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

Not Applicable

Active, not recruiting

• Conditions: Arthroplasty, Replacement, Knee; Chronic Pain Post-Proceduraal
• Interventions: Procedure: General anaesthesia; Procedure: Spinal anaesthesia

• Registration Number: NCT04206046
• Lead Sponsor: Sciberras, Stephen M.D.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2017-06-01
• Study First Submitted: 2019-12-12
• Study First Submitted QC: 2019-12-17
• Study First Posted: 2019-12-20
• Primary Completion: 2022-06-01
• Status Verified: 2022-10
• Last Update Submitted: 2022-10-25
• Last Update Posted: 2022-10-26
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 200

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
General Anaesthesia	General anaesthesia	Patients will receive a general anaesthetic, together with a femoral nerve block.
Spinal Anaesthesia	Spinal anaesthesia	Patients will receive a spinal anaesthetic

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

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

Trial Locations

Locations (1)

Mater Dei Hospital; 🇲🇹 Imsida, Malta