Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

Postoperative Pain Clinical Trial

Official title:

Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01595165
• Other study ID #: schbcanesthesia
• Status: Recruiting
• Phase: N/A
• First received: May 7, 2012
• Last updated: July 5, 2012
• Start date: July 2012
• Est. completion date: March 2013

Study information

• Verified date: July 2012
• Source: Soonchunhyang University Hospital
• Contact: Sang-Hyun Kim, M.D., Ph.D.
• Phone: 82-32-621-5328
• Email: skim[@]schmc.ac.kr
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: March 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 65 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Abdominal Muscles
• Laparoscopic Cholecystectomy
• Nerve Block
• Pain, Postoperative
• Postoperative Pain

Intervention

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.
• 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.

Locations

Country	Name	City	State
Korea, Republic of	Sang-Hyun Kim	Bucheon	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
Soonchunhyang University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numerical Rating Scale (NRS) 15 min after entering recovery room		15 min after entering recovery room	No
Secondary	Fentanyl consumption at recovery room		Up to 3 hours until discharge from recovery room	No
Secondary	Recovery room stay		Up to 3 hours from entering recovery room to discharge	No
Secondary	Incidence of postoperative nausea and vomiting (PONV)		Up to 3 hours during recovery room stay	No
Secondary	NRS at 4h, 24h, and 48 h after surgery		4h, 24h, and 48 h after surgery	No