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

October 25, 2022 updated by: Stephen Sciberras, Sciberras, Stephen M.D.

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 Overview

Study Type

Interventional

Enrollment (Anticipated)

200

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Imsida, Malta, MSD2090
        • Mater Dei Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: General Anaesthesia
Patients will receive a general anaesthetic, together with a femoral nerve block.
patients will receive a general anaesthetic and a femoral nerve block
ACTIVE_COMPARATOR: Spinal Anaesthesia
Patients will receive a spinal anaesthetic
Patients will receive a spinal anaesthetic

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

June 1, 2017

Primary Completion (ACTUAL)

June 1, 2022

Study Completion (ANTICIPATED)

December 30, 2023

Study Registration Dates

First Submitted

December 12, 2019

First Submitted That Met QC Criteria

December 17, 2019

First Posted (ACTUAL)

December 20, 2019

Study Record Updates

Last Update Posted (ACTUAL)

October 26, 2022

Last Update Submitted That Met QC Criteria

October 25, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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