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

Primary Purpose

Arthroplasty, Replacement, Knee, Chronic Pain Post-Proceduraal

Status

Active

Phase

Not Applicable

Locations

Malta

Study Type

Interventional

Intervention

Spinal anaesthesia

General anaesthesia

About this trial

This is an interventional prevention trial for Arthroplasty, Replacement, Knee focused on measuring arthroplasty, knee, chronic pain

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mater Dei Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

General Anaesthesia

Spinal Anaesthesia

Arm Description

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

Patients will receive a spinal anaesthetic

Outcomes

Primary Outcome Measures

Pain Numerical Rating Scale on physiotherapy

Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)

WOMAC Score at 3 and at 6 months

WOMAC score, ranging from 0 to 94

WOMAC Pain Score at 3 and at 6 months

WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)

Secondary Outcome Measures

Morphine consumption

Morphine use postop

Pain Numerical Rating Scale after 6 months

Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)

Incidence of Chronic Post-surgical Pain

WOMAC pain score greater than 5 at 6 months (out of total of 20)

Change in WOMAC Score at 3 and at 6 months

change in WOMAC score, ranging from 0 to 94

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)

Full Information

NCT ID

NCT04206046

First Posted

December 12, 2019

Last Updated

October 25, 2022

Sponsor

Sciberras, Stephen M.D.

1. Study Identification

Unique Protocol Identification Number

NCT04206046

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2022

Overall Recruitment Status

Active, not recruiting

Study Start Date

June 1, 2017 (Actual)

Primary Completion Date

June 1, 2022 (Actual)

Study Completion Date

December 30, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Sciberras, Stephen M.D.

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Arthroplasty, Replacement, Knee, Chronic Pain Post-Proceduraal

Keywords

arthroplasty, knee, chronic pain

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

InvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

General Anaesthesia

Arm Type

Active Comparator

Arm Description

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

Arm Title

Spinal Anaesthesia

Arm Type

Active Comparator

Arm Description

Patients will receive a spinal anaesthetic

Intervention Type

Procedure

Intervention Name(s)

Spinal anaesthesia

Intervention Description

Patients will receive a spinal anaesthetic

Intervention Type

Procedure

Intervention Name(s)

General anaesthesia

Intervention Description

patients will receive a general anaesthetic and a femoral nerve block

Primary Outcome Measure Information:

Title

Pain Numerical Rating Scale on physiotherapy

Description

Pain Numerical Rating Scale, from 0 (no pain) to 10 (severe pain)

Time Frame

24 hours

Title

WOMAC Score at 3 and at 6 months

Description

WOMAC score, ranging from 0 to 94

Time Frame

6 months

Title

WOMAC Pain Score at 3 and at 6 months

Description

WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)

Time Frame

6 months

Secondary Outcome Measure Information:

Title

Morphine consumption

Description

Morphine use postop

Time Frame

24 hours

Title

Pain Numerical Rating Scale after 6 months

Description

Pain Numerical Rating Scale at rest, from 0 (no pain) to 10 (severe pain)

Time Frame

6 months

Title

Incidence of Chronic Post-surgical Pain

Description

WOMAC pain score greater than 5 at 6 months (out of total of 20)

Time Frame

6 months

Title

Change in WOMAC Score at 3 and at 6 months

Description

change in WOMAC score, ranging from 0 to 94

Time Frame

6 months

Title

Change in WOMAC Pain Score at 3 and at 6 months

Description

change in WOMAC Pain score, ranging from 0 (no pain) to 20 (severe pain on numerous activities)

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Facility Information:

Facility Name

Mater Dei Hospital

City

Imsida

ZIP/Postal Code

MSD2090

Country

Malta

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

35350864

Citation

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.

Results Reference

derived

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

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