Caudal Epidural With or Without Lumbar Sympathetic Block for Redo Lumbar Surgery

NCT07199816 | Completed DMC

• 1 other identifier: N- 26- 2024/ MD
• Study Type: interventional
• Target: 64
• Locations: 1 country
• Sites: 1

Brief Summary

Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery.

Conditions

Failed Back Surgery Syndrome (FBSS)

Keywords

Caudal Epidural Injection; Failed Back Surgery Syndrome; Pain Management; Analgesia

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and 3 months postoperative

Secondary Outcomes (7)

• Postoperative pain intensity (NRS)

  Baseline, 1 week, 1month, and 2 months after surgery

• Time to first postoperative analgesic request

  from the end of surgery up to 24 hours after surgery

• Total postoperative morphine consumption

  During the first 24 hours after surgery

• Analgesic efficacy based on WHO pain relief criteria

  3 months after the surgery

• 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

Study Arms (2)

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.

Procedure: Fluoroscopy-Guided Caudal Epidural Block

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.

Procedure: Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block

Interventions

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.

Group C

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.

Group LC

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Emergency surgeries.
• Bleeding disorder.
• patient refusal for the procedure.
• Pregnancy.
• Neoplastic diseases, allergies to contrast.
• Liver failure or kidney failure .

Sponsors & Collaborators

• Cairo University: collaborator
• Hebatullah Mohammed Abdelmageed: lead

Study Sites (1)

Kasr Al-Ainy Medical School, Cairo University

Cairo, Egypt

Location

Related Links

• Related Info

MeSH Terms

Conditions

Failed Back Surgery Syndrome; Agnosia

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Back Pain; Pain; Neurologic Manifestations; Signs and Symptoms; Perceptual Disorders; Neurobehavioral Manifestations; Nervous System Diseases

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Assistant Lecturer of Anesthesiology

Study Record Dates

• First Submitted: September 14, 2025
• First Posted: September 30, 2025
• Study Start: March 1, 2024
• Primary Completion: February 1, 2026
• Study Completion: February 1, 2026
• Last Updated: July 14, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)