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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
180
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).
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.
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.
Benha University Hospital
Banhā, Qalyubia Governorate, Egypt
RECRUITINGIncidence 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
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
Number of Needle Insertion Attempts
Documented as single attempt versus multiple attempts (\>2).
Time frame: During the procedure
Patient Satisfaction
Patient-reported satisfaction assessed using a 5-point Likert scale.
Time frame: 24 hours postoperatively
Procedure-Related Complications
Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits.
Time frame: Within 7 days postoperatively
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