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| Name | Class |
|---|---|
| Cairo University | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group C | Active Comparator | Group C (n=32): this group will receive fluoroscopy guided caudal epidural block. Under fluoroscopic guidance and the patients in prone position, caudal epidural injection will be achieved. A pillow will be inserted under the pelvic bones for better exposure and accessibility of thesacral hiatus. Betadine will be used for sterilization of the sacrococcygeal area and palpation of the coccygeal tip. Upon localization of the sacral hiatus, a 22-gauge, 3.5-inch length spinal needle (Spinocan®, BRAUN, Melsungen, Germany) with the image intensifier will be used to inject 1 mL of contrast media (Omnipaque 300; GE Healthcare, Carrigtohill, Co. Cork, Ireland). After confirming the right needle position and excluding intravascular, intrathecal, and soft tissue infiltration, 10 cc of the treatment drug (8 ml of 0.5%lidocaine mixed with 2ml of 8 mg dexamethasone) will be injected. |
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| Group LC | Active Comparator | Group LC: Group (n=32): this group will receive combined fluoroscopy guided caudal epidural block and lumbar sympathetic ganglion block. Under fluoroscopic guidance, LSGB will be performed. The block level and side will be determined. Patients will be kept in the prone position while C-arm (GE OEC 9900 C- of the anteroposterior, oblique, and lateral view are examined to verify the correct entrance sit. The skin will be prepared in an aseptic manner. Approach the anterolateral border of the inferior sec of the L2 vertebral body or the upper portion of the L3 vertebral body of the affected side where the pain exists, using a 21-gauge Chiba needle. Following the confirmation of the needle location via fluoroscopic imaging, an aspiration test will be performed in order to rule out the presence of blood, following by injection of a contrast medium. Following that, 2 mL of 8mg dexamethasone will be diluted with 8 mL of 1% lidocaine and injected unilaterally at one level. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Fluoroscopy-Guided Caudal Epidural Block | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over 3 months postoperative |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | over 24 hours after surgery |
| Time to first postoperative analgesic request |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Kasr Al-Ainy Medical School, Cairo University | Cairo | Egypt |
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| Label | URL |
|---|---|
| Related Info | View source |
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Participant privacy and confidentiality concerns; data sharing is not permitted under institutional policy.
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| Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block | Procedure | 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. |
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Time (in hours) from the end of the procedure to the first request for analgesia. A longer time indicates more effective initial pain relief. |
| postoperative period up to hospital discharge |
| Total postoperative morphine consumption | Total amount of morphine administered postoperatively will be recorded in milligrams to evaluate analgesic requirement across both groups. | postoperative period up to hospital discharge |
| Long-term pain relief using 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. | over 3 months after the procedure |
| Functional recovery and ambulation (EuroQol) | 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. | over 3 months postoperative |
| 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. | From admission to discharge |
| 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. | Intraoperative and postoperative period up to hospital discharge |
| ID | Term |
|---|---|
| D000377 | Agnosia |
| ID | Term |
|---|---|
| D010468 | Perceptual Disorders |
| D019954 | Neurobehavioral Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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