Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

October 29, 2013 updated by: Gildasio De Oliveira, Northwestern University

The Effect of Pre Operative Transversus Abdominis Plane (TAP) Block in the Quality of Recovery of Patients Undergoing Outpatient Laparoscopic Gynecological Surgery: A Prospective, Randomized Blinded Study

The use of pre-operative transversus abdominis plane block will reduce pain after outpatient laparoscopic gynecological surgery and improve quality of recovery.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

75 subjects will be randomly allocated into 3 groups, using a computer generated table of random numbers. Group A (study group) will receive a bilateral TAP block using 15 cc of 0.5% ropivacaine on each side. Group B (control group) will receive 15 cc of sterile normal saline. Group C (study group 2) will receive a bilateral TAP block using 15 cc of 0.25% ropivacaine on each side.

Subjects will be premedicated with intravenous (IV) midazolam 0.04 mg/kg. Routine ASA monitors will be applied. Anesthesia will be induced with remifentanil infusion started at 0.1 mcg/kg/minute titrated to keep blood pressure within 20% of the baseline and propofol 1.0 -2.0 mg/kg. Tracheal intubation will be facilitated with rocuronium (0.6 mg/kg) or succinylcholine (1-2mg /kg). After induction, a bilateral TAP block will be performed in both groups, under ultrasound guidance with a transportable ultrasound device (SonoSite, Bothell, WA, USA) and a linear 6-13 MHz ultrasound transducer .Once the EOAM, IOAM and TAM are visualized at the level of the anterior axillary line between the 12th rib and the iliac crest, the puncture area and the ultrasound probe will be prepared in a sterile manner. Then the block will be performed with a 21 G 90mm StimuQuik needle( Arrow International, Reading, PA, USA ) utilizing an "in- plane" ultrasound-guided technique by three investigators (GDO ,AP). Once the tip of the needle is placed in the space between the IOAM and TAM, and after negative aspiration of blood, 15 cc of 0.5% ropivacaine, 15 cc of 0.25% ropivacaine or sterile normal saline will be administered under direct ultrasonographic guidance. The contralateral block will be performed in the same fashion. Anesthesia will be maintained with sevoflurane titrated to maintain a bispectral index (BIS) between 40-60 , remifentanil infusion started at 0.1mcg/kg/min titrated to keep blood pressure within 20 % of baseline values , and rocuronium that will be administered at the discretion of the anesthesiologist. Upon termination of the surgery, neuromuscular blockade will be antagonized with a combination of neostigmine 0.05mg/kg and glycopyrrolate 0.01 mg/kg. Subjects will also receive ketorolac 30 mg IV after discontinuation of remifentanil for postoperative pain control. Ondansetron 4 mg IV will be administered to prevent postoperative nausea and vomiting. Subjects will be assessed in the OR after extubation for their pain using a numerical rating scale and if pain greater than 4/10 they will receive hydromorphone(10 mcg /kg IV) Subjects will receive IV Hydromorphone in divided doses as needed to achieve a verbal rating score for pain <4 out of 10 In PACU.They will also receive metoclopramide (20 mg IV ) as rescue antiemetic in PACU. The primary and secondary outcomes will be assessed by an independent observer who will be blinded to group allocation (CA, AP, SA, YV, RJM and PF). A study team representative will telephone the participant at 24 hours, to complete the modified quality of recovery (QOR40) survey and ask the following:

  1. How much pain they are experiencing 0-10
  2. How and what kind of pain medications have been used since discharge.
  3. If they have had any nausea
  4. What kind of nausea relief medications have been used since discharge

Study Type

Interventional

Enrollment (Actual)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Northwestern Memorial Hospital

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 64 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age: 18-64 years
  • Surgery: Outpatient Gynecological laparoscopic surgery
  • ASA status: I and II
  • Fluent in English

Exclusion Criteria:

  • History of allergy to local anesthetics
  • History of chronic opioid use
  • Pregnant patients
  • BMI greater than 30

Drop-out criteria:

  • Patient or surgeon request
  • Complications related to the procedure

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Ropivacaine 0.05%
Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
Procedure: Transversus abdominis plane block
A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.
Other Names:
  • TAP block
Placebo Comparator: Normal Saline
Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
Procedure: Transversus abdominis plane block
A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.
Other Names:
  • TAP block
Active Comparator: Ropivacaine 0.25%
Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side
Procedure: Transversus abdominis plane block
A regional block performed in the transversus abdominis plane of the abdomen, used to provide anesthesia and analgesia for the abdominal region.
Other Names:
  • TAP block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery
Time Frame: 24 hours after surgery
The quality of recovery questionnaire (QOR40) is a 40 question assessment of patient recovery following surgery. It evaluates 5 domains of recovery: pain, emotional status, physical comfort, physical independence, and support. Each question is scores on a 1 to 5 Likert scale with total scores ranging for 40, representing poor recovery, to 200, representing outstanding recovery.
24 hours after surgery

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain Burden During Early Recovery From Anesthesia
Time Frame: Post Operative
Area under the numeric rating scale for pain versus time (min) curve during the post anesthesia care admission. Numeric rating scale 0 to 10 with 0 equals no pain and 10 equals worst pain imaginable.
Post Operative
Opioid Pain Medications Consumed During the First 24 Hours Post Surgery
Time Frame: 24 hours
Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge
24 hours
Time to Hospital Discharge Readiness
Time Frame: 24 hours
Elapsed time from post anesthesia care unit to readiness to hospital discharge. Assessment were made using the modified post anesthetic discharge scoring system. This assess 5 criteria: vital signs, activity and mental status, pain nausea and/or vomiting, surgical bleed, and intake and output. A score greater than or equal to 9 (on a 0 to 10 scale) is considered ready for discharge.
24 hours

Collaborators and Investigators

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

Sponsor

Northwestern University

Investigators

  • Principal Investigator: Gildasio DeOliveira, MD, Northwestern University

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

August 1, 2010

Primary Completion (Actual)

March 1, 2011

Study Completion (Actual)

March 1, 2011

Study Registration Dates

First Submitted

February 23, 2010

First Submitted That Met QC Criteria

February 23, 2010

First Posted (Estimate)

February 24, 2010

Study Record Updates

Last Update Posted (Estimate)

November 21, 2013

Last Update Submitted That Met QC Criteria

October 29, 2013

Last Verified

October 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • STU00023475

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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