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NCT Number: NCT07198412

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

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.

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Key information

Conditions

Pain Management Agnosia Chronic Back Pain Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Acute Pain Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Benha University Hospital

Banhā, Qalyubia Governorate, 13511, Egypt

Location status: Recruiting

Location contact

Samar R Amin, MD

CONTACT

[email protected]

+201287793991

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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).

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.

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.

Primary outcomes

  1. Incidence of Postoperative Back Pain

    Time frame: 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 outcomes

  1. Severity of Postoperative Back Pain

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

    Intensity of back pain rated using the Numeric Rating Scale (0-10).

  2. Number of Needle Insertion Attempts

    Time frame: During the procedure

    Documented as single attempt versus multiple attempts (>2).

  3. Patient Satisfaction

    Time frame: 24 hours postoperatively

    Patient-reported satisfaction assessed using a 5-point Likert scale.

  4. Procedure-Related Complications

    Time frame: Within 7 days postoperatively

    Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits.

Study contacts

Contact information is provided by the study sponsor or research team.

Samar R Amin, M.D.

CONTACT

[email protected]

+201287793991

Sponsors and collaborators

Lead sponsor

Benha University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Nov 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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