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Clinical Trials/NCT01595165
NCT01595165UnknownNot Applicable

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

Soonchunhyang University Hospital1 site in 1 country50 target enrollmentStarted: July 1, 2012Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Enrollment
50
Locations
1
Primary Endpoint
Numerical Rating Scale (NRS) 15 min after entering recovery room

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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.

Arms & Interventions

Control

Placebo Comparator

Control group receiving saline instead of ropivacaine

Intervention: Placebo Ultrasound guided subcostal TAP block (Procedure)

TAP

Experimental

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

Intervention: Ultrasound guided subcostal TAP block (Procedure)

Outcomes

Primary Outcomes

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

Time Frame: 15 min after entering recovery room

Secondary Outcomes

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

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Kim Sang-Hyun

Associate professor

Soonchunhyang University Hospital

Study Sites (1)

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