Arthroplasty, Replacement, KneeNCT04206046
The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
A study testing Spinal anaesthesia and General anaesthesia in people with Arthroplasty, Replacement, Knee and Chronic Pain Post-Proceduraal, run by Sciberras, Stephen M.D. at 1 site in Malta.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Arthroplasty, Replacement, Knee, Chronic Pain Post-Proceduraal
- What is being tested?
- Spinal anaesthesia and General anaesthesia
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteMalta
- Study dates
- 1 Jun 2017to 30 Dec 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- patients able to undergo a total knee arthroplasty
Who cannot join
- age more than 75 years
- known case of chronic pain syndromes
- arthroplasty not due to osteoarthritis
- sensitivity to any drugs used in protocol
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Being tested
- Spinal anaesthesia, General anaesthesia
- Keywords
- arthroplasty, knee, chronic pain
- Medical subject headings
- Chronic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Spinal anaesthesiaProcedure or surgery
Patients will receive a spinal anaesthetic
General anaesthesiaProcedure or surgery
patients will receive a general anaesthetic and a femoral nerve block
| Study group | Role | What they receive |
|---|---|---|
| General Anaesthesia | Active comparator | Patients will receive a general anaesthetic, together with a femoral nerve block. Receives: Procedure: General anaesthesia |
| Spinal Anaesthesia | Active comparator | Patients will receive a spinal anaesthetic Receives: Procedure: Spinal anaesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Numerical Rating Scale on physiotherapy
Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
Measured: 24 hours
WOMAC Score at 3 and at 6 months
WOMAC score, ranging from 0 to 94
Measured: 6 months
WOMAC Pain Score at 3 and at 6 months
WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
Measured: 6 months
Secondary outcomes (5)
Morphine consumption
Morphine use postop
Measured: 24 hours
Pain Numerical Rating Scale after 6 months
Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)
Measured: 6 months
Incidence of Chronic Post-surgical Pain
WOMAC pain score greater than 5 at 6 months (out of total of 20)
Measured: 6 months
Change in WOMAC Score at 3 and at 6 months
change in WOMAC score, ranging from 0 to 94
Measured: 6 months
Change in WOMAC Pain Score at 3 and at 6 months
change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Dec 2019
- Study start1 Jun 2017
- Primary completion1 Jun 2022
- Study completion30 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arthroplasty, Replacement, KneeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sciberras, Stephen M.D.
- Responsible party
- Principal investigator, Stephen Sciberras, Sciberras, Stephen M.D.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04206046
- Sponsor's protocol ID
- 001
- Status last verified
- Oct 2022
- First submitted
- 12 Dec 2019
- Last updated
- 26 Oct 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sciberras SC, Vella AP, Vella B, Spiteri J, Mizzi C, Borg-Xuereb K, LaFerla G, Grech G, Sammut F. A randomized, controlled trial on the effect of anesthesia on chronic pain after total knee arthroplasty. Pain Manag. 2022 Sep;12(6):711-723. doi: 10.2217/pmt-2021-0081. Epub 2022 Mar 30.
PubMed 35350864
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
- ClinicalTrials.gov ID
- NCT04206046
- Acronym / sponsor ID
- 001
- Keywords
- arthroplasty, knee, chronic pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Sciberras, Stephen M.D.
- Study start
- 1 Jun 2017 (actual)
- Primary completion
- 1 Jun 2022 (actual)
- Study completion
- 30 Dec 2023 (estimated)
- First posted
- 20 Dec 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| General Anaesthesia | Active comparator | Procedure: General anaesthesiaPatients will receive a general anaesthetic, together with a femoral nerve block. |
| Spinal Anaesthesia | Active comparator | Procedure: Spinal anaesthesiaPatients will receive a spinal anaesthetic |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- patients able to undergo a total knee arthroplasty
Key exclusion criteria (4 listed)
- age more than 75 years
- known case of chronic pain syndromes
- arthroplasty not due to osteoarthritis
- sensitivity to any drugs used in protocol
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Spinal anaesthesiaPatients will receive a spinal anaesthetic | Procedure or surgery | Spinal Anaesthesia |
| General anaesthesiapatients will receive a general anaesthetic and a femoral nerve block | Procedure or surgery | General Anaesthesia |
Primary outcome
Pain Numerical Rating Scale on physiotherapy
Time frame: 24 hours
Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
WOMAC Score at 3 and at 6 months
Time frame: 6 months
WOMAC score, ranging from 0 to 94
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)
5 secondary outcomes
Morphine consumption
Time frame: 24 hours
Pain Numerical Rating Scale after 6 months
Time frame: 6 months
Incidence of Chronic Post-surgical Pain
Time frame: 6 months
Change in WOMAC Score at 3 and at 6 months
Time frame: 6 months
Change in WOMAC Pain Score at 3 and at 6 months
Time frame: 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2022.
- Derived from this study: PubMed 35350864Sciberras SC, Vella AP, Vella B, Spiteri J, Mizzi C, Borg-Xuereb K, LaFerla G, Grech G, Sammut F. A randomized, controlled trial on the effect of anesthesia on chronic pain after total knee arthroplasty. Pain Manag. 2022 Sep;12(6):711-723. doi: 10.2217/pmt-2021-0081. Epub 2022 Mar 30.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Spinal anaesthesia and General anaesthesia in people with Arthroplasty, Replacement, Knee and Chronic Pain Post-Proceduraal, run by Sciberras, Stephen M.D. at 1 site in Malta.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Malta. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Numerical Rating Scale on physiotherapy (time frame: 24 hours). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04206046, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2022.