Anesthesia; FunctionalNCT07047469
Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery
A study testing Group (1): spinal anesthesia with median approach and Group (2): spinal anesthesia with paramedian approach in people with Anesthesia; Functional, run by Sohag University at 1 site in Egypt.
Trial summary
This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture. Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Anesthesia; Functional
- What is being tested?
- Group (1): spinal anesthesia with median approach and Group (2): spinal anesthesia with paramedian approach
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteEgypt
- Study dates
- 13 Jun 2025to 20 Dec 2025
- Phase
- Interventional
- 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 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients will perform orthopedic surgery
- Physical state I or II according to ASA classification
- Age between (18 - 50 )
- Body mass index less than 30
Who cannot join
- Patient refusal .
- Local infection at the puncture site .
- Allergy to any of the drugs to be administrated .
- Old age patients
- Obese patients
- Previous spinal surgery .
Show all 13Show fewer
- Spinal stenosis .
- Multiple sclerosis .
- Coagulopathy.
- Hypovolemia .
- Systemic infection .
- Aortic stenosis .
- Spina bifida and back deformity .
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Ahmed E Abd Elrahman, Professor contact
Egypt1 site, 1 recruiting
- Recruiting
Sohag University Hospital
Sohag
Magdy M Amin, Professor, 01090801900
About this study
This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture.
- Conditions
- Anesthesia; Functional
- Being tested
- Group (1): spinal anesthesia with median approach, Group (2): spinal anesthesia with paramedian approach
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group (1): spinal anesthesia with median approachProcedure or surgery
patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques
Group (2): spinal anesthesia with paramedian approachProcedure or surgery
patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques
| Study group | Role | What they receive |
|---|---|---|
| Group (1): spinal anesthesia with median approach | Active comparator | patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques Receives: Procedure: Group (1): spinal anesthesia with median approach |
| Group (2): spinal anesthesia with paramedian approach | Active comparator | patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques Receives: Procedure: Group (2): spinal anesthesia with paramedian approach |
What is being measured
The primary outcome is the main question the study is designed to answer.
The severity of back pain in patients that will receive spinal anesthesia by median versus paramedian approach
pain measurement by numerical rating scale (NRS)
Measured: 24 hours, 72 hours, and 1 week after spinal anesthesia.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2025
- Study start13 Jun 2025
- Primary completion20 Dec 2025 (estimated)
- Study completion20 Dec 2025 (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 Anesthesia; FunctionalStudies 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
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 110 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sohag University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Areej Mohamed Abdelkader, Sohag University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07047469
- Sponsor's protocol ID
- Soh-Med--25-6-16MS
- Status last verified
- Jun 2025
- First submitted
- 24 Jun 2025
- Last updated
- 2 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Zeng W, Shi Y, Zheng Q, Du S. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022 Jul 30;22(1):242. doi: 10.1186/s12871-022-01751-0.
PubMed 35907825Singh B, Sohal AS, Singh I, Goyal S, Kaur P, Attri JP. Incidence of Postspinal Headache and Low Backache Following the Median and Paramedian Approaches in Spinal Anesthesia. Anesth Essays Res. 2018 Jan-Mar;12(1):186-189. doi: 10.4103/aer.AER_139_17.
PubMed 29628579Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.
PubMed 31005435
Study at a glance
From the registry record, last updated by the sponsor on 2 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery
- ClinicalTrials.gov ID
- NCT07047469
- Acronym / sponsor ID
- Soh-Med--25-6-16MS
- Conditions
- Anesthesia; Functional
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 110 participants (estimated)
- Lead sponsor
- Sohag UniversityUniversity, hospital or other
- Study start
- 13 Jun 2025 (actual)
- Primary completion
- 20 Dec 2025 (estimated)
- Study completion
- 20 Dec 2025 (estimated)
- First posted
- 2 Jul 2025 (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.
This study aims to compare between the two methods (midline and paramedian approach of spinal anesthesia guided by ultrasound) by the number of needle passes required to successful dural puncture.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group (1): spinal anesthesia with median approach | Active comparator | Procedure: Group (1): spinal anesthesia with median approachpatients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques |
| Group (2): spinal anesthesia with paramedian approach | Active comparator | Procedure: Group (2): spinal anesthesia with paramedian approachpatients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Patients will perform orthopedic surgery
- Physical state I or II according to ASA classification
- Age between (18 - 50 )
- Body mass index less than 30
Key exclusion criteria (13 listed)
- Patient refusal .
- Local infection at the puncture site .
- Allergy to any of the drugs to be administrated .
- Old age patients
- Obese patients
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 |
|---|---|---|
| Group (1): spinal anesthesia with median approachpatients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques | Procedure or surgery | Group (1): spinal anesthesia with median approach |
| Group (2): spinal anesthesia with paramedian approachpatients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques | Procedure or surgery | Group (2): spinal anesthesia with paramedian approach |
Primary outcome
The severity of back pain in patients that will receive spinal anesthesia by median versus paramedian approach
Time frame: 24 hours, 72 hours, and 1 week after spinal anesthesia.
pain measurement by numerical rating scale (NRS)
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 2 Jul 2025.
- Background: PubMed 35907825Zeng W, Shi Y, Zheng Q, Du S. Ultrasound-assisted modified paramedian technique for spinal anesthesia in elderly. BMC Anesthesiol. 2022 Jul 30;22(1):242. doi: 10.1186/s12871-022-01751-0.
- Background: PubMed 29628579Singh B, Sohal AS, Singh I, Goyal S, Kaur P, Attri JP. Incidence of Postspinal Headache and Low Backache Following the Median and Paramedian Approaches in Spinal Anesthesia. Anesth Essays Res. 2018 Jan-Mar;12(1):186-189. doi: 10.4103/aer.AER_139_17.
- Background: PubMed 31005435Wilson JM, Farley KX, Erens GA, Guild GN 3rd. General vs Spinal Anesthesia for Revision Total Knee Arthroplasty: Do Complication Rates Differ? J Arthroplasty. 2019 Jul;34(7):1417-1422. doi: 10.1016/j.arth.2019.03.048. Epub 2019 Mar 28.
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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.
Ahmed E Abd Elrahman, Professor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group (1): spinal anesthesia with median approach and Group (2): spinal anesthesia with paramedian approach in people with Anesthesia; Functional, 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 4 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 2 Jul 2025. 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.
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 Areej M Abd Elkader, Resident (01288811379, Mareej22@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The severity of back pain in patients that will receive spinal anesthesia by median versus paramedian approach (time frame: 24 hours, 72 hours, and 1 week after spinal anesthesia.). 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 NCT07047469, 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 2 Jul 2025.