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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01444924
Other study ID # 2011-0274
Secondary ID CO117012011-0274
Status Completed
Phase Phase 2
First received
Last updated
Start date September 2011
Est. completion date March 2013

Study information

Verified date March 2018
Source University of Wisconsin, Madison
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 75
Est. completion date March 2013
Est. primary completion date February 2013
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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.

Study Design


Intervention

Drug:
Bupivicaine
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
Placebo
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.

Locations

Country Name City State
United States University of Wisconsin School of Medicine and Public Health Madison Wisconsin

Sponsors (1)

Lead Sponsor Collaborator
University of Wisconsin, Madison

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 24 Hour Post Operative Opioid Consumption, Converted to Intravenous Morphine Equivalents 24 hours
Secondary Pain Scores Pain scores by the Visual Analog Scale (VAS) [0-5, where 0 is no pain and 5 is extreme] and Wisconsin Brief Pain Inventory (BPI) [where 0 is no pain and 10 is the most painful], will be collected 3 times post-operatively (once the day of surgery (at least 2 hours post-op) and both the morning and afternoon/evening on post-operative day #1). Pain scores will be analyzed individually using the chi-squared test and linear regression. All statistical calculations used a two-sided significance level of 0.05 and were calculated using the R Project for Statistical Computing. VAS and BPI scores for each subject were averaged to provide a resultant VAS and BPI score. from 2 hours post-op to the afternoon/evening of post-op day #1
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