Tokyo, Jan. 10 -- UMIN Clinical Trials Registry (UMIN-CTR) received information related to the study (UMIN000060238) titled 'Caudal Epidural Block with Morphin for Postoperative Analgesia in LSS' on Jan. 10.

Study Type: Interventional

Study Design: Basic Design - Parallel Randomization - Randomized Blinding - Double blind -all involved are blinded Control - Placebo

Primary Sponsor: Institute - Ijinkai Takeda General Hospital

Condition: Condition - Lumbar Spinal Stenosis Classification by malignancy - Others Genomic information - NO

Objective: Narrative objectives1 - To clarify the efficacy of a single-dose sacral epidural block using morphine hydrochloride and ropivacaine administered intraoperatively (immediately before skin incision after general anesthesia) during microsurgical spinal canal enlargement for spinal canal stenosis in controlling postoperative pain. Basic objectives2 - Safety,Efficacy

Intervention: Interventions/Control_1 - Drug administration group: Sacral epidural block using a mixture of 5mg/0.5ml morphine hydrochloride and 19.5ml saline solution (20ml total) One shot administered immediately before surgery Interventions/Control_2 - Placebo group: 20 ml saline solution administered via sacral epidural injection One shot administered immediately before surgery

Eligibility: Age-lower limit - 50 years-old = Gender - Male and Female Key inclusion criteria - 1. Patients undergoing microscopic spinal decompression for one or two intervertebral segments lumbar spinal stenosis between the third lumbar vertebra and the first sacral vertebra 2. American Society of Anesthesiologists (ASA) physical status grade 2 or lower Key exclusion criteria - 1. Planned reoperation cases, reoperation cases for adjacent segment disorders following prior surgery 2. Emergency surgery cases 3. Lumbar spinal stenosis cases due to spinal or spinal cord tumors 4. Cases with spinal infections, including spinal tuberculosis 5. Lumbar spinal stenosis cases associated with vertebral fractures 6. Cases receiving preoperative opioid administration 7. Cases with a history of hypersensitivity to water-soluble morphine Target Size - 72

Recruitment Status: Recruitment status - Enrolling by invitation Date of protocol fixation - 2025 Year 12 Month 01 Day Date of IRB - 2025 Year 12 Month 09 Day Anticipated trial start date - 2026 Year 01 Month 15 Day Last follow-up date - 2028 Year 12 Month 31 Day

To know more, visit https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067591

Disclaimer: Curated by HT Syndication.