Sedation before ultrasound-guided spinal anesthesia to reduce back pain after surgery.

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized controlled trial will enroll 180 adults scheduled for elective non-obstetric lower abdominal or lower limb surgery and randomize them to ultrasound-guided spinal anesthesia with midazolam, ultrasound-guided spinal anesthesia without sedation, or landmark-guided spinal anesthesia (control). All participants will receive standardized spinal anesthesia techniques, with midazolam given before the procedure in the sedation arm. Pain outcomes will be measured early after surgery and at 1, 3, and 6 months using validated pain scales, and secondary outcomes include number of needle attempts, procedure time, patient satisfaction, and complications. The trial is single-center at Benha University Hospital and excludes patients with pre-existing chronic low back pain, chronic opioid use, or other contraindications to spinal anesthesia.

Why it matters

Who can join: the full rules

Inclusion Criteria

Adults aged 18-65 years ASA physical status I-II Body Mass Index (BMI) ≤ 35 kg/m² 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

Where it's running

• Benha University Hospital
  Banhā, Qalyubia Governorate, Egypt Recruiting

Study contacts

• Study coordinator: Samar R Amin, M.D.
• Email: samar.rafik@gmail.com
• Phone: +201287793991

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.