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Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery

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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:
Information provided by (Responsible Party):
Gildasio De Oliveira, Northwestern University

Tracking Information
First Submitted Date  ICMJE February 23, 2010
First Posted Date  ICMJE February 24, 2010
Results First Submitted Date  ICMJE March 6, 2012
Results First Posted Date  ICMJE April 3, 2012
Last Update Posted Date November 21, 2013
Study Start Date  ICMJE August 2010
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (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  ICMJE
 (submitted: February 23, 2010)
QoR40 on the day after surgery [ Time Frame: 24 hours after surgery ]
QoR40 on the day after surgery
Change History
Current Secondary Outcome Measures  ICMJE
 (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  ICMJE
 (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  ICMJE Pre Operative Transversus Abdominis Plane Block Laparoscopic Gynecological Surgery
Official Title  ICMJE 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  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Prevention
Condition  ICMJE
  • Pain
  • Surgery
Intervention  ICMJE 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  ICMJE
  • 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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 6, 2012)
75
Original Estimated Enrollment  ICMJE
 (submitted: February 23, 2010)
50
Actual Study Completion Date  ICMJE March 2011
Actual Primary Completion Date March 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 64 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01075074
Other Study ID Numbers  ICMJE STU00023475
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gildasio De Oliveira, Northwestern University
Study Sponsor  ICMJE Northwestern University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Gildasio DeOliveira, MD Northwestern University
PRS Account Northwestern University
Verification Date October 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP