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Recruiting NCT07047469

Ultrasound-assisted Spinal Anesthesia in Midline Versus Paramedian Approach in Adult Orthopedic Surgery

No phase Interventional Anesthesia; Functional

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Group (1): spinal anesthesia with median approach, Group (2): spinal anesthesia with paramedian approach.
Who it may be relevant to
Registry conditions: Anesthesia; Functional. Basic parameters: 18 years — 50 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Procedure Group (1): spinal anesthesia with median approach
    patients undergoing orthopedic surgery will receive spinal anesthesia with median approach under ultrasound guided techniques
  • Procedure Group (2): spinal anesthesia with paramedian approach
    patients undergoing orthopedic surgery will receive spinal anesthesia with paramedian approach under ultrasound guided techniques

Primary outcome measures

  • 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.]

Eligibility 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 .

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

Egypt · 1 center
  • Sohag University Hospital — Sohag

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. PMID 35907825
  • Singh 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. PMID 29628579
  • Wilson 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. PMID 31005435

Identifiers

NCT: NCT07047469 · Soh-Med--25-6-16MS

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