Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

• ClinicalTrials.gov Identifier: NCT01075074
• Recruitment Status: Completed
• First Posted: February 24, 2010
• Results First Posted: April 3, 2012
• Last Update Posted: November 21, 2013
• Sponsor: Northwestern University
• Information provided by (Responsible Party): Gildasio De Oliveira, Northwestern University

Tracking Information

• First Submitted Date: February 23, 2010
• First Posted Date: February 24, 2010
• Results First Submitted Date: March 6, 2012
• Results First Posted Date: April 3, 2012
• Last Update Posted Date: November 21, 2013
• Study Start Date: August 2010
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: March 6, 2012)

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.

Original Primary Outcome Measures (submitted: February 23, 2010)

QoR40 on the day after surgery [ Time Frame: 24 hours after surgery ]

QoR40 on the day after surgery

Current Secondary Outcome Measures (submitted: March 6, 2012)

• 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.
• 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
• 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.

Original Secondary Outcome Measures (submitted: February 23, 2010)

PACU : opioid consumption [ Time Frame: Post Operative ]

PACU : opioid consumption

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery
• 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
• 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

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Care Provider, Investigator); Primary Purpose: Prevention

Condition

• 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.

Other Name: TAP block

Study Arms

• Active Comparator: Ropivacaine 0.05%
  Subject received a bilateral transversus abdominis plane block block using 15 cc of 0.5% ropivacaine on each side
  Intervention: Procedure: Transversus abdominis plane block
• Placebo Comparator: Normal Saline
  Subjects received a bilateral transversus abdominis plane block using 15 cc of sterile normal saline.
  Intervention: Procedure: Transversus abdominis plane block
• Active Comparator: Ropivacaine 0.25%
  Subjects received a bilateral transversus abdominis plane block using 15cc of 0.25% ropivacaine on each side
  Intervention: Procedure: Transversus abdominis plane block

Publications *

• 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.
• Wills VL, Hunt DR. Pain after laparoscopic cholecystectomy. Br J Surg. 2000 Mar;87(3):273-84. Review.
• 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.
• 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.
• 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.
• 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.
• 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.
• Turner GA, Chalkiadis G. Comparison of preoperative with postoperative lignocaine infiltration on postoperative analgesic requirements. Br J Anaesth. 1994 May;72(5):541-3.
• 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].
• Hebbard P, Fujiwara Y, Shibata Y, Royse C. Ultrasound-guided transversus abdominis plane (TAP) block. Anaesth Intensive Care. 2007 Aug;35(4):616-7.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: March 6, 2012): 75
• Original Estimated Enrollment (submitted: February 23, 2010): 50
• Actual Study Completion Date: March 2011
• Actual Primary Completion Date: March 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: Female

• Ages: 18 Years to 64 Years (Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01075074
• Other Study ID Numbers: STU00023475
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Responsible Party: Gildasio De Oliveira, Northwestern University
• Study Sponsor: Northwestern University
• Collaborators: Not Provided

Investigators

• Principal Investigator: Gildasio DeOliveira, MD; Northwestern University

• PRS Account: Northwestern University
• Verification Date: October 2013