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Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

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ClinicalTrials.gov Identifier: NCT01595165
Recruitment Status : Unknown
Verified July 2012 by Kim Sang-Hyun, Soonchunhyang University Hospital.
Recruitment status was:  Recruiting
First Posted : May 9, 2012
Last Update Posted : July 9, 2012
Sponsor:
Information provided by (Responsible Party):
Kim Sang-Hyun, Soonchunhyang University Hospital

Tracking Information
First Submitted Date  ICMJE May 7, 2012
First Posted Date  ICMJE May 9, 2012
Last Update Posted Date July 9, 2012
Study Start Date  ICMJE July 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
Numerical Rating Scale (NRS) 15 min after entering recovery room [ Time Frame: 15 min after entering recovery room ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: May 8, 2012)
  • Fentanyl consumption at recovery room [ Time Frame: Up to 3 hours until discharge from recovery room ]
  • Recovery room stay [ Time Frame: Up to 3 hours from entering recovery room to discharge ]
  • Incidence of postoperative nausea and vomiting (PONV) [ Time Frame: Up to 3 hours during recovery room stay ]
  • NRS at 4h, 24h, and 48 h after surgery [ Time Frame: 4h, 24h, and 48 h after surgery ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
Official Title  ICMJE Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial
Brief Summary Transversus abdominis plane (TAP) block has gained popularity for the control of postoperative pain in various surgeries. Three studies showed inconsistent result on pain control after TAP block in laparoscopic cholecystectomy. The TAP technique used in these studies was classic ultrasound guided TAP block. Besides periumbilical incision, sub-xiphoid incision is usually made during laparoscopic cholecystectomy. As typical posterior TAP rarely extend above T8, the investigators undergo subcostal TAP block for this type of surgery. The investigators are going to investigate the effect of subcostal TAP on early postoperative pain after laparoscopic cholecystectomy.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Laparoscopic Cholecystectomy
  • Postoperative Pain
  • Abdominal Muscles
  • Nerve Block
Intervention  ICMJE
  • Procedure: Ultrasound guided subcostal TAP block
    Under ultrasound guidance0.375% ropivacaine 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
  • Procedure: Placebo Ultrasound guided subcostal TAP block
    Under ultrasound guidance saline 10 ml will be injected between rectus abdominis and transverse abdominis and same study solution will be injected at subcostal transversus abdominis plane. This block will be done bilaterally.
Study Arms  ICMJE
  • Placebo Comparator: Control
    Control group receiving saline instead of ropivacaine
    Intervention: Procedure: Placebo Ultrasound guided subcostal TAP block
  • Experimental: TAP
    TAP group receiving ropivacaine total of 150 mg at TAP under US
    Intervention: Procedure: Ultrasound guided subcostal TAP block
Publications * Not Provided

*   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 Unknown status
Estimated Enrollment  ICMJE
 (submitted: May 8, 2012)
50
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2013
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • ASA I-II
  • Age 20-65 patients scheduled elective laparoscopic cholecystectomy

Exclusion Criteria:

  • Patient refusal
  • Allergy to ropivacaine
  • Coagulopathy
  • Morbid obesity (BMI>35 kg/m2)
  • Previous abdominal surgery.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Korea, Republic of
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01595165
Other Study ID Numbers  ICMJE schbcanesthesia
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Kim Sang-Hyun, Soonchunhyang University Hospital
Study Sponsor  ICMJE Soonchunhyang University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sang-Hyun Kim, M.D., Ph.D. Soonchunhyang University Hospital
PRS Account Soonchunhyang University Hospital
Verification Date July 2012

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