NCT01444924

Brief Summary

This study is a single-center, randomized, placebo-controlled, double-blind clinical trial. The purpose of this study is to evaluate the impact of pre-operative transverses abdominis plane (TAP) blocks on post-operative analgesia in patients undergoing robotic surgery for gynecologic cancers.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Sep 2011

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2011

Completed
28 days until next milestone

First Submitted

Initial submission to the registry

September 29, 2011

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 3, 2011

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2013

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2013

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

September 23, 2014

Completed
Last Updated

November 27, 2019

Status Verified

March 1, 2018

Enrollment Period

1.4 years

First QC Date

September 29, 2011

Results QC Date

June 6, 2014

Last Update Submit

November 14, 2019

Conditions

Gynecologic CancerPost-operative Pain

Keywords

Pain controlGynecologic OncologySurgery

Outcome Measures

Primary Outcomes (1)

  • 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents

    24 hours

Secondary Outcomes (1)

  • Pain Scores

    from 2 hours post-op to the afternoon/evening of post-op day #1

Study Arms (2)

Bupivicaine

EXPERIMENTAL

TAP block with bupivicaine/epinephrine placed prior to surgery.

Drug: Bupivicaine

Placebo

PLACEBO COMPARATOR

TAP block with placebo placed prior to surgery

Drug: Placebo

Interventions

BupivicaineDRUG

The TAP block will be placed using a standardized ultrasound-guided approach. Subjects assigned to the study group will have an injection of 30 mL 0.25% bupivacaine, a local anesthetic with 3 mcg/mL of epinephrine, placed into the plane between the internal oblique and the transversus abdominis

Bupivicaine
PlaceboDRUG

The placebo block will be placed in a similar manner, using a standardized ultrasound-guided approach. The placebo injection will consist of 30 mL sterile, preservative-free saline.

Placebo

Eligibility Criteria

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

You may qualify if:

  • Patients undergoing robotic-assisted surgery under the care of the Division of Gynecologic Oncology at UWHC.
  • Patients must be ≥18 years old.
  • Patients must be English speaking.
  • Patients must have the ability to understand visual and verbal pain scales.
  • ASA physical status 1-3.

You may not qualify if:

  • Known allergy to local anesthetics.
  • Immunocompromised.
  • Known history of opioid dependence, as available within the medical record and standard of care pre-operative work-up.
  • Known history of chronic pain disorders.
  • Pregnancy or lactation.
  • Patient is a prisoner or incarcerated.
  • Significant liver disease that would inhibit prescription of opioids.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Wisconsin School of Medicine and Public Health

Madison, Wisconsin, 53792, United States

Location

Related Links

MeSH Terms

Conditions

Pain, PostoperativeAgnosia

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and SymptomsPerceptual DisordersNeurobehavioral ManifestationsNervous System Diseases

Limitations and Caveats

Unilateral placement of block may decrease overall effectiveness. Sample size was small, from single institution, and encompassed a variety of diagnoses and procedures. Analysis also included intraoperative medications.

Results Point of Contact

Title
Dr. David Kushner
Organization
University of Wisconsin Hospitals and Clinics
dmkushner@facstaff.wisc.edu
608-263-0796

Study Officials

  • David M Kushner, MD

    University of Wisconsin, Madison

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 29, 2011

First Posted

October 3, 2011

Study Start

September 1, 2011

Primary Completion

February 1, 2013

Study Completion

March 1, 2013

Last Updated

November 27, 2019

Results First Posted

September 23, 2014

Record last verified: 2018-03

Locations

US(1)