NCT02400645

Brief Summary

In this randomized, controlled, double-blinded trial we plan to evaluate post-operative pain relief after laparoscopic-assisted Transversus Abdominis Plane (TAP) block using liposomal bupivacaine plus bupivacaine versus pre-incisional would infiltration with bupivacaine in patients undergoing Total laparoscopic or robotic assisted laparoscopic hysterectomy.

Trial Health

55
Monitor

Trial Health Score

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

Enrollment
69

participants targeted

Target at P50-P75 for phase_1 postoperative-pain

Timeline
Completed

Started Mar 2015

Typical duration for phase_1 postoperative-pain

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

Study Start

First participant enrolled

March 1, 2015

Completed
10 days until next milestone

First Submitted

Initial submission to the registry

March 11, 2015

Completed
16 days until next milestone

First Posted

Study publicly available on registry

March 27, 2015

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2016

Completed
Last Updated

April 28, 2020

Status Verified

March 1, 2015

Enrollment Period

1.2 years

First QC Date

March 11, 2015

Last Update Submit

April 27, 2020

Conditions

Postoperative Pain

Keywords

laparoscopic hysterectomyrobotic assisted hysterectomy

Outcome Measures

Primary Outcomes (1)

  • Visual Analog pain scores (VAS)

    1. Postoperative pain at 1 hour and 2 hours after arrival to recovery using Visual Analog Pain Scores (VAS) 2. VAS: 0 (no pain) TO 10 (worst possible pain)

    Two hours

Secondary Outcomes (2)

  • Narcotic pain medication usage

    2 hours postoperative

  • Narcotic pain medication following surgery

    1 week

Other Outcomes (1)

  • Overall Benefit of Anesthesia scores (OBAS) on postoperative days 1,2 and 7

    One week

Study Arms (2)

Group A: pre-incisional bupivacaine

ACTIVE COMPARATOR

Intervention: Pre-incisional wound infiltration with bupivacaine plain 0.25%. Ketorolac 30mg IV will be given following surgical procedure.

Procedure: Pre-incisional wound infiltrationDrug: BupivacaineDrug: Ketorolac

Group B: laparoscope to place TAP block

ACTIVE COMPARATOR

Intervention: laparoscope to place TAP block with liposomal bupivacaine and bupivacaine plain 0.25%. Ketorolac 30 mg IV will be given following surgical procedure.

Procedure: Laparoscope to place TAP block with liposomal bupivacaineDrug: Liposomal bupivacaineDrug: BupivacaineDrug: Ketorolac

Interventions

Pre-incisional wound infiltrationPROCEDURE

Intraoperative: Pre-incisional bupivacaine 0.25% up to 20 cc divided dose for trocar incisions

Group A: pre-incisional bupivacaine
Laparoscope to place TAP block with liposomal bupivacainePROCEDURE

Intraoperative: Laparoscopic TAP block with Liposomal bupivacaine and bupivacaine 0.25%

Also known as: Laparoscopic TAP block with Liposomal bupivacaine
Group B: laparoscope to place TAP block
Liposomal bupivacaineDRUG

Use of Liposomal bupivacaine in laparoscopic TAP block

Also known as: Exparel
Group B: laparoscope to place TAP block
BupivacaineDRUG

20 cc Bupivacaine 0.25% plain will be used for either pre-incisional injection or added to laparoscopic TAP block solution.

Also known as: Marcaine
Group A: pre-incisional bupivacaineGroup B: laparoscope to place TAP block
KetorolacDRUG

Ketorolac 30mg to be given IV at end of surgical procedure unless contraindicated.

Also known as: Toradol
Group A: pre-incisional bupivacaineGroup B: laparoscope to place TAP block

Eligibility Criteria

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

You may qualify if:

  • ASA physical status 1-3,
  • Scheduled for laparoscopic or robotic assisted laparoscopic hysterectomy,
  • Able to participate personally or by legal representation in informed consent

You may not qualify if:

  • History of relevant allergy to the study drugs (Bupivacaine),
  • Chronic opioid use or drug abuse history,
  • Inability to understand the study protocol,
  • Refusal to provide written consent,
  • Soft tissue infection of the abdominal wall and skin

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

BupivacaineKetorolacKetorolac Tromethamine

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesIndomethacinIndolesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Shanti I Mohling, MD

    University of Tennessee

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 11, 2015

First Posted

March 27, 2015

Study Start

March 1, 2015

Primary Completion

May 1, 2016

Study Completion

May 1, 2016

Last Updated

April 28, 2020

Record last verified: 2015-03