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

Not Applicable

Recruiting

• Conditions: Pain Management; Postoperative Acute Pain; Chronic Back Pain
• Interventions: Procedure: Ultrasound-guided spinal anesthesia; Drug: Midazolam plus ultrasound-guided spinal anesthesia; Procedure: Landmark-guided spinal anesthesia

• Registration Number: NCT07198412
• Lead Sponsor: Benha University

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.

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.

Study Timeline

• Status Verified: 2025-09
• Study Start: 2025-09-10
• Study First Submitted: 2025-09-15
• Study First Submitted QC: 2025-09-21
• Last Update Submitted: 2025-09-21
• Study First Posted: 2025-09-30
• Last Update Posted: 2025-09-30
• Primary Completion: 2026-04-10
• Study Completion: 2026-05-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 180

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)	Ultrasound-guided spinal anesthesia	-
Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)	Midazolam plus ultrasound-guided spinal anesthesia	-
Arm C - Landmark-Guided Spinal Anesthesia (Control)	Landmark-guided spinal anesthesia	-

Primary Outcome Measures

Name	Time	Method
Incidence of Postoperative Back Pain	24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery	Presence of pain or discomfort at the lower back or puncture site, assessed using a pain body map and Numeric Rating Scale (0-10). Evaluations will be performed both in the early postoperative period and during follow-up.

Secondary Outcome Measures

Name	Time	Method
Severity of Postoperative Back Pain	24-48 hours; 1 month, 3 months, and 6 months postoperatively	Intensity of back pain rated using the Numeric Rating Scale (0-10).
Number of Needle Insertion Attempts	During the procedure	Documented as single attempt versus multiple attempts (\>2).
Patient Satisfaction	24 hours postoperatively	Patient-reported satisfaction assessed using a 5-point Likert scale.
Procedure-Related Complications	Within 7 days postoperatively	Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits.

Trial Locations

Locations (1)

Benha University Hospital; 🇪🇬 Banhā, Qalyubia Governorate, Egypt