Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery.
To evaluate the improvement in pain score using numerical rate scale (NRS) over 4 months and compare this between the two groups. * To assess and compare the improvement of motor activity and early ambulation using EuroQo lmeasure (EQ-5D) between the two groups. * To evaluate and compare the overall patient satisfaction between the two groups.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
64
Under fluoroscopic guidance, the patient in the prone position will receive a caudal epidural injection through the sacral hiatus. A 22-gauge, 3.5-inch spinal needle (Spinocan®, BRAUN) is used to inject 1 mL of contrast media (Omnipaque 300) to confirm correct needle placement. Then, 10 mL of treatment solution (8 mL of 0.5% lidocaine and 2 mL of 8 mg dexamethasone) is administered.
Patients will receive both a caudal epidural block and a lumbar sympathetic ganglion block (LSGB) under fluoroscopic guidance. The LSGB is performed at the L2 or L3 vertebral body on the affected side using a 21-gauge Chiba needle. After confirming needle position with contrast imaging, 10 mL of solution (2 mL of 8 mg dexamethasone + 8 mL of 1% lidocaine) is injected. A caudal block is then performed as described above.
Kasr Al-Ainy Medical School, Cairo University
Cairo, Egypt
Pain intensity (Numerical Rating Scale - NRS)
Pain intensity will be assessed using the Numerical Rating Scale (NRS), where patients rate their pain from 0 (no pain) to 10 (worst possible pain). NRS scores will be compared between the two groups (caudal epidural block vs. combined lumbar sympathetic and caudal epidural block) to evaluate the long-term effectiveness of the interventions.
Time frame: Baseline and 3 months postoperative
Postoperative pain intensity (NRS)
Pain will be measured using the Numerical Rating Scale (NRS), where 0 = no pain and 10 = worst pain imaginable. Pain scores will be recorded preoperative and at 6, 12, 18, and 24 hours postoperatively to assess short-term pain control.
Time frame: Baseline, 1 week, 1month, and 2 months after surgery
Time to first postoperative analgesic request
Time (in hours) from the end of the procedure to the first request for analgesia. A longer time indicates more effective initial pain relief.
Time frame: from the end of surgery up to 24 hours after surgery
Total postoperative morphine consumption
Total amount of morphine administered postoperatively will be recorded in milligrams to evaluate analgesic requirement across both groups.
Time frame: During the first 24 hours after surgery
Analgesic efficacy based on WHO pain relief criteria
Pain relief will be categorized based on WHO four-grade scale: Complete Remission (CR), Partial Remission (PR), Mild Remission (MR), and No Response (NR), assessed at 3 months to evaluate long-term analgesic effect.
Time frame: 3 months after the surgery
Health-related quality of life assessed using the EuroQol EQ-5D-5L questionnaire
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The EuroQol (EQ-5D) questionnaire will be used to assess functional status and early ambulation at multiple follow-up points. Higher scores reflect better recovery and quality of life.
Time frame: Baseline, 1 week, 2 weeks, 1 month, 2 months, and 3 months after surgery
Length of hospital stay
Total number of days the patient remains hospitalized will be recorded to evaluate the effect of the intervention on recovery time.
Time frame: Through hospital discharge, an average of 3 days
Incidence of complications related to the blocks
Any adverse events or complications related to caudal epidural or lumbar sympathetic ganglion blocks (e.g., infection, hematoma, neurologic symptoms) will be recorded and compared between groups.
Time frame: From block administration through hospital discharge, an average of 3 days