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Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

Primary Purpose

Knee Joint Osteoarthrosis, Hyperalgesia, Severe Movement Related Pain

Status
Completed
Phase
Phase 2
Locations
Denmark
Study Type
Interventional
Intervention
Methylprednisoloneacetate
Lidocaine
sodium chloride
Sponsored by
Rigshospitalet, Denmark
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Knee Joint Osteoarthrosis

Eligibility Criteria

50 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Age 50 -80
  • Osteoarthrosis
  • Scheduled for primary unilateral TKA
  • Preoperative pain report with NRS > 5 upon walking
  • Signs of sensitisation in knee

Exclusion Criteria:

  • Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment
  • Deficient written or spoken danish
  • Impairment from psychological or neurological disease
  • Local og systemic infection
  • Immunodeficiency
  • Treatment with corticosteroid within 30 days of inclusion
  • Insulin treated diabetes mellitus
  • Anticoagulant therapy
  • ASA (American Society of Anaesthesia) class > 3
  • General anaesthesia
  • Alchohol use > 21 units / week
  • Pregnancy

Sites / Locations

  • Gentofte Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Methylprednisoloneacetate

Sodium chloride

Arm Description

Administration of: 1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.

Administration of: 5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.

Outcomes

Primary Outcome Measures

Pain
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery

Secondary Outcome Measures

Pain
Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following
Pain
Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day
Pain
Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day
Sensitisation
Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.
Inflammation
Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.
Inflammation
Measurement of interleukin-6 level in knee joint fluid on the day of surgery.

Full Information

First Posted
September 29, 2014
Last Updated
June 3, 2016
Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT02253966
Brief Title
Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
March 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Rigshospitalet, Denmark
Collaborators
Lundbeck Foundation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
Despite improvements in analgesic treatment following total knee arthroplasty (TKA) for osteoarthrosis, a substantial part of patients still have severe acute pain after surgery. It has been suggested that preoperative degree of intraarticular inflammation is associated to postoperative degree of pain and level of function. Furthermore it is known, that patients with preoperative inflammation have hyperalgesia and severe movement related pain. The aim of this study is to investigate the effect of a preoperative intraarticular injection of Methylprednisoloneacetate in reducing acute postoperative pain after total knee arthroplasty in patients with signs of severe pre-operative inflammation and pain.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Knee Joint Osteoarthrosis, Hyperalgesia, Severe Movement Related Pain

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Methylprednisoloneacetate
Arm Type
Active Comparator
Arm Description
Administration of: 1 ml methylprednisoloneacetate 40 mg/ml 5 ml lidocaine 20 mg/ml 4 ml sodium chloride 9 mg/ml as a single intraarticular injection 7 days prior to surgery.
Arm Title
Sodium chloride
Arm Type
Placebo Comparator
Arm Description
Administration of: 5 ml lidocaine 20 mg/ml 5 ml sodium chloride 9 mg/ml as a singe intraarticular injection 7 days prior to surgery.
Intervention Type
Drug
Intervention Name(s)
Methylprednisoloneacetate
Other Intervention Name(s)
Depo-Medrol
Intervention Type
Drug
Intervention Name(s)
Lidocaine
Intervention Type
Other
Intervention Name(s)
sodium chloride
Other Intervention Name(s)
saline
Primary Outcome Measure Information:
Title
Pain
Description
Pain intensity on a numeric rang scale (NRS) from 0 to 10 upon ambulation 24 hours following surgery
Time Frame
24 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain
Description
Pain intensity on a NRS from 0 to 10 upon ambulation 48 hours following
Time Frame
48 hours postoperatively
Title
Pain
Description
Diary-reported pain intensity on a NRS from 0 to 10 when walking. Once daily from first to fourteenth postoperative day
Time Frame
From day 1 to day 14
Title
Pain
Description
Diary-reported pain intensity on a NRS from 0 to 10 upon rest. Once daily from first to fourteenth postoperative day
Time Frame
From day 1 to day 14
Title
Sensitisation
Description
Quantitative sensory testing (temporal summation / pressure algometry) on the day of surgery and on the second postoperative day.
Time Frame
On day 0 and day 2
Title
Inflammation
Description
Measurement of C-reactive protein in blood sample on the day of surgery and on the second postoperative day.
Time Frame
On day 0 and day 2
Title
Inflammation
Description
Measurement of interleukin-6 level in knee joint fluid on the day of surgery.
Time Frame
On day 0

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Age 50 -80 Osteoarthrosis Scheduled for primary unilateral TKA Preoperative pain report with NRS > 5 upon walking Signs of sensitisation in knee Exclusion Criteria: Allergies to methylprednisoloneacetate, lidocaine or standard analgesic treatment Deficient written or spoken danish Impairment from psychological or neurological disease Local og systemic infection Immunodeficiency Treatment with corticosteroid within 30 days of inclusion Insulin treated diabetes mellitus Anticoagulant therapy ASA (American Society of Anaesthesia) class > 3 General anaesthesia Alchohol use > 21 units / week Pregnancy
Facility Information:
Facility Name
Gentofte Hospital
City
Hellerup
ZIP/Postal Code
2900
Country
Denmark

12. IPD Sharing Statement

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Preoperative Intraarticular Injection of Methylprednisolone in Patients Scheduled for Total Knee-arthroplasty

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