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

NCT ID: NCT03927326

Last Updated: 2019-04-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-08-31

Study Completion Date

2020-07-31

Brief Summary

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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.

Detailed Description

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Liposomal bupivacaine is a newer formulation of a local anesthetic that is commonly used for local infiltration, peripheral nerve blocks, and neuraxial anesthesia. This new formulation allows the effects of bupivacaine to last up to 72 hours as it is slowly released from a liposome. It is FDA approved for local infiltration and has recently been approved for interscalene blocks.

A transversus abdominis plane block is a fascial plane block that is performed routinely for postoperative pain relief for some abdominal incisions. It is performed by placing local anesthetic between the internal oblique and transverses abdominis muscle planes where it will provide analgesia to several dermatomes of the abdomen in hopes of improving postoperative pain relief and reducing postoperative opioid requirement.

Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Unblinded randomized trial
Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Local infiltration

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

Group Type EXPERIMENTAL

Exparel 266 MG Per 20 ML Injection

Intervention Type DRUG

Liposomal bupivacaine

Transversus abdominis plane block

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

Group Type EXPERIMENTAL

Exparel 266 MG Per 20 ML Injection

Intervention Type DRUG

Liposomal bupivacaine

Interventions

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Exparel 266 MG Per 20 ML Injection

Liposomal bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Washington

OTHER

Sponsor Role lead

Responsible Party

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Alan Chang

Resident, School of Medicine: Anesthesiology and Pain Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Vanessa Loland, MD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Central Contacts

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Alan Chang, MD

Role: CONTACT

714-878-0850

References

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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.

Reference Type BACKGROUND
PMID: 22570563 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 22067185 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28786304 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25540595 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 26673040 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25031661 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24612211 (View on PubMed)

Other Identifiers

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STUDY00007182

Identifier Type: -

Identifier Source: org_study_id

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