Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

NCT01595165 | Unknown DMC

• 1 other identifier: schbcanesthesia
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Laparoscopic Cholecystectomy; Postoperative Pain; Abdominal Muscles; Nerve Block

Keywords

laparoscopic cholecystectomy; ultrasound; transversus abdominis plane block

Outcome Measures

Primary Outcomes (1)

• Numerical Rating Scale (NRS) 15 min after entering recovery room

  15 min after entering recovery room

Secondary Outcomes (4)

• Fentanyl consumption at recovery room

  Up to 3 hours until discharge from recovery room

• Recovery room stay

  Up to 3 hours from entering recovery room to discharge

• Incidence of postoperative nausea and vomiting (PONV)

  Up to 3 hours during recovery room stay

• NRS at 4h, 24h, and 48 h after surgery

  4h, 24h, and 48 h after surgery

Study Arms (2)

Control

PLACEBO COMPARATOR

Control group receiving saline instead of ropivacaine

Procedure: Placebo Ultrasound guided subcostal TAP block

TAP

EXPERIMENTAL

TAP group receiving ropivacaine total of 150 mg at TAP under US

Procedure: Ultrasound guided subcostal TAP block

Interventions

Ultrasound guided subcostal TAP block PROCEDURE

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.

TAP

Placebo Ultrasound guided subcostal TAP block PROCEDURE

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.

Control

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA I-II
• Age 20-65 patients scheduled elective laparoscopic cholecystectomy

You may not qualify if:

• Patient refusal
• Allergy to ropivacaine
• Coagulopathy
• Morbid obesity (BMI\>35 kg/m2)
• Previous abdominal surgery.

Sponsors & Collaborators

• Soonchunhyang University Hospital: lead

Study Sites (1)

Sang-Hyun Kim

Bucheon-si, Gyeonggi-do, 420767, South Korea

RECRUITING

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Sang-Hyun Kim, M.D., Ph.D.

  Soonchunhyang University Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sang-Hyun Kim, M.D., Ph.D.

CONTACT

82-32-621-5328; skim@schmc.ac.kr

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate professor

Study Record Dates

• First Submitted: May 7, 2012
• First Posted: May 9, 2012
• Study Start: July 1, 2012
• Primary Completion: December 1, 2012
• Study Completion: March 1, 2013
• Last Updated: July 9, 2012

Record last verified: 2012-07

Locations

KR (1)