Ignite Creation Date:
2024-05-06 @ 6:09 PM
Last Modification Date:
2024-10-26 @ 2:42 PM
Study NCT ID:
NCT05563155
Status:
COMPLETED
Last Update Posted:
2024-06-28
First Post:
2022-09-16
Brief Title:
Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response
Sponsor:
Vejle Hospital
Organization:
Vejle Hospital
Study Overview
Official Title:
Repeat Dose Steroid to Prevent Pain Relapse After Total Knee Arthroplasty in Patients With High Pain Response - A Randomized Double-blind Placebo-controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of the study is to compare the effect of a repeat moderate dose of glucocorticoids postoperatively after preoperative high dose upon postoperative pain after Total Knee Arthroplasty TKA in an High Pain Respondes HPR population to a standard single high dose systemic preoperative administration in an HPR population
As a standard procedure all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale PCS If TKA is decided patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mgkg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA
The repeat-dosing group RDG will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day The control-group CG will receive placebo tablets at 9-11 pm on the first postoperative day
As a standard procedure all patients referred to the outpatient clinic due to suspected degenerative knee disease will be asked to fulfill the Pain Catastrophizing Scale PCS If TKA is decided patients with a PCS score above 20 will be treated with intravenously administered Dexamethasone 1 mgkg as a rounded-up-dose to closest 10 mg according to our guideline for FAST-TRACK TKA
The repeat-dosing group RDG will receive a dose of 24 mg dexamethasone tablets at 9-11 pm on the first postoperative day The control-group CG will receive placebo tablets at 9-11 pm on the first postoperative day
Detailed Description:
Total hip and knee arthroplasty THATKA are frequently performed procedures and are expected to increase in numbers along with the growing elderly population the next decade
Total Knee Arthroplasty TKA is suitable for FAST-TRACK surgery and is often performed as outpatient surgery with no hospital overnight stay
Challenges in FAST-TRACK surgery include postoperative pain nausea and vomiting PONV complications due to rescue-analgesics and surgical complications
Pain is a well-known clinical problem with up to 75 of TKA patients experiencing moderate to severe pain the first day after surgery and 30-40 still experiencing moderate to severe pain 2 weeks after surgery potentially delaying ambulation and recovery within the first weeks
The role of severe acute postoperative pain upon the development of chronic pain is debatable but important
Data from our recently finished study in High Pain Responders HPR defined as patients with a score above 20 on the Pain Catastrophizing Scale PCS receiving preoperative high dose dexamethasone Nielsen et al IN PREPARATION clinicaltrialsgov ID NCT03763734 EudraCT 2018-002635-23 VEK H-18034778 found a persistent moderate to severe pain in 40 of patients at time 48 hours after surgery corresponding to the time when the physiological effect of our dexamethasone intervention declines
Moderate to severe pain Visual analogue scale VAS 30 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty THA but all have done so with a postoperative injection of low dose steroids No previous studies have to our knowledge investigated the effects of repeat dosing after a preoperative high dose of steroid and none focused on patients selected by their postoperative pain response In spite of many studies and systematic reviews on the subject the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids who have a high postoperative pain response in a FAST-TRACK perioperative setting Oral administration of the repeat dose will allow for possible early discharge in future clinical settings
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery when compared to single high dose preoperatively
Total Knee Arthroplasty TKA is suitable for FAST-TRACK surgery and is often performed as outpatient surgery with no hospital overnight stay
Challenges in FAST-TRACK surgery include postoperative pain nausea and vomiting PONV complications due to rescue-analgesics and surgical complications
Pain is a well-known clinical problem with up to 75 of TKA patients experiencing moderate to severe pain the first day after surgery and 30-40 still experiencing moderate to severe pain 2 weeks after surgery potentially delaying ambulation and recovery within the first weeks
The role of severe acute postoperative pain upon the development of chronic pain is debatable but important
Data from our recently finished study in High Pain Responders HPR defined as patients with a score above 20 on the Pain Catastrophizing Scale PCS receiving preoperative high dose dexamethasone Nielsen et al IN PREPARATION clinicaltrialsgov ID NCT03763734 EudraCT 2018-002635-23 VEK H-18034778 found a persistent moderate to severe pain in 40 of patients at time 48 hours after surgery corresponding to the time when the physiological effect of our dexamethasone intervention declines
Moderate to severe pain Visual analogue scale VAS 30 24 hours postoperatively during a 5-meter walk test was associated with relapse pain at 48 hours
Other studies have made attempts of investigating the effect of a repeated dose of steroids after TKA and Total Hip Arthroplasty THA but all have done so with a postoperative injection of low dose steroids No previous studies have to our knowledge investigated the effects of repeat dosing after a preoperative high dose of steroid and none focused on patients selected by their postoperative pain response In spite of many studies and systematic reviews on the subject the optimal timing and dose for steroid-intervention in TKA in different patient groups is still inadequately understood
The study conduct with a repeat moderate dose of steroids given as an oral tablet at 9-11 pm on the day after TKA surgery in patients receiving preoperative high dose steroids who have a high postoperative pain response in a FAST-TRACK perioperative setting Oral administration of the repeat dose will allow for possible early discharge in future clinical settings
The hypothesis is that a repeat moderate dose of glucocorticoid will reduce the postoperative pain on postoperative day 2 and cumulated pain day 2-3 after TKA surgery when compared to single high dose preoperatively
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None