- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04206046
The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
October 25, 2022 updated by: Stephen Sciberras, Sciberras, Stephen M.D.
The study aims to assess the effect of spinal anaesthesia against a general anaesthesia with a femoral block, with respect to the incidence of chronic pain following a total knee replacement.
It will also focus on genetic factors and their influence on chronic pain.
Study Overview
Status
Active, not recruiting
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Imsida, Malta, MSD2090
- Mater Dei Hospital
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 75 years (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- patients able to undergo a total knee arthroplasty
Exclusion Criteria:
- age more than 75 years
- known case of chronic pain syndromes
- arthroplasty not due to osteoarthritis
- sensitivity to any drugs used in protocol
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
ACTIVE_COMPARATOR: General Anaesthesia
Patients will receive a general anaesthetic, together with a femoral nerve block.
|
patients will receive a general anaesthetic and a femoral nerve block
|
ACTIVE_COMPARATOR: Spinal Anaesthesia
Patients will receive a spinal anaesthetic
|
Patients will receive a spinal anaesthetic
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pain Numerical Rating Scale on physiotherapy
Time Frame: 24 hours
|
Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
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24 hours
|
WOMAC Score at 3 and at 6 months
Time Frame: 6 months
|
WOMAC score, ranging from 0 to 94
|
6 months
|
WOMAC Pain Score at 3 and at 6 months
Time Frame: 6 months
|
WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
|
6 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Morphine consumption
Time Frame: 24 hours
|
Morphine use postop
|
24 hours
|
Pain Numerical Rating Scale after 6 months
Time Frame: 6 months
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Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)
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6 months
|
Incidence of Chronic Post-surgical Pain
Time Frame: 6 months
|
WOMAC pain score greater than 5 at 6 months (out of total of 20)
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6 months
|
Change in WOMAC Score at 3 and at 6 months
Time Frame: 6 months
|
change in WOMAC score, ranging from 0 to 94
|
6 months
|
Change in WOMAC Pain Score at 3 and at 6 months
Time Frame: 6 months
|
change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
|
6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (ACTUAL)
June 1, 2017
Primary Completion (ACTUAL)
June 1, 2022
Study Completion (ANTICIPATED)
December 30, 2023
Study Registration Dates
First Submitted
December 12, 2019
First Submitted That Met QC Criteria
December 17, 2019
First Posted (ACTUAL)
December 20, 2019
Study Record Updates
Last Update Posted (ACTUAL)
October 26, 2022
Last Update Submitted That Met QC Criteria
October 25, 2022
Last Verified
October 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 001 (NavyGHB)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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