Pain Control With Caudal Epidural vs. Combined Caudal Epidural and Lumbar Sympathetic Block . (CLEARS)

Hebatullah Mohammed Abdelmageed

Status: Active, not recruiting

Conditions: Pain Management After Surgery

Treatments: Procedure: Fluoroscopy-Guided Caudal Epidural Block; Procedure: Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block

Study type: Interventional

Funder types: Other

Identifiers

NCT07199816

N- 26- 2024/ MD

Details and patient eligibility

About

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

Full 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.

Enrollment: 64 estimated patients

Sex: All

Ages: 40 to 70 years old

Volunteers: No Healthy Volunteers

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 .

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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64 participants in 2 patient groups

Group C

Active Comparator group

Description:

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.

Treatment:

Procedure: Fluoroscopy-Guided Caudal Epidural Block

Group LC

Active Comparator group

Description:

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.

Treatment:

Procedure: Combined Lumbar Sympathetic Ganglion Block and Caudal Epidural Block