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

Arthroplasty, Replacement, Knee Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04206046
• Other study ID #: 001
• Status: Active, not recruiting
• Phase: N/A
• Start date: June 1, 2017
• Est. completion date: December 30, 2023

Study information

• Verified date: October 2022
• Source: Sciberras, Stephen M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 200
• Est. completion date: December 30, 2023
• Est. primary completion date: June 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Spinal anaesthesia
Patients will receive a spinal anaesthetic
• General anaesthesia
patients will receive a general anaesthetic and a femoral nerve block

Locations

Country	Name	City	State
Malta	Mater Dei Hospital	Imsida

Sponsors (1)

Lead Sponsor	Collaborator
Sciberras, Stephen M.D.

Country where clinical trial is conducted

Malta, 

Outcome

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