Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal BlockNCT04805580
Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Inguinal Hernia Repair
A study testing unilateral intrathecal block in people with Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block, run by Zagazig University.
Trial summary
compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block
- What is being tested?
- unilateral intrathecal block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- May 2021to Oct 2021
- Phase
- Interventional
- 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
- physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair
Who cannot join
- uncooperative patient
- Allergy to local anesthetic drugs
- patients on chronic alcohol, opioid, tranquilizer or sedative use
- Pregnant females.
- Psychological, mental disorders, or depression.
- Patients receiving anticoagulants therapy or suspected coagulopathy.
- Patients with infection or previous surgery at sit of anesthetic procedures.
- Patients with significant cardiovascular, respiratory, renal, hepatic, or metabolic disease
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Ultrasound Guided Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Patient Undergoing Inguinal Hernia Repair
compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.
Read the detailed description
comparison between unilateral intrathecal block anesthesia (unilateral SA) and Quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. Limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events.
Previous case report studies stated that we can use Quadratus Lumborum Block as the sole anesthetic technique for open hernia repair.
- Being tested
- unilateral intrathecal block
- Medical subject headings
- Hernia, Inguinal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
unilateral intrathecal blockProcedure or surgery
Also called unilateral spinal anaesthesia
Quadratus lunborum block
| Study group | Role | What they receive |
|---|---|---|
| intrathecal block | Active comparator | patients (25) will receive unilateral intrathecal block using 1.5 ml of hyperbaric bupivacaine Receives: Procedure: unilateral intrathecal block |
| Quadratus lumborum block | Active comparator | patients (25) will receive quadratus lumborum block by an anterior approach using 30 ml of bupivacaine 0.25% Receives: Procedure: unilateral intrathecal block |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block
complications of the block in each group like inadequate blockade detected by increased dose of sedation required in this group ,hemodynamic instability related to the block detected by frequent monitoring of the blood pressure and heart rate
Measured: 2 hours
Secondary outcomes (2)
To compare the onset and duration of sensory block between both blocks
the onset of pin brick discrimination and time of first request of analgesics after block performance in each group
Measured: 12 hours
To compare the time to ambulation
the time till the patient succeed in ambulation
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2021
- Study startMay 2021 (estimated)
- Primary completionSep 2021 (estimated)
- Study completionOct 2021 (estimated)
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 Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal BlockStudies of the same condition, open and under way.
- More trials run by Zagazig 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
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 groups (25 in each group) group intrathecal block group quadratus lumborum block
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zagazig University
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Hala mohamed Rashad mohamed, Zagazig University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04805580
- Sponsor's protocol ID
- Qudratus lumborum block
- Status last verified
- Apr 2021
- First submitted
- 15 Mar 2021
- Last updated
- 6 Apr 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
PubMed 32444629La Colla L, La Colla MDL, Schroeder R, Schroeder RMD. Quadratus Lumborum Block as Sole, Homeostatic-Preserving Anesthetic for a Patient with Multiple System Atrophy Undergoing Open Inguinal Hernia Repair: A Case Report. Case Rep Anesthesiol. 2018 Jun 28;2018:7161860. doi: 10.1155/2018/7161860. eCollection 2018.
PubMed 30050698Isil CT, Cinar AS, Oba S, Isil RG. Comparison of Spinal Anaesthesia and Paravertebral Block in Unilateral Inguinal Hernia Repair. Turk J Anaesthesiol Reanim. 2014 Oct;42(5):257-63. doi: 10.5152/TJAR.2014.75508. Epub 2014 Jul 9.
PubMed 27366432
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided Qudratus Lumborum Block Versus Unilateral Intrathecal Block for Patient Undergoing Inguinal Hernia Repair
- ClinicalTrials.gov ID
- NCT04805580
- Acronym / sponsor ID
- Qudratus lumborum block
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Zagazig UniversityOther government
- Study start
- May 2021 (estimated)
- Primary completion
- Sep 2021 (estimated)
- Study completion
- Oct 2021 (estimated)
- First posted
- 18 Mar 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.
compare between Quadratus lumborum block and unilateral intrathecal block for patients undergoing inguinal hernia repair regarding the quality of anesthesia and hemodynamic stability of patients.
