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Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified July 2012 by Soonchunhyang University Hospital.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Kim Sang-Hyun, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier:
NCT01595165
First received: May 7, 2012
Last updated: July 5, 2012
Last verified: July 2012

May 7, 2012
July 5, 2012
July 2012
December 2012   (final data collection date for primary outcome measure)
Numerical Rating Scale (NRS) 15 min after entering recovery room [ Time Frame: 15 min after entering recovery room ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01595165 on ClinicalTrials.gov Archive Site
  • Fentanyl consumption at recovery room [ Time Frame: Up to 3 hours until discharge from recovery room ] [ Designated as safety issue: No ]
  • Recovery room stay [ Time Frame: Up to 3 hours from entering recovery room to discharge ] [ Designated as safety issue: No ]
  • Incidence of postoperative nausea and vomiting (PONV) [ Time Frame: Up to 3 hours during recovery room stay ] [ Designated as safety issue: No ]
  • NRS at 4h, 24h, and 48 h after surgery [ Time Frame: 4h, 24h, and 48 h after surgery ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial

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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
  • Laparoscopic Cholecystectomy
  • Postoperative Pain
  • Abdominal Muscles
  • Nerve Block
  • 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.
  • 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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
50
March 2013
December 2012   (final data collection date for primary outcome measure)

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.
Both
20 Years to 65 Years
No
Contact: Sang-Hyun Kim, M.D., Ph.D. 82-32-621-5328 skim@schmc.ac.kr
Korea, Republic of
 
NCT01595165
schbcanesthesia
Yes
Kim Sang-Hyun, Soonchunhyang University Hospital
Soonchunhyang University Hospital
Not Provided
Principal Investigator: Sang-Hyun Kim, M.D., Ph.D. Soonchunhyang University Hospital
Soonchunhyang University Hospital
July 2012

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