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Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

Primary Purpose

Biliary Disease

Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversus abdominis plane block
local infiltration anesthesia
Intravenous patient controlled analgesia
Sponsored by
Diskapi Yildirim Beyazit Education and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Biliary Disease focused on measuring Unilateral transversus abdominal plane block, Local infiltration anesthesia, Cholecystectomy, Postoperative analgesia

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

• Clinical diagnosis of biliary disease

Exclusion Criteria:

  • Uncooperative patients
  • Blood coagulation disorders
  • Laparatomy
  • Obesity: body mass index >35
  • Renal failure
  • Hepatic failure
  • Emergency surgery
  • Pregnancy

Sites / Locations

  • Diskapi Yıldırım Beyazıt EAHRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Sham Comparator

Arm Label

Transversus abdominis plane block

Local infiltration anesthesia

Intravenous patient control analgesia

Arm Description

will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia

will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia

will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia

Outcomes

Primary Outcome Measures

Postoperative analgesia
Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain)

Secondary Outcome Measures

Postoperative nausea and vomiting (PONV)
PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more
Patient satisfaction
Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)

Full Information

First Posted
May 17, 2018
Last Updated
October 22, 2018
Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03543202
Brief Title
Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy
Official Title
Comparison of Postoperative Analgesia and Patient Satisfaction of Unilateral Transversus Abdominis Plane (TAP) Block and Trocar Site Infiltration Anesthesia in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
July 2018
Overall Recruitment Status
Unknown status
Study Start Date
June 10, 2018 (Actual)
Primary Completion Date
October 30, 2018 (Anticipated)
Study Completion Date
October 30, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Diskapi Yildirim Beyazit Education and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Laparoscopic cholecystectomy is a commonly performed operation in general surgery practice. Peripheral nerve block methods commonly used for analgesia after this operation are: transversus abdominis plane block (TAP) and trocar insertion sites local anesthetic infiltration anesthesia In this study, we aimed to compare these methods in terms of postoperative analgesia, nausea-vomiting and patient satisfaction
Detailed Description
Patients will be randomly allocated by a computer generated random numbers list into three groups. After general anesthesia induction and intubation patients will receive analgesia according to group allocation. In group TAP (Group T) the transversus abdominis plane block will be commenced with ultrasound guidance while the patients is in the supine position with a subcostal approach using 20 mL 0.25% bupivacaine and 21 G block needle. In group infiltration anesthesia (Group I) the trocar insertion sites will be infiltrated with 20 mL 0.25% bupivacaine: 7 mL for the 10 mm trocar insertion sites and 3 mL for the 5 mm trocar insertion sites. The control group (Group C) will not receive any local anesthetic. All patients will receive rescue analgesia with intravenous patient controlled analgesia with tramadol (20 mg bolus dose and 20 minutes lockout time) Postoperative pain will be assessed during resting and coughing with a Numeric Pain Scale (NRS) and nausea and vomiting with a Postoperative Nausea Vomiting Score at the postoperative 1, 3, 6, 12. and 24 hours. The amount of tramadol consumed in the postoperative period will be recorded. Patient satisfaction will be assessed with the Likert scale at postoperative 24 hours.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Biliary Disease
Keywords
Unilateral transversus abdominal plane block, Local infiltration anesthesia, Cholecystectomy, Postoperative analgesia

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
prospective randomised
Masking
ParticipantOutcomes Assessor
Masking Description
patients and outcome assesors will be blinded for the analgesia method
Allocation
Randomized
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Transversus abdominis plane block
Arm Type
Experimental
Arm Description
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
Arm Title
Local infiltration anesthesia
Arm Type
Active Comparator
Arm Description
will receive 20ml bupivacaine for Local infiltration anesthesia and intravenous patient controlled analgesia
Arm Title
Intravenous patient control analgesia
Arm Type
Sham Comparator
Arm Description
will not receive any regional anethetic intervention will receive intravenous patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Transversus abdominis plane block
Intervention Description
will receive 20ml bupivacaine for Transversus abdominis plane block and intravenous patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
local infiltration anesthesia
Intervention Description
will receive 20ml bupivacaine for local infiltration anesthesia and intravenous patient controlled analgesia
Intervention Type
Drug
Intervention Name(s)
Intravenous patient controlled analgesia
Intervention Description
will not receive any regional anesthetic intervention will receive intravenous patient controlled analgesia
Primary Outcome Measure Information:
Title
Postoperative analgesia
Description
Pain will be assessed with a 11 point numeric rating scale (0-10 whereas 0:no pain; 1-3: mild pain; 4-6: moderate pain and 7-10: severe pain)
Time Frame
Postoperative day 1
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting (PONV)
Description
PONV will be assessed with a 5 point PONV intensity scale (1-4 whereas 1:absence of PONV; 2: nausea present, vomiting absent; 3 nausea present, vomiting once; 4: nausea present vomiting twice or more
Time Frame
Postoperative 1st hour, 3rd hour, 6th hour, 12th hour and 24th hour
Title
Patient satisfaction
Description
Satisfaction will be assessed with a 5 point Likert scale (0-4 whereas 0:definitely disagree; 1:slightly agree; 3: agree; 4: strongly agree)
Time Frame
Postoperative 24 th hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: • Clinical diagnosis of biliary disease Exclusion Criteria: Uncooperative patients Blood coagulation disorders Laparatomy Obesity: body mass index >35 Renal failure Hepatic failure Emergency surgery Pregnancy
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emine Arik, Dr
Phone
+905333471530
Email
emineincearik@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emine Arik, Dr
Organizational Affiliation
Ministry f Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
Diskapi Yıldırım Beyazıt EAH
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Emine Arık, DR

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
28085788
Citation
Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
Results Reference
background
PubMed Identifier
27746552
Citation
Bava EP, Ramachandran R, Rewari V, Chandralekha, Bansal VK, Trikha A. Analgesic efficacy of ultrasound guided transversus abdominis plane block versus local anesthetic infiltration in adult patients undergoing single incision laparoscopic cholecystectomy: A randomized controlled trial. Anesth Essays Res. 2016 Sep-Dec;10(3):561-567. doi: 10.4103/0259-1162.186620.
Results Reference
result
PubMed Identifier
22330261
Citation
Ortiz J, Suliburk JW, Wu K, Bailard NS, Mason C, Minard CG, Palvadi RR. Bilateral transversus abdominis plane block does not decrease postoperative pain after laparoscopic cholecystectomy when compared with local anesthetic infiltration of trocar insertion sites. Reg Anesth Pain Med. 2012 Mar-Apr;37(2):188-92. doi: 10.1097/AAP.0b013e318244851b.
Results Reference
result
PubMed Identifier
19376789
Citation
El-Dawlatly AA, Turkistani A, Kettner SC, Machata AM, Delvi MB, Thallaj A, Kapral S, Marhofer P. Ultrasound-guided transversus abdominis plane block: description of a new technique and comparison with conventional systemic analgesia during laparoscopic cholecystectomy. Br J Anaesth. 2009 Jun;102(6):763-7. doi: 10.1093/bja/aep067. Epub 2009 Apr 17. Erratum In: Br J Anaesth. 2009 Oct;103(4):622.
Results Reference
result

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Unilateral TAP Block vs Trocar Insertion Sites Infiltration Anesthesia in Laparoscopic Cholecystectomy

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