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Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

Primary Purpose

Pain, Postoperative

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Bupivacaine Hydrochloride, Spinal
Morphine hydrochloride, Spinal
Placebo - Concentrate
Sponsored by
South Carelia Central Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Pain, Postoperative

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • elective primary total knee arthroplasty
  • ASA I-III
  • written consent

Exclusion Criteria:

  • rearthroplasty
  • ASA IV-V
  • inadequate spoken finnish for reliable pain assessment
  • Dementia or otherwise impaired cognition
  • contraindication for any medication or substance used in survey protocol
  • weight <50kg or BMI ≥35 kg/m2
  • preoperative SpO2 less than 93%
  • clinical suspicion that subject can not use PCA adequately
  • history of substance abuse or current excessive use of alcohol
  • preoperative use of either pregabalin, gabapentin or strong opiates

Sites / Locations

  • South Carelia Central HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Intrathecal morphine and bupivacaine

Placebo

Arm Description

0,2mg intrathecal morphine and 12,5mg bupivacaine administered

12,5mg bupivacaine and NaCl 0,9% to match the same volume administered

Outcomes

Primary Outcome Measures

intravenous oxycodone consumption
Cumulative postoperative consumption

Secondary Outcome Measures

Adverse effects of 0,2mg intrathecal morphine
Possible nausea, vomiting, itching and respiratory depression
Mobilization time
Assessing the time to ambulation
Patient satisfaction
Telephone interview 28 days after surgery

Full Information

First Posted
December 10, 2017
Last Updated
February 14, 2018
Sponsor
South Carelia Central Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03434951
Brief Title
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty
Official Title
Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty, a Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2018
Overall Recruitment Status
Unknown status
Study Start Date
November 6, 2017 (Actual)
Primary Completion Date
September 1, 2019 (Anticipated)
Study Completion Date
September 1, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
South Carelia Central Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
Double-blinded randomized control study investigating intrathecal morphine as an additive to spinal anesthesia in patients undergoing elective total knee arthroplasty. The investigators aim to include a total of 120 patients, randomized to two equal groups. Participants in the intervention group are administered intrathecal 0,2mg morphine and 12,5mg bupivacaine for spinal anaesthesia. Participants in the placebo group are administered 12.5mg bupivacaine and saline to match the volume of intervention goup. Primary end points are opioid consumption and possible adverse effects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
120 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Intrathecal morphine and bupivacaine
Arm Type
Experimental
Arm Description
0,2mg intrathecal morphine and 12,5mg bupivacaine administered
Arm Title
Placebo
Arm Type
Active Comparator
Arm Description
12,5mg bupivacaine and NaCl 0,9% to match the same volume administered
Intervention Type
Drug
Intervention Name(s)
Bupivacaine Hydrochloride, Spinal
Intervention Description
Intrathecally administered 12,5mg bupivacaine for spinal anaesthesia
Intervention Type
Drug
Intervention Name(s)
Morphine hydrochloride, Spinal
Intervention Description
Intrathecally administered morphine 0,2mg (2mg/ml, 0,1ml)
Intervention Type
Drug
Intervention Name(s)
Placebo - Concentrate
Other Intervention Name(s)
physiologic saline solution
Intervention Description
Intrathecally administered saline solution 0,9% 0,1ml to match morphine volume
Primary Outcome Measure Information:
Title
intravenous oxycodone consumption
Description
Cumulative postoperative consumption
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Adverse effects of 0,2mg intrathecal morphine
Description
Possible nausea, vomiting, itching and respiratory depression
Time Frame
48 hours
Title
Mobilization time
Description
Assessing the time to ambulation
Time Frame
48 hours
Title
Patient satisfaction
Description
Telephone interview 28 days after surgery
Time Frame
28 days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: elective primary total knee arthroplasty ASA I-III written consent Exclusion Criteria: rearthroplasty ASA IV-V inadequate spoken finnish for reliable pain assessment Dementia or otherwise impaired cognition contraindication for any medication or substance used in survey protocol weight <50kg or BMI ≥35 kg/m2 preoperative SpO2 less than 93% clinical suspicion that subject can not use PCA adequately history of substance abuse or current excessive use of alcohol preoperative use of either pregabalin, gabapentin or strong opiates
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Susanna Niinimäki, BSc, SRN /Anesthesia
Phone
+358406511388
Email
susanna.niinimaki@eksote.fi
First Name & Middle Initial & Last Name or Official Title & Degree
Seppo Mustola, MD, PhD
Phone
+358447915832
Email
seppo.mustola@eksote.fi
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Seppo Mustola, MD, PhD
Organizational Affiliation
South Carelia Central Hospital
Official's Role
Study Director
Facility Information:
Facility Name
South Carelia Central Hospital
City
Lappeenranta
ZIP/Postal Code
53130
Country
Finland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Susanna Niinimäki, BSc, SRN /Anesthesia
Phone
+358406511388
Email
Susanna.niinimaki@eksote.fi
First Name & Middle Initial & Last Name & Degree
MD, PhD

12. IPD Sharing Statement

Plan to Share IPD
No

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Intrathecal Morphine and Local Infiltration Analgesia in Total Knee Arthroplasty

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