HerniorrhaphyNCT06684548
Effect of Hip/Shoulder-Width Ratio on Sensory Blockade After Intrathecal Anesthesia for Adult Subumblical Herniorraphy
An observational study of Herniorrhaphy, run by Assiut University.
Trial summary
Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Herniorrhaphy
- What is being tested?
- Hip/shoulder width ratio
- Type of treatment
- Surgery or procedure
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2025to 1 Jan 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: patients subjected to subumblical herniorraphy
Who may be able to join
- Age 20 - 50 years old
- Both sexes
- Patients who are in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
- Elective subumblical herniorraphy under intrathecal anesthesia
Who cannot join
- • Patient refusal
- Patients have a contraindication for regional anesthesia, e.g. coagulopathy.
- Failed or unsatisfactory intrathecal block.
- Patients have a central nervous system disease (mental retardation, non-cooperated speech disorder, or psychiatric disease).
- Patients who are under 150 cm or over 185 cm in height, or BMI >40.
- Patients have experienced an operation lasting more than 2 h.
- Patients with known hypersensitivity to amide local anesthetics.
- Local injection site infection or spinal deformity.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . One advantage of spinal anesthesia over general anesthesia is reduced exposure to potentially depressant drugs . However, inadequate spinal spread can result in pain and discomfort for patients and complicate surgical procedures . Consequently, anesthesiologists encounter the challenge of attaining the proper spread of spinal anesthesia for subumbilical herniorrhaphy due to individual anthropometric variations .
Approximately 25 factors have been identified that affect the spread of spinal anesthesia in the subarachnoid space for a given dose of LA . Variables that are both practically obtainable and predictive of spinal anesthesia spread can aid anesthesiologists in anticipating the extent of the block. Among the most studied factors are patient characteristics, injection techniques, patient posture, and the baricity of the LA .
Research has examined various patient variables affecting spinal anesthesia spread, including age , weight , height , gender, patient position, BMI , vertebral column length (VCL), and abdominal circumference . Body morphometrics such as the hip-shoulder width ratio (HSWR) have garnered attention for their potential impact on the distribution of anesthetic agents within the intrathecal space . Despite the well-established influence of factors like age, weight, and spinal anatomy, the specific role of HSWR in the outcomes of intrathecal anesthesia remains underexplored this study aim to To evaluate the effect of hip/shoulder-width ratio (HSWR) on sensory blockade level after intrathecal anesthesia for adult patients undergoing subumblical herniorraphy
Read the detailed description
Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . One advantage of spinal anesthesia over general anesthesia is reduced exposure to potentially depressant drugs . However, inadequate spinal spread can result in pain and discomfort for patients and complicate surgical procedures . Consequently, anesthesiologists encounter the challenge of attaining the proper spread of spinal anesthesia for subumbilical herniorrhaphy due to individual anthropometric variations .
Approximately 25 factors have been identified that affect the spread of spinal anesthesia in the subarachnoid space for a given dose of LA . Variables that are both practically obtainable and predictive of spinal anesthesia spread can aid anesthesiologists in anticipating the extent of the block. Among the most studied factors are patient characteristics, injection techniques, patient posture, and the baricity of the LA .
Research has examined various patient variables affecting spinal anesthesia spread, including age , weight , height , gender, patient position, BMI , vertebral column length (VCL), and abdominal circumference . Body morphometrics such as the hip-shoulder width ratio (HSWR) have garnered attention for their potential impact on the distribution of anesthetic agents within the intrathecal space . Despite the well-established influence of factors like age, weight, and spinal anatomy, the specific role of HSWR in the outcomes of intrathecal anesthesia remains underexplored
- Conditions
- Herniorrhaphy
- Being tested
- Hip/shoulder width ratio
- Keywords
- hip/shoulder-width ratio, sub umblical herniorrhaphy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hip/shoulder width ratioProcedure or surgery
the effect of hip/shoulder-width ratio on sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy
What is being measured
The primary outcome is the main question the study is designed to answer.
the sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy.
Measured: baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2024
- Study start1 Dec 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for HerniorrhaphyStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Amr Abdelazeem Fouad, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06684548
- Sponsor's protocol ID
- HS W Ratio Herniorraphy
- Status last verified
- Nov 2024
- First submitted
- 9 Nov 2024
- Last updated
- 12 Nov 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.
