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Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

Primary Purpose

Analgesia in Patients With Open Inguinal Hernia Surgeries

Status
Completed
Phase
Early Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries
Sponsored by
Sohag University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Analgesia in Patients With Open Inguinal Hernia Surgeries

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 50 patients with ASA grade I to II, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study.

Exclusion Criteria:

  • Patient refusal
  • Patient with significant neurological , psychiatric or neuromuscular disease.
  • Pregnancy or lactating women.
  • Suspected Coagulopathy .
  • Morbid obesity.
  • Known allergy to some medications .
  • Septicaemia and local infection at the block site .
  • Alcoholism .
  • Drug abuse

Sites / Locations

  • Sohag University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Group of Bupivacaine infiltration at the Quadratus Lumborum muscle

Group of paracetamol injection

Arm Description

Patients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery

Patients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery

Outcomes

Primary Outcome Measures

Analgesia in Patients with Open Inguinal Hernia Surgeries
Comparative Study Between The Efficacy Of Quadratus Lumborum Block by Bupivacaine infiltration VS Conventional Analgesia by paracetamol injection In Patients Undergoing Open Inguinal Hernia Surgical Repair

Secondary Outcome Measures

Full Information

First Posted
October 19, 2021
Last Updated
February 11, 2023
Sponsor
Sohag University
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1. Study Identification

Unique Protocol Identification Number
NCT05122351
Brief Title
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Official Title
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
October 1, 2021 (Actual)
Primary Completion Date
December 1, 2022 (Actual)
Study Completion Date
December 1, 2022 (Actual)

3. Sponsor/Collaborators

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

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
Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Detailed Description
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Analgesia in Patients With Open Inguinal Hernia Surgeries

7. Study Design

Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group of Bupivacaine infiltration at the Quadratus Lumborum muscle
Arm Type
Experimental
Arm Description
Patients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery
Arm Title
Group of paracetamol injection
Arm Type
Experimental
Arm Description
Patients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery
Intervention Type
Drug
Intervention Name(s)
Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries
Intervention Description
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Primary Outcome Measure Information:
Title
Analgesia in Patients with Open Inguinal Hernia Surgeries
Description
Comparative Study Between The Efficacy Of Quadratus Lumborum Block by Bupivacaine infiltration VS Conventional Analgesia by paracetamol injection In Patients Undergoing Open Inguinal Hernia Surgical Repair
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 50 patients with ASA grade I to II, posted for open inguinal hernia surgery, elective , 18 to 60 years old , will be included in double blinded randomized study. Exclusion Criteria: Patient refusal Patient with significant neurological , psychiatric or neuromuscular disease. Pregnancy or lactating women. Suspected Coagulopathy . Morbid obesity. Known allergy to some medications . Septicaemia and local infection at the block site . Alcoholism . Drug abuse
Facility Information:
Facility Name
Sohag University Hospital
City
Sohag
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
21928388
Citation
Joshi GP, Rawal N, Kehlet H; PROSPECT collaboration; Bonnet F, Camu F, Fischer HB, Neugebauer EA, Schug SA, Simanski CJ. Evidence-based management of postoperative pain in adults undergoing open inguinal hernia surgery. Br J Surg. 2012 Feb;99(2):168-85. doi: 10.1002/bjs.7660. Epub 2011 Sep 16.
Results Reference
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PubMed Identifier
11711938
Citation
Rab M, Ebmer And J, Dellon AL. Anatomic variability of the ilioinguinal and genitofemoral nerve: implications for the treatment of groin pain. Plast Reconstr Surg. 2001 Nov;108(6):1618-23. doi: 10.1097/00006534-200111000-00029.
Results Reference
background
PubMed Identifier
25025697
Citation
Bulka CM, Shotwell MS, Gupta RK, Sandberg WS, Ehrenfeld JM. Regional anesthesia, time to hospital discharge, and in-hospital mortality: a propensity score matched analysis. Reg Anesth Pain Med. 2014 Sep-Oct;39(5):381-6. doi: 10.1097/AAP.0000000000000121. Erratum In: Reg Anesth Pain Med. 2015 May-Jun;40(3):297.
Results Reference
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Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair

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