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

Status

UNKNOWN

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04206046

Enrollment

200

Registered

2019-12-20

Start date

2017-06-01

Completion date

2023-12-30

Last updated

2022-10-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthroplasty, Replacement, Knee, Chronic Pain Post-Proceduraal

Keywords

arthroplasty, knee, chronic pain

Brief 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.

Interventions

PROCEDURESpinal anaesthesia

Patients will receive a spinal anaesthetic

PROCEDUREGeneral anaesthesia

patients will receive a general anaesthetic and a femoral nerve block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

DOUBLE (Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Pain Numerical Rating Scale on physiotherapy	24 hours	Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)
WOMAC Score at 3 and at 6 months	6 months	WOMAC score, ranging from 0 to 94
WOMAC Pain Score at 3 and at 6 months	6 months	WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)

Secondary

Measure	Time frame	Description
Change in WOMAC Score at 3 and at 6 months	6 months	change in WOMAC score, ranging from 0 to 94
Morphine consumption	24 hours	Morphine use postop
Change in WOMAC Pain Score at 3 and at 6 months	6 months	change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)
Pain Numerical Rating Scale after 6 months	6 months	Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)
Incidence of Chronic Post-surgical Pain	6 months	WOMAC pain score greater than 5 at 6 months (out of total of 20)

Countries

Malta

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026