Detailed description
comparison between unilateral intrathecal block anesthesia (unilateral SA) and Quadratus lumborum block for inguinal hernia repair unilateral intrathecal block is widely used nowadays for unilateral inguinal hernia repair, providing intense sensory and motor blockade. Limiting the block to the operative site by using small doses of hyperbaric solutions injected slowly through a directional needle and maintaining a lateral decubitus position for a certain duration has been proposed, to produce high quality, long-duration analgesia, with minimal hemodynamic adverse events.
Previous case report studies stated that we can use Quadratus Lumborum Block as the sole anesthetic technique for open hernia repair.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- 2 groups (25 in each group) group intrathecal block group quadratus lumborum block
| Arm | Type | Receives |
|---|---|---|
| intrathecal block | Active comparator | Procedure: unilateral intrathecal blockpatients (25) will receive unilateral intrathecal block using 1.5 ml of hyperbaric bupivacaine |
| Quadratus lumborum block | Active comparator | Procedure: unilateral intrathecal blockpatients (25) will receive quadratus lumborum block by an anterior approach using 30 ml of bupivacaine 0.25% |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- physical status ASA: I-II BMI >18kg/m2<30kg/m2 written informed consent from the patient scheduled for open unilateral inguinal hernia repair
Key exclusion criteria (8 listed)
- uncooperative patient
- Allergy to local anesthetic drugs
- patients on chronic alcohol, opioid, tranquilizer or sedative use
- Pregnant females.
- Psychological, mental disorders, or depression.
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 |
|---|---|---|
| unilateral intrathecal blockAlso: unilateral spinal anaesthesiaQuadratus lunborum block | Procedure or surgery | Quadratus lumborum block, intrathecal block |
Primary outcome
To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block
Time frame: 2 hours
complications of the block in each group like inadequate blockade detected by increased dose of sedation required in this group ,hemodynamic instability related to the block detected by frequent monitoring of the blood pressure and heart rate
2 secondary outcomes
To compare the onset and duration of sensory block between both blocks
Time frame: 12 hours
To compare the time to ambulation
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2021.
- Background: PubMed 32444629Favaro ML, Gabor S, Souza DBF, Araujo AA, Milani ALC, Ribeiro Junior MAF. Quadratus Lumborum Block As A Single Anesthetic Method For Laparoscopic Totally Extraperitoneal (Tep) Inguinal Hernia Repair: A Randomized Clinical Trial. Sci Rep. 2020 May 22;10(1):8526. doi: 10.1038/s41598-020-65604-x.
- Background: PubMed 30050698La Colla L, La Colla MDL, Schroeder R, Schroeder RMD. Quadratus Lumborum Block as Sole, Homeostatic-Preserving Anesthetic for a Patient with Multiple System Atrophy Undergoing Open Inguinal Hernia Repair: A Case Report. Case Rep Anesthesiol. 2018 Jun 28;2018:7161860. doi: 10.1155/2018/7161860. eCollection 2018.
- Background: PubMed 27366432Isil CT, Cinar AS, Oba S, Isil RG. Comparison of Spinal Anaesthesia and Paravertebral Block in Unilateral Inguinal Hernia Repair. Turk J Anaesthesiol Reanim. 2014 Oct;42(5):257-63. doi: 10.5152/TJAR.2014.75508. Epub 2014 Jul 9.
- Individual participant dataSharing planned: Yes
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.
Questions about this trial
What is this clinical trial studying?
A study testing unilateral intrathecal block in people with Inguinal Hernia,Quadratus Lumborum Block , Unilateral Intrathecal Block, run by Zagazig University.
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 8 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: status not confirmed, as of the sponsor's last update on 6 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.
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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hala Rashad (+201148737769, rashad_hala@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess safety of quadratus lumborum block vs unilateral intrathecal block for inguinal hernia repair: complications of the block (time frame: 2 hours). 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 NCT04805580, 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 6 Apr 2021.