Analgesia in Patients With Open Inguinal Hernia SurgeriesEarly Phase 1NCT05122351
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
A Early Phase 1 study testing Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries in people with Analgesia in Patients With Open Inguinal Hernia Surgeries, run by Sohag University at 1 site in Egypt.
Trial summary
Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia in Patients With Open Inguinal Hernia Surgeries
- What is being tested?
- Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2021to 1 Dec 2022
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- Patient refusal
- Patient with significant neurological , psychiatric or neuromuscular disease.
- Pregnancy or lactating women.
- Suspected Coagulopathy .
- Morbid obesity.
- Known allergy to some medications .
Show all 9Show fewer
- Septicaemia and local infection at the block site .
- Alcoholism .
- Drug abuse
Trial locations and contacts
1 site in 1 country.
About this study
Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
Read the detailed description
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
- Being tested
- Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeriesDrug
Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
| Study group | Role | What they receive |
|---|---|---|
| Group of Bupivacaine infiltration at the Quadratus Lumborum muscle | Experimental | Patients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery Receives: Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries |
| Group of paracetamol injection | Experimental | Patients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery Receives: Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Nov 2021
- Study start1 Oct 2021
- Primary completion1 Dec 2022
- Study completion1 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Analgesia in Patients With Open Inguinal Hernia SurgeriesStudies of the same condition, open and under way.
- More trials run by Sohag UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Mamdouh Ahmed, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05122351
- Sponsor's protocol ID
- Soh-Med-21-10-06
- Status last verified
- Feb 2023
- First submitted
- 19 Oct 2021
- Last updated
- 14 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 21928388Rab 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.
PubMed 11711938Bulka 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.
PubMed 25025697
Study at a glance
From the registry record, last updated by the sponsor on 14 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair
- ClinicalTrials.gov ID
- NCT05122351
- Acronym / sponsor ID
- Soh-Med-21-10-06
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 1 Oct 2021 (actual)
- Primary completion
- 1 Dec 2022 (actual)
- Study completion
- 1 Dec 2022 (actual)
- First posted
- 16 Nov 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group of Bupivacaine infiltration at the Quadratus Lumborum muscle | Experimental | Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeriesPatients will receive Quadratus Lumborum Block by infiltration of Bupivacaine as post operative analgesia in Open Inguinal Hernia surgery |
| Group of paracetamol injection | Experimental | Drug: Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeriesPatients will receive post operative 1 gm paracetamol injection as analgesia in Open Inguinal Hernia surgery |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (9 listed)
- Patient refusal
- Patient with significant neurological , psychiatric or neuromuscular disease.
- Pregnancy or lactating women.
- Suspected Coagulopathy .
- Morbid obesity.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeriesComparative Study Between The Efficacy Of Quadratus Lumborum Block VS Conventional Analgesia In Patients Undergoing Open Inguinal Hernia Surgical Repair | Drug | Group of Bupivacaine infiltration at the Quadratus Lumborum muscle, Group of paracetamol injection |
Primary outcome
Analgesia in Patients with Open Inguinal Hernia Surgeries
Time frame: 6 months
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Feb 2023.
- Background: PubMed 21928388Joshi 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.
- Background: PubMed 11711938Rab 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.
- Background: PubMed 25025697Bulka 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.
- Individual participant dataSharing planned: Undecided
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Bupivacaine infiltration at the Quadratus Lumborum muscle Versus Paracetamol injection as analgesia in post operative Open Inguinal Hernia surgeries in people with Analgesia in Patients With Open Inguinal Hernia Surgeries, run by Sohag University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Analgesia in Patients with Open Inguinal Hernia Surgeries (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05122351, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2023.