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Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

Primary Purpose

Laparoscopic Cholecystectomy, Postoperative Pain, Abdominal Muscles

Status
Unknown status
Phase
Not Applicable
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Ultrasound guided subcostal TAP block
Placebo Ultrasound guided subcostal TAP block
Sponsored by
Soonchunhyang University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Cholecystectomy focused on measuring laparoscopic cholecystectomy, ultrasound, transversus abdominis plane block

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Sang-Hyun KimRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control

TAP

Arm Description

Control group receiving saline instead of ropivacaine

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Fentanyl consumption at recovery room
Recovery room stay
Incidence of postoperative nausea and vomiting (PONV)
NRS at 4h, 24h, and 48 h after surgery

Full Information

First Posted
May 7, 2012
Last Updated
July 5, 2012
Sponsor
Soonchunhyang University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT01595165
Brief Title
Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy
Official Title
Effect of Subcostal Transversus Abdominis Plane Block on Early Postoperative Pain in Laparoscopic Cholecystectomy: Randomized, Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
July 2012
Overall Recruitment Status
Unknown status
Study Start Date
July 2012 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
March 2013 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Soonchunhyang University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Postoperative Pain, Abdominal Muscles, Nerve Block
Keywords
laparoscopic cholecystectomy, ultrasound, transversus abdominis plane block

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Control
Arm Type
Placebo Comparator
Arm Description
Control group receiving saline instead of ropivacaine
Arm Title
TAP
Arm Type
Experimental
Arm Description
TAP group receiving ropivacaine total of 150 mg at TAP under US
Intervention Type
Procedure
Intervention Name(s)
Ultrasound guided subcostal TAP block
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Placebo Ultrasound guided subcostal TAP block
Intervention Description
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.
Primary Outcome Measure Information:
Title
Numerical Rating Scale (NRS) 15 min after entering recovery room
Time Frame
15 min after entering recovery room
Secondary Outcome Measure Information:
Title
Fentanyl consumption at recovery room
Time Frame
Up to 3 hours until discharge from recovery room
Title
Recovery room stay
Time Frame
Up to 3 hours from entering recovery room to discharge
Title
Incidence of postoperative nausea and vomiting (PONV)
Time Frame
Up to 3 hours during recovery room stay
Title
NRS at 4h, 24h, and 48 h after surgery
Time Frame
4h, 24h, and 48 h after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sang-Hyun Kim, M.D., Ph.D.
Phone
82-32-621-5328
Email
skim@schmc.ac.kr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Kim, M.D., Ph.D.
Organizational Affiliation
Soonchunhyang University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sang-Hyun Kim
City
Bucheon
State/Province
Gyeonggi
ZIP/Postal Code
420767
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sang-Hyun Kim, M.D., Ph.D.
Phone
82-32-621-5328
Email
skim@schmc.ac.kr

12. IPD Sharing Statement

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Transversus Abdominis Plane Block and Postoperative Pain After Laparoscopic Cholecystectomy

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