NCT03730402

Brief Summary

This study attempts to demonstrate improvement in analgesia in a more diverse laparoscopic surgery group with the use of laparoscopic assisted transversus abdominis plane blocks. The investigators will compare bupivacaine (treatment arm 1) versus liposomal bupivacaine (treatment arm 2) versus port site injection of local anesthesia with injection of saline placebo (control). The hypothesis is that liposomal bupivacaine will result in improved analgesia when compared to bupivacaine LAPB and control. The investigators further hypothesize that bupivacaine LAPB will be more effective than the control.

Trial Health

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Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
34

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Feb 2019

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 2018

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 5, 2018

Completed
3 months until next milestone

Study Start

First participant enrolled

February 4, 2019

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 14, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 14, 2021

Completed
Last Updated

July 1, 2021

Status Verified

June 1, 2021

Enrollment Period

2.2 years

First QC Date

November 2, 2018

Last Update Submit

June 28, 2021

Conditions

Opioid Use

Keywords

post-operative analgesia

Outcome Measures

Primary Outcomes (1)

  • Narcotic Usage

    post-operative narcotic usage expressed in morphine equivalents

    24 hours

Secondary Outcomes (4)

  • Narcotic Usage

    7 days

  • Pain Scores

    24 hours

  • Post-Operative Nausea

    24 hours

  • Post-operative emesis

    24 hours

Study Arms (3)

bupivacaine block

ACTIVE COMPARATOR

laparoscopic assisted plane block of standardized dose of bupivacaine plain

Drug: Bupivacaine

liposomal bupivacaine block (Exparel 266 milligram Per 20 ML)

ACTIVE COMPARATOR

laparoscopic assisted plane block of standardized dose of bupivacaine plain

Drug: Exparel 266 milligram Per 20 ML Injection

saline block

PLACEBO COMPARATOR

laparoscopic assisted plane block with placebo saline injection

Drug: Saline

Interventions

BupivacaineDRUG

utilizing local anesthetic to perform a regional block under laparoscopic guidance

Also known as: Marcaine
bupivacaine block
Exparel 266 milligram Per 20 ML InjectionDRUG

utilizing local anesthetic to perform a regional block under laparoscopic guidance

Also known as: Exparel, liposomal bupivacaine
liposomal bupivacaine block (Exparel 266 milligram Per 20 ML)
SalineDRUG

placebo injection of saline

Also known as: Injectable Saline
saline block

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients aged 18-80 years old
  • Patients undergoing non-emergent laparoscopic surgery with planned or continued admission for at least 1 night
  • Patients who receive fully laparoscopic procedures including ports up to 15mm, and any blunt dilation of port fascia or sharp extension of skin incisions for specimen extraction.

You may not qualify if:

  • Patients under 18 or over 80 years old
  • Patients who are pregnant
  • Patients who are unable to consent themselves
  • Patients who undergo an appendectomy for acute appendicitis
  • Patients who undergo emergent surgery
  • Patients who are converted to open procedure
  • Patients who receive concurrent neuraxial anesthesia (spinal, epidural, or indwelling pain pumps)
  • Patients who receive concurrent local anesthetic drips planned during or administered immediately after surgery
  • Patients who have a contraindication to local anesthetics (e.g. verified allergy, severe hepatic dysfunction)
  • Patients who use chronic narcotics

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Santa Barbara Cottage Hospital

Santa Barbara, California, 93105, United States

Location

MeSH Terms

Interventions

BupivacaineInjectionsSodium Chloride

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesDrug Administration RoutesDrug TherapyTherapeuticsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Marc Zerey, MD

    Cottage Hospital, Sansum Clinic

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Masking Details
single-blind study
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: prospective randomized control trial
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 2, 2018

First Posted

November 5, 2018

Study Start

February 4, 2019

Primary Completion

April 14, 2021

Study Completion

April 14, 2021

Last Updated

July 1, 2021

Record last verified: 2021-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)