Intrathecal Morphine for Unilateral Total Knee Arthroplasty
NCT ID: NCT03232957
Last Updated: 2021-05-24
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
131 participants
INTERVENTIONAL
2017-08-01
2019-07-31
Brief Summary
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Detailed Description
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This study evaluates whether intrathecal opioid should be added in the role of multimodal analgesia in total knee arthroplasty.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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No IT morphine
Spinal block with 0.5% isobaric with no intrathecal morphine
No IT morphine
Spinal block with bupivacaine and intrathecal morphine 0 ug
Morphine
intrathecal morphine
Bupivacaine
0.5 isobaric bupivacaine
50 ug IT morphine
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
50 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 50 ug
Morphine
intrathecal morphine
Bupivacaine
0.5 isobaric bupivacaine
100 ug IT morphine
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
100 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 100 ug
Morphine
intrathecal morphine
Bupivacaine
0.5 isobaric bupivacaine
Interventions
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50 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 50 ug
100 ug IT morphine
Spinal block with bupivacaine and intrathecal morphine 100 ug
No IT morphine
Spinal block with bupivacaine and intrathecal morphine 0 ug
Morphine
intrathecal morphine
Bupivacaine
0.5 isobaric bupivacaine
Eligibility Criteria
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Inclusion Criteria
* American Society of Anesthesiologists physical status classification 1-3
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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Mahidol University
OTHER
Responsible Party
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Suwimon Tangwiwat
Assistant professor, Department of Anesthesiology
Principal Investigators
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Suwimon Tangwiwat, MD
Role: PRINCIPAL_INVESTIGATOR
Siriraj Hospital
Locations
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Faculty of Medicine Siriraj Hospital, Mahidol University
Bangkok Noi, Bangkok, Thailand
Countries
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References
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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.
Rathmell 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.
Ibrahim 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.
Hassett 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.
Nakai 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.
McCartney 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.
Kunopart 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.
Other Identifiers
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Si 331/2017
Identifier Type: -
Identifier Source: org_study_id
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