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Recruiting NCT07198412

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

Trial Parameters

Condition Pain Management
Sponsor Benha University
Study Type INTERVENTIONAL
Phase N/A
Enrollment 180
Sex ALL
Min Age 18 Years
Max Age 65 Years
Start Date 2025-10-01
Completion 2026-04-10
Interventions
Ultrasound-guided spinal anesthesiaMidazolam plus ultrasound-guided spinal anesthesiaLandmark-guided spinal anesthesia

Brief Summary

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.

Eligibility Criteria

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

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