PubMed 27870737Fu F, Xiao F, Chen W, Yang M, Zhou Y, Ngan Kee WD, Chen X. A randomised double-blind dose-response study of weight-adjusted infusions of norepinephrine for preventing hypotension during combined spinal-epidural anaesthesia for Caesarean delivery. Br J Anaesth. 2020 Mar;124(3):e108-e114. doi: 10.1016/j.bja.2019.12.019. Epub 2020 Jan 17.
PubMed 31959386Chen M, Chen C, Ke Q. The effect of age on the median effective dose (ED50) of intrathecally administered plain bupivacaine for motor block. Anesth Analg. 2014 Apr;118(4):863-8. doi: 10.1213/ANE.0000000000000147.
PubMed 24651241Zhou QH, Xiao WP, Shen YY. Abdominal girth, vertebral column length, and spread of spinal anesthesia in 30 minutes after plain bupivacaine 5 mg/mL. Anesth Analg. 2014 Jul;119(1):203-206. doi: 10.1213/ANE.0000000000000199.
PubMed 24806139Adesope OA, Einhorn LM, Olufolabi AJ, Cooter M, Habib AS. The impact of gestational age and fetal weight on the risk of failure of spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2016 May;26:8-14. doi: 10.1016/j.ijoa.2016.01.007. Epub 2016 Feb 2.
PubMed 27020240Agegnehu AF, Gebregzi AH, Endalew NS. Review of evidences for management of rapid sequence spinal anesthesia for category one cesarean section, in resource limiting setting. Int J Surg Open. 2020;26:101-105. doi: 10.1016/j.ijso.2020.08.013. Epub 2020 Sep 3.
PubMed 34568612Shivashankar A, Rajappa GC, Sudarshan S, Madhu MM, Rao R. Evaluation of Effect of Hip/Shoulder-Width Ratio on the Sensory Level of Spinal Anesthesia - A Prospective Observational Study. Anesth Essays Res. 2022 Jan-Mar;16(1):80-83. doi: 10.4103/aer.aer_146_21. Epub 2022 Jun 27.
PubMed 36249129
Study at a glance
From the registry record, last updated by the sponsor on 12 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Hip/Shoulder-Width Ratio on Sensory Blockade After Intrathecal Anesthesia for Adult Subumblical Herniorraphy
- ClinicalTrials.gov ID
- NCT06684548
- Acronym / sponsor ID
- HS W Ratio Herniorraphy
- Conditions
- Herniorrhaphy
- Keywords
- hip/shoulder-width ratio, sub umblical herniorrhaphy
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Jan 2027 (estimated)
- First posted
- 12 Nov 2024 (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.
Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . One advantage of spinal anesthesia over general anesthesia is reduced exposure to potentially depressant drugs . However, inadequate spinal spread can result in pain and discomfort for patients and complicate surgical procedures . Consequently, anesthesiologists encounter the challenge of attaining the proper spread of spinal anesthesia for subumbilical herniorrhaphy due to individual anthropometric variations .
Approximately 25 factors have been identified that affect the spread of spinal anesthesia in the subarachnoid space for a given dose of LA . Variables that are both practically obtainable and predictive of spinal anesthesia spread can aid anesthesiologists in anticipating the extent of the block. Among the most studied factors are patient characteristics, injection techniques, patient posture, and the baricity of the LA .
Research has examined various patient variables affecting spinal anesthesia spread, including age , weight , height , gender, patient position, BMI , vertebral column length (VCL), and abdominal circumference . Body morphometrics such as the hip-shoulder width ratio (HSWR) have garnered attention for their potential impact on the distribution of anesthetic agents within the intrathecal space . Despite the well-established influence of factors like age, weight, and spinal anatomy, the specific role of HSWR in the outcomes of intrathecal anesthesia remains underexplored this study aim to To evaluate the effect of hip/shoulder-width ratio (HSWR) on sensory blockade level after intrathecal anesthesia for adult patients undergoing subumblical herniorraphy
Detailed description
Spinal anesthesia is a straightforward and reliable technique frequently employed in lower body surgeries, achieving adequate surgical conditions through the injection of a small amount of local anesthetic (LA) into the intrathecal space . One advantage of spinal anesthesia over general anesthesia is reduced exposure to potentially depressant drugs . However, inadequate spinal spread can result in pain and discomfort for patients and complicate surgical procedures . Consequently, anesthesiologists encounter the challenge of attaining the proper spread of spinal anesthesia for subumbilical herniorrhaphy due to individual anthropometric variations .
