7)

• Bergese SD, Ramamoorthy S, Patou G, Bramlett K, Gorfine SR, Candiotti KA. Efficacy profile of liposome bupivacaine, a novel formulation of bupivacaine for postsurgical analgesia. J Pain Res. 2012;5:107-16. doi: 10.2147/JPR.S30861. Epub 2012 May 1.

  PMID: 22570563 BACKGROUND

• 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 BACKGROUND

• Mulligan RP, Morash JG, DeOrio JK, Parekh SG. Liposomal Bupivacaine Versus Continuous Popliteal Sciatic Nerve Block in Total Ankle Arthroplasty. Foot Ankle Int. 2017 Nov;38(11):1222-1228. doi: 10.1177/1071100717722366. Epub 2017 Aug 8.

  PMID: 28786304 BACKGROUND

• Sternlicht A, Shapiro M, Robelen G, Vellayappan U, Tuerk IA. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical analgesia in robotic laparoscopic prostatectomy: a pilot study. Local Reg Anesth. 2014 Dec 12;7:69-74. doi: 10.2147/LRA.S64515. eCollection 2014.

  PMID: 25540595 BACKGROUND

• Hadzic A, Abikhaled JA, Harmon WJ. Impact of volume expansion on the efficacy and pharmacokinetics of liposome bupivacaine. Local Reg Anesth. 2015 Dec 7;8:105-11. doi: 10.2147/LRA.S88685. eCollection 2015.

  PMID: 26673040 BACKGROUND

• Candiotti KA, Sands LR, Lee E, Bergese SD, Harzman AE, Marcet J, Kumar AS, Haas E. Liposome Bupivacaine for Postsurgical Analgesia in Adult Patients Undergoing Laparoscopic Colectomy: Results from Prospective Phase IV Sequential Cohort Studies Assessing Health Economic Outcomes. Curr Ther Res Clin Exp. 2013 Dec 27;76:1-6. doi: 10.1016/j.curtheres.2013.12.001. eCollection 2014 Dec.

  PMID: 25031661 BACKGROUND

• Gastevski D. Infiltration of liposome bupivacaine into the transversus abdominis plane for postsurgical pain management in a 39-year-old female undergoing laparoscopic cholecystectomy. Pain Med. 2014 Aug;15(8):1312-5. doi: 10.1111/pme.12356. Epub 2014 Jan 21.

  PMID: 24612211 BACKGROUND

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Injections

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Vanessa Loland, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alan Chang, MD

CONTACT

714-878-0850; achang5@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident, School of Medicine: Anesthesiology and Pain Medicine

Model Details: Unblinded randomized trial

Study Record Dates

• First Submitted: April 18, 2019
• First Posted: April 25, 2019
• Study Start: August 1, 2019
• Primary Completion: July 1, 2020
• Study Completion: July 1, 2020
• Last Updated: April 25, 2019

Record last verified: 2019-04

Data Sharing

• IPD Sharing: Will not share