Knee ArthroplastyNCT03365115
Intrathecal Morphine and Fentanyl for Knee Arthroplasty
A study testing Intrathecal morphine and Intrathecal fentanyl in people with Knee Arthroplasty, run by Keimyung University Dongsan Medical Center.
Trial summary
This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty. Read more about this study
- Who is it for?
- Ages 19 to 80 years
- Conditions the study is for
- Knee Arthroplasty
- What is being tested?
- Intrathecal morphine and Intrathecal fentanyl
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2018to 1 Feb 2019
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled total knee replacement under spinal anesthesia
- ASA I-III
Who cannot join
- Coagulopathy
- Heart disease
- Liver disease
- Kidney disease
- Infection
- Psychological disorder
Show all 11Show fewer
- Allergy to bupivacaine
- Allergy to morphine
- Allergy to fentanyl
- Inability to use patient-controlled analgesic device
- Opioids due to chronic pain
About this study
Official title: Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty
This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.
- Conditions
- Knee Arthroplasty
- Being tested
- Intrathecal morphine, Intrathecal fentanyl
- Keywords
- spinal anesthesia, morphine, fentanyl, pain, knee
- Medical subject headings
- Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intrathecal morphineDrug
Intrathecal morphine 100 mcg will be injected.
Intrathecal fentanylDrug
Intrathecal fentanyl 25 mcg will be injected.
| Study group | Role | What they receive |
|---|---|---|
| intrathecal fentanyl | Active comparator | Not described Receives: Drug: Intrathecal fentanyl |
| intrathecal morphine | Active comparator | Not described Receives: Drug: Intrathecal morphine |
| intrathecal morphine and fentantyl | Experimental | Not described Receives: Drug: Intrathecal morphine; Drug: Intrathecal fentanyl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain scores at 6 hour postoperatively
Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
Measured: At 6 hour postoperatively
Secondary outcomes (6)
Postoperative pain scores at 12 and 24 hour postoperatively
Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
Measured: At 12 and 24 hour postoperatively
Patient-controlled analgesic device requirements
The requirements of patient-controlled analgesic device will be measured. Morphine will be used for patient-controlled analgesic device. Total dose of morphine used at 6, 12, and 24 hour postoperatively will be measured.
Measured: At 6, 12, and 24 hour postoperatively
Number of participants with nausea
Measured: At 6, 12, and 24 hour postoperatively
Number of participants with vomiting
Measured: At 6, 12, and 24 hour postoperatively
Number of participants with pruritus
Measured: At 6, 12, and 24 hour postoperatively
Number of participants with respiratory depression
Measured: At 6, 12, and 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Dec 2017
- Study start1 Jan 2018 (estimated)
- Primary completion1 Jan 2019 (estimated)
- Study completion1 Feb 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Knee ArthroplastyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 111 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyun-Chang Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03365115
- Sponsor's protocol ID
- 201712001
- Status last verified
- Dec 2017
- First submitted
- 30 Nov 2017
- Last updated
- 7 Dec 2017
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Park SK, Lee J, Gim DY, Park J, Kim HC. Combined intrathecal fentanyl and morphine for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. BMC Anesthesiol. 2026 May 25;26(1):435. doi: 10.1186/s12871-026-03940-7.
PubMed 42185960
Study at a glance
From the registry record, last updated by the sponsor on 7 Dec 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Combined Intrathecal Morphine and Fentanyl in Patients Undergoing Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03365115
- Acronym / sponsor ID
- 201712001
- Conditions
- Knee Arthroplasty
- Keywords
- spinal anesthesia, morphine, fentanyl, pain, knee
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 111 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 1 Jan 2018 (estimated)
- Primary completion
- 1 Jan 2019 (estimated)
- Study completion
- 1 Feb 2019 (estimated)
- First posted
- 7 Dec 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is planned to investigate the efficacy of combined infusion of intrathecal morphine and fentanyl in patients undergoing total knee arthroplasty.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| intrathecal fentanyl | Active comparator | Drug: Intrathecal fentanyl |
| intrathecal morphine | Active comparator | Drug: Intrathecal morphine |
| intrathecal morphine and fentantyl | Experimental | Drug: Intrathecal morphine, Drug: Intrathecal fentanyl |
Who may qualify
- Ages
- 19 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients scheduled total knee replacement under spinal anesthesia
- ASA I-III
Key exclusion criteria (11 listed)
- Coagulopathy
- Heart disease
- Liver disease
- Kidney disease
- Infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Intrathecal morphineIntrathecal morphine 100 mcg will be injected. | Drug | intrathecal morphine, intrathecal morphine and fentantyl |
| Intrathecal fentanylIntrathecal fentanyl 25 mcg will be injected. | Drug | intrathecal fentanyl, intrathecal morphine and fentantyl |
Primary outcome
Postoperative pain scores at 6 hour postoperatively
Time frame: At 6 hour postoperatively
Postoperative pain scores will be measured using visual-analogue scale (0:no pain, 10: worst imaginable pain).
6 secondary outcomes
Postoperative pain scores at 12 and 24 hour postoperatively
Time frame: At 12 and 24 hour postoperatively
Patient-controlled analgesic device requirements
Time frame: At 6, 12, and 24 hour postoperatively
Number of participants with nausea
Time frame: At 6, 12, and 24 hour postoperatively
Number of participants with vomiting
Time frame: At 6, 12, and 24 hour postoperatively
Number of participants with pruritus
Time frame: At 6, 12, and 24 hour postoperatively
Number of participants with respiratory depression
Time frame: At 6, 12, and 24 hour postoperatively
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Dec 2017.
- Derived from this study: PubMed 42185960Park SK, Lee J, Gim DY, Park J, Kim HC. Combined intrathecal fentanyl and morphine for postoperative analgesia after total knee arthroplasty: a randomised controlled trial. BMC Anesthesiol. 2026 May 25;26(1):435. doi: 10.1186/s12871-026-03940-7.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Intrathecal morphine and Intrathecal fentanyl in people with Knee Arthroplasty, run by Keimyung University Dongsan Medical Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 7 Dec 2017. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain scores at 6 hour postoperatively (time frame: At 6 hour postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03365115, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Dec 2017.