Status:
RECRUITING
Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain
Lead Sponsor:
Benha University
Conditions:
Pain Management
Postoperative Acute Pain
Eligibility:
All Genders
18-65 years
Phase:
NA
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 commonl...
Detailed Description
Spinal anesthesia is widely used for abdominal and lower limb surgeries, yet a significant number of patients experience new back pain afterward, sometimes lasting for months. Contributing factors inc...
Eligibility Criteria
Inclusion
- 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
Exclusion
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 10 2026
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT07198412
Start Date
October 1 2025
End Date
May 10 2026
Last Update
November 17 2025
Active Locations (1)
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1
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt, 13511