Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University
ClinicalTrials.gov Identifier:
NCT01075074
First received: February 23, 2010
Last updated: October 29, 2013
Last verified: October 2013
  Purpose

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


Condition Intervention
Pain
Surgery
Procedure: Transversus abdominis plane block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Prevention
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Northwestern University:

Primary Outcome Measures:
  • The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery [ Time Frame: 24 hours after surgery ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Pain Burden During Early Recovery From Anesthesia [ Time Frame: Post Operative ] [ Designated as safety issue: No ]
    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.

  • Opioid Pain Medications Consumed During the First 24 Hours Post Surgery [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge

  • Time to Hospital Discharge Readiness [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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.


Enrollment: 75
Study Start Date: August 2010
Study Completion Date: March 2011
Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: 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 Name: 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 Name: TAP block

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
  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01075074

Locations
United States, Illinois
Northwestern Memorial Hospital
Chicago, Illinois, United States, 60611
Sponsors and Collaborators
Northwestern University
Investigators
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
  More Information

Publications:

Responsible Party: Gildasio De Oliveira, Gildasio De Oliveira, M.D. Principal Investigator, Northwestern University
ClinicalTrials.gov Identifier: NCT01075074     History of Changes
Other Study ID Numbers: STU00023475
Study First Received: February 23, 2010
Results First Received: March 6, 2012
Last Updated: October 29, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Northwestern University:
Pain
TAP block
Laparoscopic
Gynecologic

Additional relevant MeSH terms:
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Pharmacologic Actions
Sensory System Agents
Peripheral Nervous System Agents
Central Nervous System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on April 17, 2014