UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000060941 |
|---|---|
| Receipt number | R000069738 |
| Scientific Title | Low-Dose Intrathecal Morphine in Multilevel Lumbar Spine Surgery: A Randomized Controlled Trial. |
| Date of disclosure of the study information | 2026/03/15 |
| Last modified on | 2026/03/15 23:29:45 |
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Basic information
Public title
A Study on Using Low-Dose Morphine During Complex Lower Back Surgery
Acronym
A Study on Using Low-Dose Morphine During Complex Lower Back Surgery
Scientific Title
Low-Dose Intrathecal Morphine in Multilevel Lumbar Spine Surgery: A Randomized Controlled Trial.
Scientific Title:Acronym
Low-Dose Intrathecal Morphine in Multilevel Lumbar Spine Surgery: A Randomized Controlled Trial.
Region
| Asia(except Japan) |
Condition
Condition
Pain after complex spine surgery
Classification by specialty
| Surgery in general | Anesthesiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
to test that low-dose ITM would significantly reduce perioperative systemic opioid consumption, improve pain scores, and increase patient satisfaction, without a significant increase in opioid-related adverse effects
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Phase IV
Assessment
Primary outcomes
The primary outcome was the total dose of morphine consumed (via PCA) over the first 48 hours postoperatively
Key secondary outcomes
Secondary outcomes included VAS (score 0 = no pain, 10 = worst pain ever) at 1, 6, 18, 24, 36 and 48 hours after extubation, total intraoperative fentanyl consumption. Time to the first analgesic request was measured from extubation until the patient called for rescue analgesia. intraoperative heart rate (HR) and mean arterial blood pressure (MAP) before and after induction, after skin incision, 2 hours after skin incision and at skin closure were all recorded. Secondary outcomes also included postoperative HR, and MAP at 1, 6, 18, 24, 36 and 48 hours after extubation. Incidence of complications such as sedation, nausea, vomiting, pruritus, and respiratory depression were all recorded. Lastly, overall patient satisfaction was assessed 48 hours post-procedure using a 4-point ordinal scale with the response options: poor, satisfactory, very good, and excellent.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is considered as adjustment factor in dynamic allocation.
Blocking
YES
Concealment
Numbered container method
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Intervention Group: Low-dose Intrathecal Morphine (ITM)
Amount: 0.2 mg preservative-free morphine in 2 ml normal saline.
Route: Intrathecal injection at lumbar vertebral level L2-L3 using a 25 G pencil point spinal needle.
Frequency: Administered once after the induction of general anesthesia and prior to positioning for surgery.
Duration/Standard Care: Single intrathecal administration. Patients also receive standard general anesthesia. Prior to surgical closure, patients receive standardized multimodal analgesia (1 g IV paracetamol, 8 mg IV meloxicam, and subfascial infiltration with 20 ml of 0.5% bupivacaine). Postoperatively, patients are prescribed intravenous morphine patient-controlled analgesia (PCA) set at a 1 mg/ml concentration, delivering 1 mg boluses with a 10-minute lockout interval (maximum of 24 mg/4 hours).
Interventions/Control_2
Active Control Group: General Anesthesia Only (Control)
Amount/Route: Standard general anesthesia without any intrathecal intervention.
Frequency: Administered continuously for the duration of the surgery.
Duration/Standard Care: Patients in this group are turned to the prone position immediately after induction without receiving intrathecal medication. Prior to surgical closure, they receive the exact same standardized multimodal analgesia as the ITM group: 1 g IV paracetamol, 8 mg IV meloxicam, and subfascial infiltration with 20 ml of 0.5% bupivacaine. Postoperatively, they are also prescribed identical intravenous morphine patient-controlled analgesia (PCA) with 1 mg boluses and a 10-minute lockout interval for the first 48 hours.
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
| 8 | years-old | <= |
Age-upper limit
| 70 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
American Society of Anesthesiologists (ASA) physical status I or II, scheduled for elective lumbar spine surgery involving two or more levels
Key exclusion criteria
Exclusion criteria included refusal to participate, single-level procedure, minimally invasive, or revision surgery, history of hepatic or renal impairment, any contraindication to intrathecal injection (e.g., coagulopathy, local infection), known allergy to morphine and history of chronic opioid use or dependence
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Mohamed |
| Middle name | Ahmed |
| Last name | Sayedalahl |
Organization
King Abdullah Medical City
Division name
Anesthesia Department
Zip code
24246
Address
Saudi Arabia Makkah
TEL
+966538590998
sayedalahl700@mans.edu.eg
Public contact
Name of contact person
| 1st name | Mohamed |
| Middle name | Ahmed |
| Last name | Sayedalahl |
Organization
King Abdullah Medical City
Division name
Anesthesia Department
Zip code
24246
Address
Saudi Arabia Makkah
TEL
00966538590998
Homepage URL
sayedalahl700@mans.edu.eg
Sponsor or person
Institute
King Abdullah Medical City
Institute
Department
Personal name
Funding Source
Organization
King Abdullah Medical City
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
King Abdullah Medical City IRB
Address
Saudi Arabia Makkah
Tel
+966012 554 9999
IRB@kamc.med.sa
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
King Abdullah Medical City
Other administrative information
Date of disclosure of the study information
| 2026 | Year | 03 | Month | 15 | 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
Preinitiation
Date of protocol fixation
| 2023 | Year | 05 | Month | 28 | Day |
Date of IRB
Anticipated trial start date
| 2026 | Year | 05 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 05 | Month | 03 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2026 | Year | 03 | Month | 15 | Day |
Last modified on
| 2026 | Year | 03 | Month | 15 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000069738
