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Postoperative Effects of TAP Block Versus QLB Type 2 Block

Primary Purpose

Inguinal Hernia, Postoperative Pain

Status
Completed
Phase
Phase 4
Locations
Turkey
Study Type
Interventional
Intervention
Acetaminophen
0.25% Bupivacaine
0.5% Bupivacaine+Glucose
Tramadol HCl
Inguinal Hernia Repair
0.25% Bupivacaine
Sponsored by
Bozyaka Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Inguinal Hernia

Eligibility Criteria

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

Inclusion Criteria:

  • Patients who are over 18 years of age
  • Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques
  • Patients who are in ASA's physical status score group 1 or 2

Exclusion Criteria:

  • Patients who are younger than 18 years of age
  • Patients who have severe stenotic heart diseases
  • Patients who have bleeding diathesis
  • Patients who have true allergies to local anesthetics
  • Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques

Sites / Locations

  • Izmir Bozyaka Training and Research Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Active Comparator

Arm Label

TAP

QLB2

CONT

Arm Description

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.

Outcomes

Primary Outcome Measures

Pain Intensity
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever
Pain Intensity
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever)
Pain Intensity
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever
Pain Intensity
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever

Secondary Outcome Measures

Full Information

First Posted
April 20, 2017
Last Updated
November 11, 2017
Sponsor
Bozyaka Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03126084
Brief Title
Postoperative Effects of TAP Block Versus QLB Type 2 Block
Official Title
Comparison of Postoperative Analgesic Effects of Transversus Abdominis Plane Block and Quadratus Lumborum Block Type 2
Study Type
Interventional

2. Study Status

Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
May 2, 2017 (Actual)
Primary Completion Date
November 11, 2017 (Actual)
Study Completion Date
November 11, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Bozyaka Training 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
This study compares analgesic effectiveness of transversus abdominis plane block and quadratus lumborum block type 2 in open hernia repair surgery. All of the patients will receive routine intravenous analgesic regimen. In addition to that one-third of the patients will receive transversus abdominis plane block, one-third will receive quadratus lumborum block type 2. One-third of the patients will not receive any blocks and will constitute the control group

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inguinal Hernia, Postoperative Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
TAP
Arm Type
Active Comparator
Arm Description
Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive transversus abdominis plane block with 20 ml of 0.25% bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
Arm Title
QLB2
Arm Type
Active Comparator
Arm Description
Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive quadratus lumborum type 2 block with 20 ml of %0.25 bupivacaine preoperatively, in addition to intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
Arm Title
CONT
Arm Type
Active Comparator
Arm Description
Patients will undergo inguinal hernia repair under subarachnoid block with 0.5% bupivacaine+glucose. Patients will receive intravenous acetaminophen 1000mg twice a day for postoperative analgesia. Tramadol HCl 50mg intramuscular will be provided for salvage analgesia postoperatively.
Intervention Type
Drug
Intervention Name(s)
Acetaminophen
Other Intervention Name(s)
Postoperative routine analgesia
Intervention Description
1000 mg of intravenous acetaminophen will be administered twice a day
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
Transversus abdominis plane block
Intervention Description
20 ml of 0.25% bupivacaine will be administered to the fascia of the transversus abdominis muscle under ultrasound guidance.
Intervention Type
Drug
Intervention Name(s)
0.5% Bupivacaine+Glucose
Other Intervention Name(s)
Subarachnoid Block
Intervention Description
15mg of 0.5% bupivacaine will be administered to subarachnoid space through 25G spinal needle
Intervention Type
Drug
Intervention Name(s)
Tramadol HCl
Other Intervention Name(s)
Postoperative Salvage Analgesia
Intervention Description
50mg of intramuscular tramadol will be administered when pain score is greater than 3 according to NRS
Intervention Type
Procedure
Intervention Name(s)
Inguinal Hernia Repair
Intervention Description
Patients will undergo open inguinal hernia repair with one of the tension free mesh techniques
Intervention Type
Drug
Intervention Name(s)
0.25% Bupivacaine
Other Intervention Name(s)
Quadratus lumborum block type 2
Intervention Description
10 ml 0.25% bupivacaine will be administered quadratus lumborum muscle and erector spinae muscle
Primary Outcome Measure Information:
Title
Pain Intensity
Description
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever
Time Frame
24 hours after surgery
Title
Pain Intensity
Description
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever)
Time Frame
2 hours after surgery
Title
Pain Intensity
Description
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever
Time Frame
6 hours after surgery
Title
Pain Intensity
Description
Postoperative pain intensity according Numeric Rating Scale between 0-10 (0=no pain, 10=worst pain ever
Time Frame
48 hours after surgery

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients who are over 18 years of age Patients who are scheduled for elective unilateral open hernia repair with tension free mesh techniques Patients who are in ASA's physical status score group 1 or 2 Exclusion Criteria: Patients who are younger than 18 years of age Patients who have severe stenotic heart diseases Patients who have bleeding diathesis Patients who have true allergies to local anesthetics Patients who have neurologic deficits corresponding to effect site of the anesthetic techniques
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zeki T TEKGUL, MD
Organizational Affiliation
Izmir Bozyaka Training and Research Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Izmir Bozyaka Training and Research Hospital
City
Izmir
ZIP/Postal Code
35170
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
17179269
Citation
McDonnell JG, O'Donnell B, Curley G, Heffernan A, Power C, Laffey JG. The analgesic efficacy of transversus abdominis plane block after abdominal surgery: a prospective randomized controlled trial. Anesth Analg. 2007 Jan;104(1):193-7. doi: 10.1213/01.ane.0000250223.49963.0f. Erratum In: Anesth Analg. 2007 May;104(5):1108.
Results Reference
background
PubMed Identifier
22705951
Citation
Baerentzen F, Maschmann C, Jensen K, Belhage B, Hensler M, Borglum J. Ultrasound-guided nerve block for inguinal hernia repair: a randomized, controlled, double-blind study. Reg Anesth Pain Med. 2012 Sep-Oct;37(5):502-7. doi: 10.1097/AAP.0b013e31825a3c8a.
Results Reference
background
PubMed Identifier
20377549
Citation
Finnerty O, Carney J, McDonnell JG. Trunk blocks for abdominal surgery. Anaesthesia. 2010 Apr;65 Suppl 1:76-83. doi: 10.1111/j.1365-2044.2009.06203.x.
Results Reference
background
PubMed Identifier
34537121
Citation
Okur O, Karaduman D, Tekgul ZT, Koroglu N, Yildirim M. Posterior quadratus lumborum versus transversus abdominis plane block for inguinal hernia repair: a prospective randomized controlled study. Braz J Anesthesiol. 2021 Sep-Oct;71(5):505-510. doi: 10.1016/j.bjane.2020.11.004. Epub 2021 Feb 10.
Results Reference
derived

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Postoperative Effects of TAP Block Versus QLB Type 2 Block

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