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Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain

RecruitingNAAges 18 Years - 65 YearsAllBenha University
NCT07198412 on ClinicalTrials.gov โ†—
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In plain words

What the trial is, and whether it could suit you

This study will evaluate whether giving sedation before spinal anesthesia, when performed with ultrasound guidance, reduces the risk of developing back pain after surgery. Spinal anesthesia is commonly used but may cause discomfort or persistent back pain in some patients. By comparing standard techniques, ultrasound guidance, and sedation, we aim to find safer and more comfortable approaches for patients undergoing non-obstetric surgery.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria Adults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) โ‰ค 35 kg/mยฒ Scheduled for elective non-obstetric lower abdominal or lower limb surgery under spinal anesthesia Able to provide written informed consent Exclusion Criteria Contraindications to spinal anesthesia (e.g., coagulopathy, local infection at puncture site) Pre-existing chronic low back pain Chronic opioid use Known allergy or contraindication to study medications (bupivacaine, lidocaine, midazolam) Psychiatric or neurological disorders affecting pain perception or reporting Severe spinal deformities or history of previous spinal surgery Inability to comply with follow-up assessments
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What it tests

  • Ultrasound-guided spinal anesthesia
  • Midazolam plus ultrasound-guided spinal anesthesia
  • Landmark-guided spinal anesthesia
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Where

1 site
Benha University Hospital
Banhฤ, Egypt
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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