Transversus Abdominal Plane Block at Total Laparoscopic Hysterectomy: Effect on Quality of Recovery (TAP)

October 5, 2018 updated by: Robert Pollard, MetroHealth Medical Center

Randomized Trial of Transversus Abdominal Plane (TAP) Block at Total Laparoscopic Hysterectomy: Effect of Regional Analgesia on Quality of Recovery

The Transversus Abdominal Plane (TAP) block has been used with good success to decrease postoperative pain following laparatomy. If the TAP block provides any improvement in the quality of recovery following laparoscopic hysterectomy, it could decrease the need for postoperative narcotics and allow for more outpatient hysterectomy procedures.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

56

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Any patient undergoing laparoscopic hysterectomy
  • Age ranges 18-80
  • Reading literacy
  • English speaking
  • Able to give informed consent

Exclusion Criteria:

  • History of relevant drug allergy
  • Chronic opioid users who may have tolerance to pain medications
  • Inability to understand written consent forms or give consent
  • Age less than 18 or over 80
  • Any conversion to open surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TAP Block
20mL of 0.25% Ropivacaine with Epinephrine 1:200,000 is injected into bilateral transversus abdominal planes under ultrasound guidance.
Drug: TAP Block
Bilateral transversus abdominal plane injection under ultrasound guidance, done at conclusion of hysterectomy procedure, prior to emergence from general anesthesia
Other Names:
  • Ropivacaine with Epinephrine
No Intervention: No Block
Patients randomized to this arm have band aids applied to sites on lateral abdomen without injection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Quality of Recovery Questionnaire (QoR-40) on Postop Day #1 or #2
Time Frame: Postop Day #1 or Day #2
40 question survey completed on paper or by telephone on post-operative day #1 or #2, designed to measure health status after surgery and anesthesia. Scale ranges from 40 (extremely poor qualify of recovery) to 200 (excellent quality of recovery).
Postop Day #1 or Day #2

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Narcotic Use
Time Frame: Postop Day #0 and Day #1
narcotic use in mg of Morphine will be recorded
Postop Day #0 and Day #1
Visual Analog Scale (VAS) for Pain
Time Frame: 2 and 24 hours post operative
visual analogue scales for pain will be completed on post-operative day #0 and #1, pain is assessed on a 10-point visual analogue scale (0 = no pain; 1 to 3 = mild; 4 to 6 = moderate pain; 7 to 10 = severe pain.)
2 and 24 hours post operative
Intraoperative Time
Time Frame: the total intraoperative time in minutes
The total time in the operating room will be recorded to see if there is a difference between groups.
the total intraoperative time in minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetroHealth Medical Center

Investigators

  • Principal Investigator: Sarah M Kane, MD, MetroHealth Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2011

Primary Completion (Actual)

September 1, 2011

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

November 22, 2011

First Submitted That Met QC Criteria

November 22, 2011

First Posted (Estimate)

November 24, 2011

Study Record Updates

Last Update Posted (Actual)

October 11, 2018

Last Update Submitted That Met QC Criteria

October 5, 2018

Last Verified

October 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IRB10-01517

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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