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NCT Number: NCT07199816

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

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

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Key information

Conditions

Failed Back Surgery Syndrome (FBSS) Agnosia Back Pain Failed Back Surgery Syndrome Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pain Pathologic Processes Pathological Conditions, Signs and Symptoms Perceptual Disorders Postoperative Complications Signs and Symptoms

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kasr Al-Ainy Medical School, Cairo University

Cairo, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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 .

Treatment and study plan

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.

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.

Primary outcomes

  1. Pain intensity (Numerical Rating Scale - NRS)

    Time frame: 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 outcomes

  1. Postoperative pain intensity (NRS)

    Time frame: 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.

  2. Time to first postoperative analgesic request

    Time frame: 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.

  3. Total postoperative morphine consumption

    Time frame: 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.

  4. Analgesic efficacy based on WHO pain relief criteria

    Time frame: 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.

  5. Health-related quality of life assessed using the EuroQol EQ-5D-5L questionnaire

    Time frame: 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.

  6. Length of hospital stay

    Time frame: 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.

  7. Incidence of complications related to the blocks

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Hebatullah Mohammed Abdelmageed

Other

Collaborators

  • Cairo University

Registry information

Official study title

The Analgesic Effect of Caudal Epidural Versus Combined Lumbar Sympathetic Block With Caudal Epidural in Patients Undergoing Redo Lumbar Surgery: A Randomized Double Blinded Controlled Trial.

Acronym: CLEARS

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Sep 30, 2025
Registry last updated
Jul 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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