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

NCT ID: NCT07198412

Last Updated: 2025-11-17

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 180 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-10-01
• Study Completion Date: 2026-05-10

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.

Conditions

Pain Management; Postoperative Acute Pain; Chronic Back Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

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

Group Type: ACTIVE_COMPARATOR

Ultrasound-guided spinal anesthesia

Intervention Type: 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 B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)

Group Type: EXPERIMENTAL

Midazolam plus ultrasound-guided spinal anesthesia

Intervention Type: 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 C - Landmark-Guided Spinal Anesthesia (Control)

Group Type: PLACEBO_COMPARATOR

Landmark-guided spinal anesthesia

Intervention Type: 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.

Interventions

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).

Intervention Type: PROCEDURE

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.

Intervention Type: DRUG

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.

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Benha University

OTHER

Sponsor Role: lead

Responsible Party

Samar Rafik Mohamed Amin

Assistant professor of anesthesia and intensive care

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Benha University Hospital

Banhā, Qalyubia Governorate, Egypt

Site Status: RECRUITING

Countries

Egypt

Central Contacts

Samar R Amin, M.D.

Role: CONTACT

samar.rafik@gmail.com

+201287793991

Facility Contacts

Samar R Amin, MD

Role: primary

samar.rafik@gmail.com

+201287793991

Other Identifiers

RC_7.8.2025

Identifier Type: -

Identifier Source: org_study_id