ClinicalTrials.gov
ClinicalTrials.gov Menu

Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
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

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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Postoperative Pain Abdominal Muscles Nerve Block Procedure: Ultrasound guided subcostal TAP block Procedure: Placebo Ultrasound guided subcostal TAP block Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : July 2012
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : March 2013

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. Numerical Rating Scale (NRS) 15 min after entering recovery room [ Time Frame: 15 min after entering recovery room ]

Secondary Outcome Measures :
  1. Fentanyl consumption at recovery room [ Time Frame: Up to 3 hours until discharge from recovery room ]
  2. Recovery room stay [ Time Frame: Up to 3 hours from entering recovery room to discharge ]
  3. Incidence of postoperative nausea and vomiting (PONV) [ Time Frame: Up to 3 hours during recovery room stay ]
  4. NRS at 4h, 24h, and 48 h after surgery [ Time Frame: 4h, 24h, and 48 h after surgery ]


Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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

Responsible Party: Kim Sang-Hyun, Associate professor, Soonchunhyang University Hospital
ClinicalTrials.gov Identifier: NCT01595165     History of Changes
Other Study ID Numbers: schbcanesthesia
First Posted: May 9, 2012    Key Record Dates
Last Update Posted: July 9, 2012
Last Verified: July 2012

Keywords provided by Kim Sang-Hyun, Soonchunhyang University Hospital:
laparoscopic cholecystectomy
ultrasound
transversus abdominis plane block

Additional relevant MeSH terms:
Pain, Postoperative
Pain
Neurologic Manifestations
Nervous System Diseases
Postoperative Complications
Pathologic Processes
Signs and Symptoms
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents