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

Impact of Ultrasound-Guided Spinal Anesthesia and Pre-Procedure Sedation on Postoperative Acute and Chronic Back Pain in Non-Obstetric Surgery.

This trial will test whether giving midazolam before ultrasound-guided spinal anesthesia lowers the chance of new or persistent back pain after elective lower abdominal or leg surgery in adults.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 180 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Benha University (other)
• Locations: 1 site (Banhā, Qalyubia Governorate)
• Trial ID: NCT07198412 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Adults aged 18–65 years with ASA physical status I–II, BMI ≤35 kg/m², scheduled for elective non-obstetric lower abdominal or lower limb surgery who can provide informed consent are ideal candidates.

Not a fit: Patients with pre-existing chronic low back pain, chronic opioid use, contraindications to spinal anesthesia, severe spinal deformity, or prior spinal surgery are excluded and are unlikely to benefit from this protocol.

Why it matters

Potential benefit: If successful, this approach could reduce both acute and chronic back pain after spinal anesthesia and improve patient comfort and satisfaction.

How similar studies have performed: Prior work suggests ultrasound guidance can reduce technical complications and pre-procedure sedation lowers anxiety and discomfort, but evidence that these measures prevent long-term post-spinal back pain is limited, so this is a relatively novel clinical question.

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

Where this trial is running

Banhā, Qalyubia Governorate

• Benha University Hospital — Banhā, Qalyubia Governorate, Egypt (RECRUITING)

Study contacts

• Study coordinator: Samar R Amin, M.D.

Conditions: Pain Management, Postoperative Acute Pain, Chronic Back Pain, Spinal anesthesia, Ultrasound-guided anesthesia, Pre-procedure sedation, Midazolam, Chronic back pain