Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01075074
• Other study ID #: STU00023475
• Status: Completed
• Phase: N/A
• First received: February 23, 2010
• Last updated: October 29, 2013
• Start date: August 2010
• Est. completion date: March 2011

Study information

• Verified date: October 2013
• Source: Northwestern University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 64 Years

Eligibility

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 Design

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

Related Conditions & MeSH terms

• Pain
• Surgery

Intervention

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.

Locations

Country	Name	City	State
United States	Northwestern Memorial Hospital	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Northwestern University

Country where clinical trial is conducted

United States, 

References & Publications (10)

Buvanendran A, Kroin JS. Multimodal analgesia for controlling acute postoperative pain. Curr Opin Anaesthesiol. 2009 Oct;22(5):588-93. doi: 10.1097/ACO.0b013e328330373a. Review. — View Citation

Goldstein A, Grimault P, Henique A, Keller M, Fortin A, Darai E. Preventing postoperative pain by local anesthetic instillation after laparoscopic gynecologic surgery: a placebo-controlled comparison of bupivacaine and ropivacaine. Anesth Analg. 2000 Aug;91(2):403-7. — View Citation

Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7. — View Citation

Keita H, Benifla JL, Le Bouar V, Porcher R, Wachowska B, Bedairia K, Mantz J, Desmonts JM. Prophylactic ip injection of bupivacaine and/or morphine does not improve postoperative analgesia after laparoscopic gynecologic surgery. Can J Anaesth. 2003 Apr;50(4):362-7. — View Citation

Lovatsis D, José JB, Tufman A, Drutz HP, Murphy K. Assessment of patient satisfaction with postoperative pain management after ambulatory gynaecologic laparoscopy. J Obstet Gynaecol Can. 2007 Aug;29(8):664-7. — View Citation

Møiniche S, Mikkelsen S, Wetterslev J, Dahl JB. A qualitative systematic review of incisional local anaesthesia for postoperative pain relief after abdominal operations. Br J Anaesth. 1998 Sep;81(3):377-83. — View Citation

O'Donnell BD, McDonnell JG, McShane AJ. The transversus abdominis plane (TAP) block in open retropubic prostatectomy. Reg Anesth Pain Med. 2006 Jan-Feb;31(1):91. Erratum in: Reg Anesth Pain Med. 2006 May-Jun;31(3):286. McDonnell, John G [added]; McShane, Alan J [added]. — View Citation

Shaw IC, Stevens J, Krishnamurthy S. The influence of intraperitoneal bupivacaine on pain following major laparoscopic gynaecological procedures. Anaesthesia. 2001 Nov;56(11):1041-4. — View Citation

Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3. — View Citation

Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Quality of Recovery Questionnaire (QoR40) on the Day (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	No
Secondary	Pain Burden During Early Recovery From Anesthesia	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	No
Secondary	Opioid Pain Medications Consumed During the First 24 Hours Post Surgery	Opioid consumption in oral morphine equivalents taken by the subject for pain during the first 24 hours post hospital discharge	24 hours	No
Secondary	Time to Hospital Discharge Readiness	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	No