Failed Back Surgery Syndrome (FBSS)
Conditions
Keywords
Caudal Epidural Injection, Failed Back Surgery Syndrome, Pain Management, Analgesia
Brief summary
Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery.
Detailed description
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.
Interventions
PROCEDUREFluoroscopy-Guided Caudal Epidural Block
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.
PROCEDURECombined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
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.
Sponsors
Hebatullah Mohammed Abdelmageed
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)
Eligibility
Sex/Gender
ALL
Age
40 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
* Age 40-70 years. * Both sexes. * American Society of Anesthesiologists (ASA) physical status I to III. * Undergoing lumbar spine surgery level L4-5/ L5-S1 for the second time. * Duration of chronic low back pain \> 3months.
Exclusion criteria
* Emergency surgeries. * Bleeding disorder. * patient refusal for the procedure. * Pregnancy. * Neoplastic diseases, allergies to contrast. * Liver failure or kidney failure .
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (Numerical Rating Scale - NRS) | Baseline and 3 months postoperative | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity (NRS) | Baseline, 1 week, 1month, and 2 months after surgery | 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 to first postoperative analgesic request | from the end of surgery up to 24 hours after surgery | Time (in hours) from the end of the procedure to the first request for analgesia. A longer time indicates more effective initial pain relief. |
| Total postoperative morphine consumption | During the first 24 hours after surgery | Total amount of morphine administered postoperatively will be recorded in milligrams to evaluate analgesic requirement across both groups. |
| Analgesic efficacy based on WHO pain relief criteria | 3 months after the surgery | 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. |
| Health-related quality of life assessed using the EuroQol EQ-5D-5L questionnaire | Baseline, 1 week, 2 weeks, 1 month, 2 months, and 3 months after surgery | 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. |
| Length of hospital stay | Through hospital discharge, an average of 3 days | Total number of days the patient remains hospitalized will be recorded to evaluate the effect of the intervention on recovery time. |
| Incidence of complications related to the blocks | From block administration through hospital discharge, an average of 3 days | 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. |
Countries
Egypt
Outcome results
None listed