Approximately 25 factors have been identified that affect the spread of spinal anesthesia in the subarachnoid space for a given dose of LA . Variables that are both practically obtainable and predictive of spinal anesthesia spread can aid anesthesiologists in anticipating the extent of the block. Among the most studied factors are patient characteristics, injection techniques, patient posture, and the baricity of the LA .
Research has examined various patient variables affecting spinal anesthesia spread, including age , weight , height , gender, patient position, BMI , vertebral column length (VCL), and abdominal circumference . Body morphometrics such as the hip-shoulder width ratio (HSWR) have garnered attention for their potential impact on the distribution of anesthetic agents within the intrathecal space . Despite the well-established influence of factors like age, weight, and spinal anatomy, the specific role of HSWR in the outcomes of intrathecal anesthesia remains underexplored
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- patients subjected to subumblical herniorraphy
Key inclusion criteria (4 listed)
- Age 20 - 50 years old
- Both sexes
- Patients who are in risk-scoring groups I-II of the American Society of Anesthesiologists (ASA)
- Elective subumblical herniorraphy under intrathecal anesthesia
Key exclusion criteria (8 listed)
- • Patient refusal
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 |
|---|---|---|
| Hip/shoulder width ratiothe effect of hip/shoulder-width ratio on sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy | Procedure or surgery | – |
Primary outcome
the sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy.
Time frame: baseline
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Nov 2024.
- Results publication: PubMed 27870737Ngaka TC, Coetzee JF, Dyer RA. The Influence of Body Mass Index on Sensorimotor Block and Vasopressor Requirement During Spinal Anesthesia for Elective Cesarean Delivery. Anesth Analg. 2016 Dec;123(6):1527-1534. doi: 10.1213/ANE.0000000000001568.
- Results publication: PubMed 31959386Fu F, Xiao F, Chen W, Yang M, Zhou Y, Ngan Kee WD, Chen X. A randomised double-blind dose-response study of weight-adjusted infusions of norepinephrine for preventing hypotension during combined spinal-epidural anaesthesia for Caesarean delivery. Br J Anaesth. 2020 Mar;124(3):e108-e114. doi: 10.1016/j.bja.2019.12.019. Epub 2020 Jan 17.
- Results publication: PubMed 24651241Chen M, Chen C, Ke Q. The effect of age on the median effective dose (ED50) of intrathecally administered plain bupivacaine for motor block. Anesth Analg. 2014 Apr;118(4):863-8. doi: 10.1213/ANE.0000000000000147.
- Results publication: PubMed 24806139Zhou QH, Xiao WP, Shen YY. Abdominal girth, vertebral column length, and spread of spinal anesthesia in 30 minutes after plain bupivacaine 5 mg/mL. Anesth Analg. 2014 Jul;119(1):203-206. doi: 10.1213/ANE.0000000000000199.
- Results publication: PubMed 27020240Adesope OA, Einhorn LM, Olufolabi AJ, Cooter M, Habib AS. The impact of gestational age and fetal weight on the risk of failure of spinal anesthesia for cesarean delivery. Int J Obstet Anesth. 2016 May;26:8-14. doi: 10.1016/j.ijoa.2016.01.007. Epub 2016 Feb 2.
- Results publication: PubMed 34568612Agegnehu AF, Gebregzi AH, Endalew NS. Review of evidences for management of rapid sequence spinal anesthesia for category one cesarean section, in resource limiting setting. Int J Surg Open. 2020;26:101-105. doi: 10.1016/j.ijso.2020.08.013. Epub 2020 Sep 3.
- Results publication: PubMed 36249129Shivashankar A, Rajappa GC, Sudarshan S, Madhu MM, Rao R. Evaluation of Effect of Hip/Shoulder-Width Ratio on the Sensory Level of Spinal Anesthesia - A Prospective Observational Study. Anesth Essays Res. 2022 Jan-Mar;16(1):80-83. doi: 10.4103/aer.aer_146_21. Epub 2022 Jun 27.
- Individual participant dataSharing planned: Undecided
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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.
Questions about this trial
What is this clinical trial studying?
An observational study of Herniorrhaphy, run by Assiut 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 4 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: opening soon, as of the sponsor's last update on 12 Nov 2024. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Amr Fouad, resident doctors (+2 01015639226, amrabdelazeeem@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the sensory blockade level in patients undergoing intrathecal anesthesia for subumbilical herniorrhaphy. (time frame: baseline). 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 NCT06684548, which also lists 7 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 12 Nov 2024.