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Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

Primary Purpose

Cholecystectomy, Laparoscopic, Pain, Postoperative

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Levobupivacaine 0.25 %
Levobupivacaine 0.5%
Sponsored by
Duzce University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cholecystectomy, Laparoscopic focused on measuring Transversus abdominis plane block, levobupivacaine

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • ASA I-II risk group,
  • between the ages of 20-60,
  • undergo elective laporoscopic cholecystectomy operation under general anesthesia

Exclusion Criteria:

  • allergy to anesthetic medication,
  • coronary artery patients,
  • obese patients,
  • emergencies,
  • pregnants,
  • abdomen operation history
  • heart block

Sites / Locations

  • Duzce University Medical Faculty

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

No Intervention

Experimental

Arm Label

local infiltration

Control

TAP

Arm Description

Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation

Only routine general anesthesia will be applied

Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.

Outcomes

Primary Outcome Measures

postoperative pain scores
VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,

Secondary Outcome Measures

postoperative total analgesic consumption

Full Information

First Posted
July 7, 2014
Last Updated
July 20, 2020
Sponsor
Duzce University
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1. Study Identification

Unique Protocol Identification Number
NCT02185716
Brief Title
Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery
Official Title
Comparison Of Ultrasound Guided Transversus Abdominis Plane Block (TAP) and Local Infiltration Analgesia During Laparoscopic Cholecystectomy Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
July 2020
Overall Recruitment Status
Completed
Study Start Date
January 2014 (Actual)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
Postoperative pain is a significant cause of increased morbidity in the perioperative period, leading to patient discomfort and greater hospital length of stay. Laparoscopic cholecystectomy associated with significant postoperative pain, a substantial component of which is derived from abdominal wall incisions. Ultrasound-guided TAP block increasingly has been used for providing pain relief following abdominal surgery. We designed this study with the hypothesis that, administering TAP block with levobupivacaine in laparoscopic cholecystectomy provides superior analgesic effects than port-side infiltration.
Detailed Description
In this randomized and double-blind study, 75 patients, American Society of Anesthesiology (ASA) I-II risk group, between the ages of 20-60, who will undergo elective laporoscopic cholecystectomy operation under general anesthesia will be accepted. The patients will be divided into three groups and they will be given postoperative pain treatment with patient-controlled analgesia device. In hours of postoperative 1, 2, 4, 8, 12, 16 and 24, Visual analog scale (VAS) I (superficial pain), VAS II (deep pain), postoperative total analgesic proportion, nausea and vomiting, evaluation postoperative sedation score will be recorded (as conscious:0, asleep:1, deep sleep:2 ) in hours of postoperative 1, 2, 4, 8, 12, 16 and 24.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cholecystectomy, Laparoscopic, Pain, Postoperative
Keywords
Transversus abdominis plane block, levobupivacaine

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
Care ProviderInvestigator
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
local infiltration
Arm Type
Active Comparator
Arm Description
Group L (n=25) will be given total 30 ml 0.25 % levobupivacaine infiltration around trocar-site with injector in sterilized conditions without administering TAP block at the end of the operation
Arm Title
Control
Arm Type
No Intervention
Arm Description
Only routine general anesthesia will be applied
Arm Title
TAP
Arm Type
Experimental
Arm Description
Group T (n=25) will be given bilateral total 30 ml 0.25 % levobupivacaine administering TAP block under the guidance of ultrasound at the preoperative period.
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 0.25 %
Other Intervention Name(s)
chirocaine
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine 0.5%
Other Intervention Name(s)
chirocaine
Primary Outcome Measure Information:
Title
postoperative pain scores
Description
VAS I (superficial pain), VAS II (deep pain) recorded in hours of postoperative 1, 2, 4, 8, 12, 16 and 24 h,
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
postoperative total analgesic consumption
Time Frame
Postoperatively 24 h
Other Pre-specified Outcome Measures:
Title
side effects
Description
In hours of postoperative 1, 2, 4, 8, 12, 16 and 24 nausea, and vomiting will be recorded.Nausea (0=non-existent, 1=mild, 2 = severe) and vomiting (0=non-existent, 1=mild, 2 = severe) of the patients will be scored postoperatively on a 3-point scale.
Time Frame
postoperatively 24 h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: ASA I-II risk group, between the ages of 20-60, undergo elective laporoscopic cholecystectomy operation under general anesthesia Exclusion Criteria: allergy to anesthetic medication, coronary artery patients, obese patients, emergencies, pregnants, abdomen operation history heart block
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gülbin Sezen, MD,PhD
Organizational Affiliation
Duzce University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duzce University Medical Faculty
City
Duzce
ZIP/Postal Code
81160
Country
Turkey

12. IPD Sharing Statement

Citations:
PubMed Identifier
24348067
Citation
Wassef M, Lee DY, Levine JL, Ross RE, Guend H, Vandepitte C, Hadzic A, Teixeira J. Feasibility and analgesic efficacy of the transversus abdominis plane block after single-port laparoscopy in patients having bariatric surgery. J Pain Res. 2013 Nov 27;6:837-41. doi: 10.2147/JPR.S50561. eCollection 2013.
Results Reference
result
PubMed Identifier
23770342
Citation
Keir A, Rhodes L, Kayal A, Khan OA. Does a transversus abdominis plane (TAP) local anaesthetic block improve pain control in patients undergoing laparoscopic cholecystectomy? A best evidence topic. Int J Surg. 2013;11(9):792-4. doi: 10.1016/j.ijsu.2013.05.039. Epub 2013 Jun 11.
Results Reference
result

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Transversus Abdominis Plane Block (TAP) for Laparoscopic Cholecystectomy Surgery

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