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

History of Changes

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:

MedlinePlus related topics: Ultrasound

U.S. FDA Resources

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 (Adult)
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


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 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

ClinicalTrials.gov processed this record on September 30, 2016

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