- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05122351
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
February 11, 2023 updated by: Ahmed Mamdouh Ahmed, Sohag University
Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Study Overview
Status
Completed
Detailed Description
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Early Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Sohag, Egypt
- Sohag university Hospital
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 60 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Group of Bupivacaine infiltration at the Quadratus Lumborum muscle
Patients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery
|
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
|
EXPERIMENTAL: Group of paracetamol injection
Patients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery
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Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Analgesia in Patients with Open Inguinal Hernia Surgeries
Time Frame: 6 months
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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
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6 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
October 1, 2021
Primary Completion (ACTUAL)
December 1, 2022
Study Completion (ACTUAL)
December 1, 2022
Study Registration Dates
First Submitted
October 19, 2021
First Submitted That Met QC Criteria
November 13, 2021
First Posted (ACTUAL)
November 16, 2021
Study Record Updates
Last Update Posted (ESTIMATE)
February 14, 2023
Last Update Submitted That Met QC Criteria
February 11, 2023
Last Verified
February 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathological Conditions, Anatomical
- Hernia, Abdominal
- Hernia
- Hernia, Inguinal
- Physiological Effects of Drugs
- Central Nervous System Depressants
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Anesthetics
- Analgesics, Non-Narcotic
- Antipyretics
- Anesthetics, Local
- Acetaminophen
- Bupivacaine
Other Study ID Numbers
- Soh-Med-21-10-06
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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