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

• Sponsor: Sciberras, Stephen M.D. (Other)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04206046
• Collaborator: (none)
• Enrollment: 200
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 78.9
• Patients Per Site Per Month: 2.5

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Arthroplasty, Replacement, Knee; Chronic Pain Post-Proceduraal	Procedure: Spinal anaesthesia; Procedure: General anaesthesia	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 200 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Investigator, Outcomes Assessor)
• Primary Purpose: Prevention
• Official Title: The Effect of Regional Anaesthesia and Genetic Factors in the Development of Chronic Pain Following Total Knee Arthroplasty
• Actual Study Start Date: Jun 1, 2017
• Anticipated Primary Completion Date: Jun 1, 2022
• Anticipated Study Completion Date: Dec 30, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: General Anaesthesia Patients will receive a general anaesthetic, together with a femoral nerve block.	Procedure: General anaesthesia; patients will receive a general anaesthetic and a femoral nerve block
Active Comparator: Spinal Anaesthesia Patients will receive a spinal anaesthetic	Procedure: Spinal anaesthesia; Patients will receive a spinal anaesthetic

Outcome Measures

Primary Outcome Measures

1. Pain Numerical Rating Scale on physiotherapy [24 hours]

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

2. WOMAC Score at 3 and at 6 months [6 months]

   WOMAC score, ranging from 0 to 94

3. 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

1. Morphine consumption [24 hours]

   Morphine use postop

2. Pain Numerical Rating Scale after 6 months [6 months]

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

3. Incidence of Chronic Post-surgical Pain [6 months]

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

4. Change in WOMAC Score at 3 and at 6 months [6 months]

   change in WOMAC score, ranging from 0 to 94

5. 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)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Mater Dei Hospital	Imsida		Malta	MSD2090

Sponsors and Collaborators

• Sciberras, Stephen M.D.

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Dec 18, 2018

More Information

Publications

None provided.

• Responsible Party: Stephen Sciberras, Lead investigator, Sciberras, Stephen M.D.
• ClinicalTrials.gov Identifier: NCT04206046
• Other Study ID Numbers: 001
• First Posted: Dec 20, 2019
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Stephen Sciberras, Lead investigator, Sciberras, Stephen M.D.: arthroplasty, knee; chronic pain
• Additional relevant MeSH terms: Chronic Pain; Anesthetics

Study Results

No Results Posted as of Sep 13, 2021