NCT07198412

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

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 180 (estimated)
• Sponsor: Benha University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

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 include needle size, multiple puncture attempts, and patient characteristics. Ultrasound guidance can improve accuracy and reduce complications, while pre-procedure sedation may lower anxiety and discomfort during the procedure. This randomized controlled trial will include 180 adult patients scheduled for non-obstetric surgery. Participants will be divided into three groups: Ultrasound-guided spinal anesthesia without sedation Ultrasound-guided spinal anesthesia with sedation (midazolam) Landmark-guided spinal anesthesia (control) Sedation will be administered with midazolam before the spinal procedure in the sedation group. All patients will receive standardized anesthesia techniques. Pain will be assessed in the early postoperative period and during long-term follow-up (1, 3, and 6 months) using validated pain scales and questionnaires. Secondary outcomes include pain severity, number of needle attempts, procedure time, patient satisfaction, and complications such as headache or nausea. This study will clarify whether combining ultrasound guidance with pre-procedure sedation can reduce both acute and chronic back pain after spinal anesthesia, aiming to improve patient safety, comfort, and satisfaction.

Conditions

• Pain Management
• Postoperative Acute Pain
• Chronic Back Pain

Interventions

Type	Name	Description
PROCEDURE	Ultrasound-guided spinal anesthesia	Spinal anesthesia performed under real-time ultrasound guidance using a curvilinear ultrasound probe and 25-27G pencil-point spinal needle. Intrathecal injection of bupivacaine 0.5% hyperbaric (12-15 mg) following local infiltration with lidocaine 1% (2-3 mL).
DRUG	Midazolam plus ultrasound-guided spinal anesthesia	Patients will receive midazolam (0.02-0.05 mg/kg IV; max 5 mg) 5-10 minutes prior to spinal anesthesia. Ultrasound guidance used for spinal needle placement. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration. Oxygen supplementation at 2 L/min and standard monitoring.
PROCEDURE	Landmark-guided spinal anesthesia	Spinal anesthesia performed using the traditional landmark palpation technique without ultrasound guidance or sedation. Intrathecal bupivacaine 0.5% hyperbaric (12-15 mg) after lidocaine 1% (2-3 mL) infiltration, using a 25-27G pencil-point spinal needle.

Timeline

• Start date: 2025-10-01
• Primary completion: 2026-04-10
• Completion: 2026-05-10
• First posted: 2025-09-30
• Last updated: 2025-11-17

Locations

1 site across 1 country: Egypt