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Recruiting NCT07198412

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

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Clinical Trial Summary
NCT ID NCT07198412
Status Recruiting
Phase
Sponsor Benha University
Condition Pain Management
Study Type INTERVENTIONAL
Enrollment 180 participants
Start Date 2025-10-01
Primary Completion 2026-04-10

Eligibility & Interventions

Sex All sexes
Min Age 18 Years
Max Age 65 Years
Study Type INTERVENTIONAL
Interventions
Ultrasound-guided spinal anesthesiaMidazolam plus ultrasound-guided spinal anesthesiaLandmark-guided spinal anesthesia

Eligibility Fast-Check

Enter your details for a quick preliminary check. This does not replace medical advice.

What to Expect as a Participant

You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.

This trial targets 180 participants in total. It began in 2025-10-01 with a primary completion date of 2026-04-10.

⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.

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.

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

Contact & Investigator

Central Contact

Samar R Amin, M.D.

✉ samar.rafik@gmail.com

📞 +201287793991

Frequently Asked Questions

Who can join the NCT07198412 clinical trial?

This trial is open to participants of all sexes, aged 18 Years or older, up to 65 Years, studying Pain Management. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.

Is NCT07198412 currently recruiting?

Yes, NCT07198412 is actively recruiting participants. Contact the research team at samar.rafik@gmail.com for enrollment information.

Where is the NCT07198412 trial being conducted?

This trial is being conducted at Banhā, Egypt.

Who is sponsoring the NCT07198412 clinical trial?

NCT07198412 is sponsored by Benha University. The trial plans to enroll 180 participants.

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ClinicalMetric — Independent clinical trial intelligence platform. Not affiliated with NIH, ClinicalTrials.gov, the U.S. FDA, or any pharmaceutical company, hospital, or clinical research organization. Trial data is sourced from ClinicalTrials.gov for informational purposes only and does not constitute medical advice. Do not make any treatment, enrollment, or health decisions based solely on information found here — always consult a qualified healthcare professional. Full Disclaimer  ·  Last Reviewed: April 2026  ·  Data Methodology