Intrathecal Morphine for Unilateral Total Knee Arthroplasty

NCT03232957 | Completed

• 1 other identifier: Si 331/2017
• Study Type: interventional
• Target: 131
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Primary Osteoarthritis of Knee Nos

Keywords

Intrathecal morphine, total knee arthroplasty

Outcome Measures

Primary Outcomes (1)

• Numerical rating scale

  Numerical rating scale 0-10

  Within 48 hours

Secondary Outcomes (3)

• Morphine requirement

  Within 48 hours

• Nausea vomiting

  Within 48 hours

• Pruritus

  Within 48 hours

Study Arms (3)

No IT morphine

EXPERIMENTAL

Spinal block with 0.5% isobaric with no intrathecal morphine

Procedure: No IT morphine; Drug: Morphine; Drug: Bupivacaine

50 ug IT morphine

EXPERIMENTAL

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

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

Procedure: 100 ug IT morphine; Drug: Morphine; Drug: Bupivacaine

Interventions

50 ug IT morphine PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 50 ug

50 ug IT morphine

100 ug IT morphine PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 100 ug

100 ug IT morphine

No IT morphine PROCEDURE

Spinal block with bupivacaine and intrathecal morphine 0 ug

No IT morphine

Morphine DRUG

intrathecal morphine

100 ug IT morphine; 50 ug IT morphine; No IT morphine

Bupivacaine DRUG

0.5 isobaric bupivacaine

100 ug IT morphine; 50 ug IT morphine; No IT morphine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mahidol University: lead

Study Sites (1)

Faculty of Medicine Siriraj Hospital, Mahidol University

Bangkok Noi, Bangkok, 10700, Thailand

Location

Related Publications (7)

• 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.

  PMID: 25550024 BACKGROUND

• 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.

  PMID: 14570664 BACKGROUND

• 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.

  PMID: 24025284 BACKGROUND

• 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.

  PMID: 18816386 BACKGROUND

• 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.

  PMID: 24403757 BACKGROUND

• 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.

  PMID: 24399578 BACKGROUND

• 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.

  PMID: 24765899 BACKGROUND

MeSH Terms

Interventions

Morphine; Bupivacaine

Intervention Hierarchy (Ancestors)

Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• Suwimon Tangwiwat, MD

  Siriraj Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant professor, Department of Anesthesiology

Study Record Dates

• First Submitted: July 26, 2017
• First Posted: July 28, 2017
• Study Start: August 1, 2017
• Primary Completion: February 1, 2019
• Study Completion: July 31, 2019
• Last Updated: May 24, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

TH (1)