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

NCT ID: NCT04206046

Last Updated: 2022-10-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

200 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-06-01

Study Completion Date

2023-12-30

Brief Summary

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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

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Conditions

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Arthroplasty, Replacement, Knee Chronic Pain Post-Proceduraal

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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General Anaesthesia

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

Group Type ACTIVE_COMPARATOR

General anaesthesia

Intervention Type PROCEDURE

patients will receive a general anaesthetic and a femoral nerve block

Spinal Anaesthesia

Patients will receive a spinal anaesthetic

Group Type ACTIVE_COMPARATOR

Spinal anaesthesia

Intervention Type PROCEDURE

Patients will receive a spinal anaesthetic

Interventions

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Spinal anaesthesia

Patients will receive a spinal anaesthetic

Intervention Type PROCEDURE

General anaesthesia

patients will receive a general anaesthetic and a femoral nerve block

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Sciberras, Stephen M.D.

INDIV

Sponsor Role lead

Responsible Party

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Stephen Sciberras

Lead investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Mater Dei Hospital

Msida, , Malta

Site Status

Countries

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Malta

References

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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.

Reference Type DERIVED
PMID: 35350864 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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001

Identifier Type: -

Identifier Source: org_study_id

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