Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

Not Applicable

Completed

• Conditions: Pain; Surgery
• Interventions: Procedure: Transversus abdominis plane block

• Registration Number: NCT01075074
• Lead Sponsor: Northwestern University

Brief Summary

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

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

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2010-02-23
• Study First Submitted QC: 2010-02-23
• Study First Posted: 2010-02-24
• Study Start: 2010-08
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Results First Submitted: 2012-03-06
• Results First Submitted QC: 2012-03-06
• Results First Posted: 2012-04-03
• Status Verified: 2013-10
• Last Update Submitted: 2013-10-29
• Last Update Posted: 2013-11-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 75

Inclusion Criteria

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ropivacaine 0.05%	Transversus abdominis plane block	Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
Normal Saline	Transversus abdominis plane block	Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
Ropivacaine 0.25%	Transversus abdominis plane block	Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side

Primary Outcome Measures

Name	Time	Method
The Quality of Recovery Questionnaire (QoR40) on the Day (24 Hours) After Surgery	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.

Secondary Outcome Measures

Name	Time	Method
Pain Burden During Early Recovery From Anesthesia	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.
Opioid Pain Medications Consumed During the First 24 Hours Post Surgery	24 hours	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	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.

Trial Locations

Locations (1)

Northwestern Memorial Hospital; 🇺🇸 Chicago, Illinois, United States