Primary Osteoarthritis of Knee NosNCT03232957
Intrathecal Morphine for Unilateral Total Knee Arthroplasty
A study testing 50 ug IT morphine, 100 ug IT morphine and No IT morphine in people with Primary Osteoarthritis of Knee Nos, run by Mahidol University at 1 site in Thailand.
Trial summary
This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Osteoarthritis of Knee Nos
- What is being tested?
- 50 ug IT morphine, 100 ug IT morphine and No IT morphine
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 131 participants
- Where
- 1 siteThailand
- Study dates
- 1 Aug 2017to 31 Jul 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged more than 18 years old undergoing unilateral total knee arthroplasty
- American Society of Anesthesiologists physical status classification 1-3
Who cannot join
- Participants deny to enroll the study
- Allergy to local anesthetics, opioid and NSAIDs
- Hepatic disease
- Contraindication for neuraxial block or adductor canal block
- Uncontrolled cardiovascular disease
- Creatinine clearance less than 50 ml/min
Trial locations and contacts
1 site in 1 country.
Thailand1 site
Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, 10700
About this study
Official title: Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty
This study evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.
Read the detailed description
Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.
This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.
- Conditions
- Primary Osteoarthritis of Knee Nos
- Being tested
- 50 ug IT morphine, 100 ug IT morphine, No IT morphine, Morphine, Bupivacaine
- Keywords
- Intrathecal morphine, total knee arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
50 ug IT morphineProcedure or surgery
Spinal block with bupivacaine and intrathecal morphine 50 ug
100 ug IT morphineProcedure or surgery
Spinal block with bupivacaine and intrathecal morphine 100 ug
No IT morphineProcedure or surgery
Spinal block with bupivacaine and intrathecal morphine 0 ug
MorphineDrug
intrathecal morphine
BupivacaineDrug
0.5 isobaric bupivacaine
| Study group | Role | What they receive |
|---|---|---|
| No IT morphine | Experimental | Spinal block with 0.5% isobaric with no intrathecal morphine Receives: Procedure: No IT morphine; Drug: Morphine; Drug: Bupivacaine |
| 50 ug IT morphine | Experimental | Spinal block with 0.5% isobaric with 50 ug intrathecal morphine Receives: Procedure: 50 ug IT morphine; Drug: Morphine; Drug: Bupivacaine |
| 100 ug IT morphine | Experimental | Spinal block with 0.5% isobaric with 100 ug intrathecal morphine Receives: Procedure: 100 ug IT morphine; Drug: Morphine; Drug: Bupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numerical rating scale
Numerical rating scale 0-10
Measured: Within 48 hours
Secondary outcomes (3)
Morphine requirement
Systemic morphine requirement
Measured: Within 48 hours
Nausea vomiting
Incidence and severity of nausea and vomiting
Measured: Within 48 hours
Pruritus
Incidence and severity of pruritus
Measured: Within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2017
- Study start1 Aug 2017
- Primary completion1 Feb 2019
- Study completion31 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Primary Osteoarthritis of Knee NosStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 131 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mahidol University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Suwimon Tangwiwat, Mahidol University
- Investigators
- Suwimon Tangwiwat, MD, Principal investigator, Siriraj Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03232957
- Sponsor's protocol ID
- Si 331/2017
- Status last verified
- May 2021
- First submitted
- 26 Jul 2017
- Last updated
- 24 May 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. doi: 10.1177/230949901402200324.
PubMed 25550024Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.
PubMed 14570664Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.
PubMed 24025284Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
PubMed 18816386Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.
PubMed 24403757McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.
PubMed 24399578Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202.
PubMed 24765899
Study at a glance
From the registry record, last updated by the sponsor on 24 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT03232957
- Acronym / sponsor ID
- Si 331/2017
- Conditions
- Primary Osteoarthritis of Knee Nos
- Keywords
- Intrathecal morphine, total knee arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 131 participants (actual)
- Lead sponsor
- Mahidol UniversityUniversity, hospital or other
- Study start
- 1 Aug 2017 (actual)
- Primary completion
- 1 Feb 2019 (actual)
- Study completion
- 31 Jul 2019 (actual)
- First posted
- 28 Jul 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 evaluates postoperative numerical pain score and systemic opioid requirement within 48 hours for unilateral total knee arthroplasty. Comparing among 3 groups of intrathecal morphine; 0,50, 100 ug with multimodal analgesia.
Detailed description
Intrathecal opioid is effective postoperative analgesia for orthopedic lower extremity surgery. However there are some limitations such as nausea, vomiting, pruritus, dizziness. Nowadays multimodal analgesia is used in unilateral total knee arthroplasty include oral analgesic drugs, adductor canal block and local analgesia infiltration.
