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Status unknownNCT04206046Updated Oct 26, 2022

The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty

An interventional study of Spinal anaesthesia and General anaesthesia in Arthroplasty, Replacement, Knee and Chronic Pain Post-Proceduraal, sponsored by Sciberras, Stephen M.D.. Status unknown at 1 site in Malta. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-26.

Sponsored by Sciberras, Stephen M.D. · Not applicable, Interventional, and Prevention

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Active, not recruiting — may be out of date.

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jun 2017, registered Dec 2019).
Phase
Not applicable
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Arthroplasty, Replacement, Knee
  • Chronic Pain Post-Proceduraal

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Keywords

  • arthroplasty, knee
  • chronic pain
03

In context

Chronic Pain

3,227 studies on the registry are indexed under Chronic Pain; 729 are open to participants now.

This study's planned enrollment of 200 is above the median of 60 across 2,388 interventional studies indexed under Chronic Pain.

Browse Chronic Pain studies →

Lead sponsor

Sciberras, Stephen M.D. is the lead sponsor of 4 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • patients able to undergo a total knee arthroplasty

Exclusion criteria

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
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Investigator, Outcomes assessor)
Enrollment
200 participants (estimated)

Study arms

  • Active comparator
    General Anaesthesia

    Patients will receive a general anaesthetic, together with a femoral nerve block.

    Procedure: General anaesthesia

  • Active comparator
    Spinal Anaesthesia

    Patients will receive a spinal anaesthetic

    Procedure: Spinal anaesthesia

Interventions

  • ProcedureSpinal anaesthesia

    Patients will receive a spinal anaesthetic

  • ProcedureGeneral anaesthesia

    patients will receive a general anaesthetic and a femoral nerve block

06

What researchers measure

Primary outcomes

  1. Pain Numerical Rating Scale on physiotherapy

    Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)

    Time frame: 24 hours

  2. WOMAC Score at 3 and at 6 months

    WOMAC score, ranging from 0 to 94

    Time frame: 6 months

  3. WOMAC Pain Score at 3 and at 6 months

    WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)

    Time frame: 6 months

Secondary outcomes

  1. Morphine consumption

    Morphine use postop

    Time frame: 24 hours

  2. Pain Numerical Rating Scale after 6 months

    Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)

    Time frame: 6 months

  3. Incidence of Chronic Post-surgical Pain

    WOMAC pain score greater than 5 at 6 months (out of total of 20)

    Time frame: 6 months

  4. Change in WOMAC Score at 3 and at 6 months

    change in WOMAC score, ranging from 0 to 94

    Time frame: 6 months

  5. 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)

    Time frame: 6 months

07

Study locations

1 site
  • Mater Dei Hospital
    Imsida, MSD2090, Malta
08

References and documents

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 documents

PDFs hosted by the registry, ClinicalTrials.gov.

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Ran from Jun 2017 to primary completion in Jun 2022, 60 months.

Of 1,295 non-industry interventional studies with no phase under Chronic Pain, half reached primary completion within 20 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 39. This study's 60 months is above that.

Counting every sponsor, half of 1,378 studies reached it within 20 months; a quarter within 9 and three quarters within 38.

How these figures are worked out, and which studies are left out of them.

Registered
Dec 12, 2019
First posted
Dec 20, 2019
StartActual
Jun 1, 2017
Primary completionActual
Jun 1, 2022
CompletionEst.
Dec 30, 2023
Last update
Oct 26, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 26, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04206046
Lead sponsor
Sciberras, Stephen M.D.
Responsible party
Stephen Sciberras (Lead investigator, Sciberras, Stephen M.D.) — Principal investigator
First posted
Dec 20, 2019
Start date
Jun 1, 2017
Primary completion
Jun 1, 2022
Completion
Dec 30, 2023 (estimated)
Last update
Oct 26, 2022

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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Discussion

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