Chronic Back Pain, Pain Management, Postoperative Acute Pain
Conditions
Keywords
Spinal anesthesia, Ultrasound-guided anesthesia, Pre-procedure sedation, Midazolam, Chronic back pain
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.
Interventions
PROCEDUREUltrasound-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).
DRUGMidazolam 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.
PROCEDURELandmark-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.
Sponsors
Benha University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of Postoperative Back Pain | 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
| Measure | Time frame | Description |
|---|---|---|
| Severity of Postoperative Back Pain | 24-48 hours; 1 month, 3 months, and 6 months postoperatively | Intensity of back pain rated using the Numeric Rating Scale (0-10). |
| Number of Needle Insertion Attempts | During the procedure | Documented as single attempt versus multiple attempts (\>2). |
| Patient Satisfaction | 24 hours postoperatively | Patient-reported satisfaction assessed using a 5-point Likert scale. |
| Procedure-Related Complications | Within 7 days postoperatively | Incidence of post-dural puncture headache, nausea, vomiting, urinary retention, or neurological deficits. |
Countries
Egypt
Contacts
Primary ContactSamar R Amin, M.D.
Outcome results
None listed