Skip to content

Caudal Epidural Block with Morphin for Postoperative Analgesia in LSS

Double-Blind Randomized Controlled Trial to Determine the Efficacy of Intraoperative Sacral Epidural Block for Postoperative Pain Control in Microsurgical Spinal Decompression for Lumbar Spinal Stenosis - EBM-PAinLeSS study

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
JPRN
Registry ID
JPRN-UMIN000060238
Enrollment
72
Registered
2026-01-10
Start date
2026-01-15
Completion date
Unknown
Last updated
2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lumbar Spinal Stenosis

Interventions

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 Placebo

Sponsors

Ijinkai Takeda General Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

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

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frame
1 Percentage of patients who did not require analgesics within 48 hours after extubation 2 Time from extubation to administration of rescue analgesics in patients who required them

Secondary

MeasureTime frame
1 Total intraoperative opioid analgesic administration excluding epidural preoperative administration 2 Post-extubation pain scale 3 Post-extubation pruritus scale 4 Postoperative nausea and vomiting scale

Countries

Japan

Contacts

Public ContactKunio Yokoyama

Ijinkai Takeda General Hospital Department of Neurosurgery

kunio.yokoyama@ompu.ac.jp+81-75-572-6331

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026