Intrathecal Morphine for Unilateral Total Knee Arthroplasty

NCT ID: NCT03232957

Last Updated: 2021-05-24

Study Results

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

131 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-08-01

Study Completion Date

2019-07-31

Brief Summary

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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

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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

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Primary Osteoarthritis of Knee Nos

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors
In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.

Study Groups

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No IT morphine

Spinal block with 0.5% isobaric with no intrathecal morphine

Group Type EXPERIMENTAL

No IT morphine

Intervention Type PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 0 ug

Morphine

Intervention Type DRUG

intrathecal morphine

Bupivacaine

Intervention Type DRUG

0.5 isobaric bupivacaine

50 ug IT morphine

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

Group Type EXPERIMENTAL

50 ug IT morphine

Intervention Type PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 50 ug

Morphine

Intervention Type DRUG

intrathecal morphine

Bupivacaine

Intervention Type DRUG

0.5 isobaric bupivacaine

100 ug IT morphine

Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Group Type EXPERIMENTAL

100 ug IT morphine

Intervention Type PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 100 ug

Morphine

Intervention Type DRUG

intrathecal morphine

Bupivacaine

Intervention Type DRUG

0.5 isobaric bupivacaine

Interventions

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50 ug IT morphine

Spinal block with bupivacaine and intrathecal morphine 50 ug

Intervention Type PROCEDURE

100 ug IT morphine

Spinal block with bupivacaine and intrathecal morphine 100 ug

Intervention Type PROCEDURE

No IT morphine

Spinal block with bupivacaine and intrathecal morphine 0 ug

Intervention Type PROCEDURE

Morphine

intrathecal morphine

Intervention Type DRUG

Bupivacaine

0.5 isobaric bupivacaine

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

* Aged more than 18 years old undergoing unilateral total knee arthroplasty
* American Society of Anesthesiologists physical status classification 1-3

Exclusion Criteria

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mahidol University

OTHER

Sponsor Role lead

Responsible Party

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Suwimon Tangwiwat

Assistant professor, Department of Anesthesiology

Responsibility Role PRINCIPAL_INVESTIGATOR

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

Site Status

Countries

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Thailand

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.

Reference Type BACKGROUND
PMID: 25550024 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 14570664 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24025284 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18816386 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24403757 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24399578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 24765899 (View on PubMed)

Other Identifiers

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Si 331/2017

Identifier Type: -

Identifier Source: org_study_id

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