Health TrialsbyHealthPanel

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

ConditionsPain ManagementPostoperative Acute PainChronic Back Pain
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBenha University

About this trial

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

This trial does not accept healthy volunteers

Qualifiers

None

Disqualifiers

None

Trial design

Design model

Parallel

Treatments tested in this trial

  • Ultrasound-guided spinal anesthesia

    Procedure/Surgery

    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/Surgery

    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.

Treatment groups

180 Participants
are divided into 3 treatment groups
Group A: Arm A - Ultrasound-Guided Spinal Anesthesia (No Sedation)Active comparator 1 intervention
Group B: Arm B - Ultrasound-Guided Spinal Anesthesia with Sedation (Midazolam)Experimental treatment 1 intervention
Group C: Arm C - Landmark-Guided Spinal Anesthesia (Control)Placebo comparator 1 intervention

Trial outcomes

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.

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

Secondary outcomes

1

Severity of Postoperative Back Pain

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

Time frame
24-48 hours; 1 month, 3 months, and 6 months postoperatively
2

Number of Needle Insertion Attempts

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

Time frame
During the procedure
3

Patient Satisfaction

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

Time frame
24 hours postoperatively
4

Procedure-Related Complications

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

Time frame
Within 7 days postoperatively

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Benha University

Lead sponsor

Source ClinicalTrials.gov
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