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
  Purpose

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.


Condition Intervention
Laparoscopic Cholecystectomy
Postoperative Pain
Abdominal Muscles
Nerve Block
Procedure: Ultrasound guided subcostal TAP block
Procedure: Placebo Ultrasound guided subcostal TAP block

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial

Resource links provided by NLM:


Further study details as provided by Soonchunhyang University Hospital:

Primary Outcome Measures:
  • Numerical Rating Scale (NRS) 15 min after entering recovery room [ Time Frame: 15 min after entering recovery room ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 50
Study Start Date: July 2012
Estimated Study Completion Date: March 2013
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Placebo Comparator: Control
Control group receiving saline instead of ropivacaine
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.
Experimental: TAP
TAP group receiving ropivacaine total of 150 mg at TAP under US
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.

  Eligibility

Ages Eligible for Study:   20 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01595165

Contacts
Contact: Sang-Hyun Kim, M.D., Ph.D. 82-32-621-5328 skim@schmc.ac.kr

Locations
Korea, Republic of
Sang-Hyun Kim Recruiting
Bucheon, Gyeonggi, Korea, Republic of, 420767
Contact: Sang-Hyun Kim, M.D., Ph.D.    82-32-621-5328    skim@schmc.ac.kr   
Sponsors and Collaborators
Soonchunhyang University Hospital
Investigators
Principal Investigator: Sang-Hyun Kim, M.D., Ph.D. Soonchunhyang University Hospital
  More Information

No publications provided

Responsible Party: Kim Sang-Hyun, Associate professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01595165     History of Changes
Other Study ID Numbers: schbcanesthesia
Study First Received: May 7, 2012
Last Updated: July 5, 2012
Health Authority: Korea: Institutional Review Board

Keywords provided by Soonchunhyang University Hospital:
laparoscopic cholecystectomy
ultrasound
transversus abdominis plane block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Pathologic Processes
Postoperative Complications
Signs and Symptoms

ClinicalTrials.gov processed this record on October 30, 2014