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

NCT07198412 | Recruiting

• 1 other identifier: RC_7.8.2025
• Study Type: interventional
• Target: 180
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain Management; Postoperative Acute Pain; Chronic Back Pain

Keywords

Spinal anesthesia; Ultrasound-guided anesthesia; Pre-procedure sedation; Midazolam; Chronic back pain

Outcome Measures

Primary Outcomes (1)

• Incidence of Postoperative Back Pain

  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.

  24-48 hours postoperatively; 1 month, 3 months, and 6 months after surgery

Secondary Outcomes (4)

• Severity of Postoperative Back Pain

  24-48 hours; 1 month, 3 months, and 6 months postoperatively

• Number of Needle Insertion Attempts

  During the procedure

• Patient Satisfaction

  24 hours postoperatively

• Procedure-Related Complications

  Within 7 days postoperatively

Study Arms (3)

Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)

ACTIVE COMPARATOR

Procedure: Ultrasound-guided spinal anesthesia

Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)

EXPERIMENTAL

Drug: Midazolam plus ultrasound-guided spinal anesthesia

Arm C - Landmark-Guided Spinal Anesthesia (Control)

PLACEBO COMPARATOR

Procedure: Landmark-guided spinal anesthesia

Interventions

Ultrasound-guided spinal anesthesia PROCEDURE

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).

Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)

Midazolam plus ultrasound-guided spinal anesthesia DRUG

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.

Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)

Landmark-guided spinal anesthesia PROCEDURE

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.

Arm C - Landmark-Guided Spinal Anesthesia (Control)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Benha University: lead

Study Sites (1)

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

RECRUITING

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Midazolam

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Benzodiazepines; Benzazepines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Central Study Contacts

Samar R Amin, M.D.

CONTACT

+201287793991; samar.rafik@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor of anesthesia and intensive care

Study Record Dates

• First Submitted: September 15, 2025
• First Posted: September 30, 2025
• Study Start: October 1, 2025
• Primary Completion: April 10, 2026
• Study Completion (Estimated): May 10, 2026
• Last Updated: November 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)