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

NARecruitingINTERVENTIONAL
Enrollment

180

Participants

Timeline

Start Date

September 10, 2025

Primary Completion Date

April 10, 2026

Study Completion Date

May 10, 2026

Conditions
Pain ManagementPostoperative Acute PainChronic Back Pain
Interventions
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.

Trial Locations (1)

13511

RECRUITING

Benha University Hospital, Banhā

All Listed Sponsors
lead

Benha University

OTHER

NCT07198412 - Effect of Sedation After Ultrasound-Guided Spinal Anesthesia on Back Pain | Biotech Hunter | Biotech Hunter