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Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial


Phase 2
18 Years
N/A
Open (Enrolling)
Female
Gynecologic Cancer, Post-operative Pain

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Trial Information

Transversus Abdominis Plane Blocks for Patients Undergoing Robotic Gynecologic Oncology Surgery: A Prospective Randomized, Double-blind, Placebo-controlled Trial


Inclusion Criteria:



- 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.

Exclusion Criteria:

- 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.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Supportive Care

Outcome Measure:

24 hour post operative opioid consumption, converted to intravenous morphine equivalents

Outcome Time Frame:

24 hours

Safety Issue:

No

Principal Investigator

David M Kushner, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University of Wisconsin, Madison

Authority:

United States: Institutional Review Board

Study ID:

2011-0274

NCT ID:

NCT01444924

Start Date:

September 2011

Completion Date:

October 2013

Related Keywords:

  • Gynecologic Cancer
  • Post-operative Pain
  • Pain control
  • Gynecologic Oncology
  • Surgery
  • Pain, Postoperative

Name

Location
University of Wisconsin School of Medicine and Public Health Madison, Wisconsin  53792-5666