Ultrasound-guided midline versus paramedian spinal anesthesia for adults having orthopedic surgery
Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery
NA · Sohag University · NCT07047469
This will test whether ultrasound-guided midline or paramedian spinal anesthesia requires fewer needle passes in adults 18–50 having orthopedic surgery.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 110 (estimated) |
| Ages | 18 Years to 50 Years |
| Sex | All |
| Sponsor | Sohag University (other) |
| Locations | 1 site (Sohag) |
| Trial ID | NCT07047469 on ClinicalTrials.gov |
What this trial studies
This randomized interventional comparison enrolls adults aged 18–50, ASA physical status I–II, with BMI under 30 who are scheduled for orthopedic surgery at Sohag University Hospital. Participants receive ultrasound-guided spinal anesthesia using either a midline or a paramedian needle approach, and the primary outcome is the number of needle passes to successful dural puncture. The protocol records procedure-related measures such as time, patient discomfort, and any complications. Patients with prior spinal surgery, spinal deformity, coagulopathy, infection, obesity, or other contraindications to spinal anesthesia are excluded.
Who should consider this trial
Good fit: Adults 18–50 undergoing orthopedic surgery who are ASA I–II, have BMI <30, and have no spinal deformities or contraindications to spinal anesthesia.
Not a fit: Older adults, obese patients (BMI ≥30), and those with prior spinal surgery, spinal deformity, coagulopathy, active infection, or other contraindications are excluded and unlikely to benefit from this protocol.
Why it matters
Potential benefit: If successful, the preferred approach could reduce needle passes, lower patient discomfort, and decrease procedure-related complications.
How similar studies have performed: Previous studies indicate ultrasound guidance can reduce needle passes and improve first-attempt success for spinal anesthesia, though direct comparisons between midline and paramedian ultrasound-guided approaches are limited.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Patients will perform orthopedic surgery * Physical state I or II according to ASA classification * Age between (18 - 50 ) * Body mass index less than 30 Exclusion Criteria: * 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 . * Spinal stenosis . * Multiple sclerosis . * Coagulopathy. * Hypovolemia . * Systemic infection . * Aortic stenosis . * Spina bifida and back deformity .
Where this trial is running
Sohag
- Sohag University Hospital — Sohag, Egypt (RECRUITING)
Study contacts
- Study coordinator: Areej M Abd Elkader, Resident
- Email: Mareej22@yahoo.com
- Phone: 01288811379
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anesthesia, Functional