This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| No IT morphine | Experimental | Procedure: No IT morphine, Drug: Morphine, Drug: BupivacaineSpinal block with 0.5% isobaric with no intrathecal morphine |
| 50 ug IT morphine | Experimental | Procedure: 50 ug IT morphine, Drug: Morphine, Drug: BupivacaineSpinal block with 0.5% isobaric with 50 ug intrathecal morphine |
| 100 ug IT morphine | Experimental | Procedure: 100 ug IT morphine, Drug: Morphine, Drug: BupivacaineSpinal block with 0.5% isobaric with 100 ug intrathecal morphine |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Aged more than 18 years old undergoing unilateral total knee arthroplasty
- American Society of Anesthesiologists physical status classification 1-3
Key exclusion criteria (6 listed)
- Participants deny to enroll the study
- Allergy to local anesthetics, opioid and NSAIDs
- Hepatic disease
- Contraindication for neuraxial block or adductor canal block
- Uncontrolled cardiovascular disease
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 |
|---|---|---|
| 50 ug IT morphineSpinal block with bupivacaine and intrathecal morphine 50 ug | Procedure or surgery | 50 ug IT morphine |
| 100 ug IT morphineSpinal block with bupivacaine and intrathecal morphine 100 ug | Procedure or surgery | 100 ug IT morphine |
| No IT morphineSpinal block with bupivacaine and intrathecal morphine 0 ug | Procedure or surgery | No IT morphine |
| Morphineintrathecal morphine | Drug | 100 ug IT morphine, 50 ug IT morphine, No IT morphine |
| Bupivacaine0.5 isobaric bupivacaine | Drug | 100 ug IT morphine, 50 ug IT morphine, No IT morphine |
Primary outcome
Numerical rating scale
Time frame: Within 48 hours
Numerical rating scale 0-10
3 secondary outcomes
Morphine requirement
Time frame: Within 48 hours
Nausea vomiting
Time frame: Within 48 hours
Pruritus
Time frame: Within 48 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 May 2021.
- Background: PubMed 25550024Stowers MD, Lemanu DP, Coleman B, Hill AG, Munro JT. Review article: Perioperative care in enhanced recovery for total hip and knee arthroplasty. J Orthop Surg (Hong Kong). 2014 Dec;22(3):383-92. doi: 10.1177/230949901402200324.
- Background: PubMed 14570664Rathmell JP, Pino CA, Taylor R, Patrin T, Viani BA. Intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after hip and knee arthroplasty. Anesth Analg. 2003 Nov;97(5):1452-1457. doi: 10.1213/01.ANE.0000083374.44039.9E.
- Background: PubMed 24025284Ibrahim MS, Alazzawi S, Nizam I, Haddad FS. An evidence-based review of enhanced recovery interventions in knee replacement surgery. Ann R Coll Surg Engl. 2013 Sep;95(6):386-9. doi: 10.1308/003588413X13629960046435.
- Background: PubMed 18816386Hassett P, Ansari B, Gnanamoorthy P, Kinirons B, Laffey JG. Determination Of The Efficacy And Side-effect Profile Of Lower Doses Of Intrathecal Morphine In Patients Undergoing Total Knee Arthroplasty. BMC Anesthesiol. 2008 Sep 24;8:5. doi: 10.1186/1471-2253-8-5.
- Background: PubMed 24403757Nakai T, Tamaki M, Nakamura T, Nakai T, Onishi A, Hashimoto K. Controlling pain after total knee arthroplasty using a multimodal protocol with local periarticular injections. J Orthop. 2013 Mar 17;10(2):92-4. doi: 10.1016/j.jor.2013.02.001. eCollection 2013.
- Background: PubMed 24399578McCartney CJ, Nelligan K. Postoperative pain management after total knee arthroplasty in elderly patients: treatment options. Drugs Aging. 2014 Feb;31(2):83-91. doi: 10.1007/s40266-013-0148-y.
- Background: PubMed 24765899Kunopart M, Chanthong P, Thongpolswat N, Intiyanaravut T, Pethuahong C. Effects of single shot femoral nerve block combined with intrathecal morphine for postoperative analgesia: a randomized, controlled, dose-ranging study after total knee arthroplasty. J Med Assoc Thai. 2014 Feb;97(2):195-202.
- Individual participant dataSharing planned: No
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.
Suwimon Tangwiwat, MD principal investigator
Siriraj Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 50 ug IT morphine, 100 ug IT morphine and No IT morphine in people with Primary Osteoarthritis of Knee Nos, run by Mahidol University at 1 site in Thailand.
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 6 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: finished, as of the sponsor's last update on 24 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Numerical rating scale (time frame: Within 48 hours). 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 NCT03232957, which also lists 7 linked publications.
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 24 May 2021; AzTrials last refreshed its copy on 1 Nov 2026.