search
Back to results

Intrathecal Morphine for Unilateral Total Knee Arthroplasty

Primary Purpose

Primary Osteoarthritis of Knee Nos

Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
50 ug IT morphine
100 ug IT morphine
No IT morphine
Morphine
Bupivacaine
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Primary Osteoarthritis of Knee Nos focused on measuring Intrathecal morphine, total knee arthroplasty

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

No IT morphine

50 ug IT morphine

100 ug IT morphine

Arm Description

Spinal block with 0.5% isobaric with no intrathecal morphine

Spinal block with 0.5% isobaric with 50 ug intrathecal morphine

Spinal block with 0.5% isobaric with 100 ug intrathecal morphine

Outcomes

Primary Outcome Measures

Numerical rating scale
Numerical rating scale 0-10

Secondary Outcome Measures

Morphine requirement
Systemic morphine requirement
Nausea vomiting
Incidence and severity of nausea and vomiting
Pruritus
Incidence and severity of pruritus

Full Information

First Posted
July 26, 2017
Last Updated
May 21, 2021
Sponsor
Mahidol University
search

1. Study Identification

Unique Protocol Identification Number
NCT03232957
Brief Title
Intrathecal Morphine for Unilateral Total Knee Arthroplasty
Official Title
Efficacy and Side Effects of Intrathecal Morphine in Multimodal Analgesia for Unilateral Total Knee Arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
August 1, 2017 (Actual)
Primary Completion Date
February 1, 2019 (Actual)
Study Completion Date
July 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mahidol University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Primary Osteoarthritis of Knee Nos
Keywords
Intrathecal morphine, total knee arthroplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Masking Description
In the anesthetic record, 0.5% isobaric bupivacaine with study drug is recorded.
Allocation
Randomized
Enrollment
131 (Actual)

8. Arms, Groups, and Interventions

Arm Title
No IT morphine
Arm Type
Experimental
Arm Description
Spinal block with 0.5% isobaric with no intrathecal morphine
Arm Title
50 ug IT morphine
Arm Type
Experimental
Arm Description
Spinal block with 0.5% isobaric with 50 ug intrathecal morphine
Arm Title
100 ug IT morphine
Arm Type
Experimental
Arm Description
Spinal block with 0.5% isobaric with 100 ug intrathecal morphine
Intervention Type
Procedure
Intervention Name(s)
50 ug IT morphine
Intervention Description
Spinal block with bupivacaine and intrathecal morphine 50 ug
Intervention Type
Procedure
Intervention Name(s)
100 ug IT morphine
Intervention Description
Spinal block with bupivacaine and intrathecal morphine 100 ug
Intervention Type
Procedure
Intervention Name(s)
No IT morphine
Intervention Description
Spinal block with bupivacaine and intrathecal morphine 0 ug
Intervention Type
Drug
Intervention Name(s)
Morphine
Intervention Description
intrathecal morphine
Intervention Type
Drug
Intervention Name(s)
Bupivacaine
Intervention Description
0.5 isobaric bupivacaine
Primary Outcome Measure Information:
Title
Numerical rating scale
Description
Numerical rating scale 0-10
Time Frame
Within 48 hours
Secondary Outcome Measure Information:
Title
Morphine requirement
Description
Systemic morphine requirement
Time Frame
Within 48 hours
Title
Nausea vomiting
Description
Incidence and severity of nausea and vomiting
Time Frame
Within 48 hours
Title
Pruritus
Description
Incidence and severity of pruritus
Time Frame
Within 48 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Suwimon Tangwiwat, MD
Organizational Affiliation
Faculty of Medicine Siriraj Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkok Noi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
25550024
Citation
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.
Results Reference
background
PubMed Identifier
14570664
Citation
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.
Results Reference
background
PubMed Identifier
24025284
Citation
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.
Results Reference
background
PubMed Identifier
18816386
Citation
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.
Results Reference
background
PubMed Identifier
24403757
Citation
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.
Results Reference
background
PubMed Identifier
24399578
Citation
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.
Results Reference
background
PubMed Identifier
24765899
Citation
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.
Results Reference
background

Learn more about this trial

Intrathecal Morphine for Unilateral Total Knee Arthroplasty

We'll reach out to this number within 24 hrs