Failed Back Surgery Syndrome (FBSS)CLEARSNCT07199816
Caudal Epidural With or Without Lumbar Sympathetic Block for Redo Lumbar Surgery
A study testing Fluoroscopy-Guided Caudal Epidural Block and Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block in people with Failed Back Surgery Syndrome (FBSS), run by Hebatullah Mohammed Abdelmageed at 1 site in Egypt.
Trial summary
Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery. Read more about this study
- Who is it for?
- Ages 40 to 70 years
- Conditions the study is for
- Failed Back Surgery Syndrome (FBSS)
- What is being tested?
- Fluoroscopy-Guided Caudal Epidural Block and Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 64 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Mar 2024to 1 Feb 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- Emergency surgeries.
- Bleeding disorder.
- patient refusal for the procedure.
- Pregnancy.
- Neoplastic diseases, allergies to contrast.
- Liver failure or kidney failure .
Trial locations and contacts
1 site in 1 country.
About this study
Official 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.
Comparing the analgesic effect of caudal epidural versus combined lumbar sympathetic block with caudal epidural in patients undergoing redo spinal surgery.
Read the 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.
- Conditions
- Failed Back Surgery Syndrome (FBSS)
- Being tested
- Fluoroscopy-Guided Caudal Epidural Block, Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block
- Keywords
- Caudal Epidural Injection, Failed Back Surgery Syndrome, Pain Management, Analgesia
- Medical subject headings
- Failed Back Surgery Syndrome, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoroscopy-Guided Caudal Epidural BlockProcedure or surgery
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 BlockProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline and 3 months postoperative
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 3 months after the surgery
Health-related quality of life assessed using the EuroQol EQ-5D-5L questionnaire
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.
Measured: 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.
Measured: 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.
Measured: From block administration through hospital discharge, an average of 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2025
- Study start1 Mar 2024
- Primary completion1 Feb 2026
- Study completion1 Feb 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Failed Back Surgery Syndrome (FBSS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 64 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hebatullah Mohammed Abdelmageed
- Sponsor type
- University, hospital or other
- Collaborators
- Cairo University
- Responsible party
- Sponsor-investigator, Hebatullah Mohammed Abdelmageed, Kasr El Aini Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07199816
- Sponsor's protocol ID
- N- 26- 2024/ MD
- Acronym
- CLEARS
- Status last verified
- Jul 2026
- First submitted
- 14 Sep 2025
- Last updated
- 28 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Participant privacy and confidentiality concerns; data sharing is not permitted under institutional policy.
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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.
- ClinicalTrials.gov ID
- NCT07199816
- Acronym / sponsor ID
- CLEARS / N- 26- 2024/ MD
- Conditions
- Failed Back Surgery Syndrome (FBSS)
- Keywords
- Caudal Epidural Injection, Failed Back Surgery Syndrome, Pain Management, Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Hebatullah Mohammed AbdelmageedUniversity, hospital or other
- Collaborators
- Cairo University
- Study start
- 1 Mar 2024 (actual)
- Primary completion
- 1 Feb 2026 (actual)
- Study completion
- 1 Feb 2026 (actual)
- First posted
- 30 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group C | Active comparator | Procedure: Fluoroscopy-Guided Caudal Epidural BlockGroup 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. |
| Group LC | Active comparator | Procedure: Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural BlockGroup 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. |
Who may qualify
- Ages
- 40 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (6 listed)
- Emergency surgeries.
- Bleeding disorder.
- patient refusal for the procedure.
- Pregnancy.
- Neoplastic diseases, allergies to contrast.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoroscopy-Guided Caudal Epidural BlockUnder 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. | Procedure or surgery | Group C |
| Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural BlockPatients 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. | Procedure or surgery | Group LC |
Primary outcome
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.
7 secondary outcomes
Postoperative pain intensity (NRS)
Time frame: Baseline, 1 week, 1month, and 2 months after surgery
Time to first postoperative analgesic request
Time frame: from the end of surgery up to 24 hours after surgery
Total postoperative morphine consumption
Time frame: During the first 24 hours after surgery
Analgesic efficacy based on WHO pain relief criteria
Time frame: 3 months after the surgery
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
Length of hospital stay
Time frame: Through hospital discharge, an average of 3 days
Incidence of complications related to the blocks
Time frame: From block administration through hospital discharge, an average of 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: No. Participant privacy and confidentiality concerns; data sharing is not permitted under institutional policy.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Fluoroscopy-Guided Caudal Epidural Block and Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block in people with Failed Back Surgery Syndrome (FBSS), run by Hebatullah Mohammed Abdelmageed at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain intensity (Numerical Rating Scale - NRS) (time frame: Baseline and 3 months postoperative). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2026.