UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060238 |
|---|---|
| Receipt number | R000067591 |
| Scientific Title | 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 |
| Date of disclosure of the study information | 2026/01/10 |
| Last modified on | 2025/12/30 15:35:13 |
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Basic information
Public title
Caudal Epidural Block with Morphin for Postoperative Analgesia in LSS
Acronym
EBM-PAinLeSS study
Scientific Title
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
Scientific Title:Acronym
EBM-PAinLeSS study
Region
| Japan |
Condition
Condition
Lumbar Spinal Stenosis
Classification by specialty
| Orthopedics | Neurosurgery |
Classification by malignancy
Others
Genomic information
NO
Objectives
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
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
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
Key secondary outcomes
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
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Cluster
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
YES
Dynamic allocation
NO
Institution consideration
Institution is not considered as adjustment factor.
Blocking
YES
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
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
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 50 | years-old | <= |
Age-upper limit
| 85 | 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 sample size
72
Research contact person
Name of lead principal investigator
| 1st name | Naokado |
| Middle name | |
| Last name | Ikeda |
Organization
Ijinkai Takeda General Hospital
Division name
Department of Neurosurgery
Zip code
601-1495
Address
28-1 Ishidamori minami-cho, Fushimi-Ku, Kyoto
TEL
+81-75-572-6331
naokado.ikeda@ompu.ac.jp
Public contact
Name of contact person
| 1st name | Kunio |
| Middle name | |
| Last name | Yokoyama |
Organization
Ijinkai Takeda General Hospital
Division name
Department of Neurosurgery
Zip code
601-1495
Address
28-1 Ishidamori minami-cho, Fushimi-Ku, Kyoto
TEL
+81-75-572-6331
Homepage URL
https://www.takedahp.or.jp/ijinkai/cooperation/clinical_research/
kunio.yokoyama@ompu.ac.jp
Sponsor or person
Institute
Ijinkai Takeda General Hospital
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Ijinkai Takeda General Hospital, Clinical Research Center
Address
28-1 Ishidamori minami-cho, Fushimi-ku, Kyoto
Tel
+81-75-572-6331
mtsnaruse@nifty.com
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
医仁会武田総合病院 (京都府）
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 01 | Month | 10 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
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 |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 12 | Month | 30 | Day |
Last modified on
| 2025 | Year | 12 | Month | 30 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000067591
