Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty

• Sponsor: Naestved Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05008367
• Collaborator: Copenhagen Trial Unit, Center for Clinical Intervention Research (Other)
• Enrollment: 485
• Locations: 5
• Arms: 3
• Actual Duration (Months): 20.8
• Patients Per Site: 97
• Patients Per Site Per Month: 4.7

Study Details

Study Description

Brief Summary

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Condition or Disease	Intervention/Treatment	Phase
Postoperative Pain	Drug: Dexamethasone; Drug: Isotonic saline	Phase 4

Detailed Description

Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial This explorative post-hoc analysis is a substudy of the DEX-2-TKA-trial (NCT03506789) investigating diffefferent subgroups of the patients included in the main trial.

Study Design

• Study Type: Interventional
• Actual Enrollment: 485 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effect of Dexamethasone as Analgesic Treatment After Total Knee Arthroplasty: Subgroup Analyses of The DEX-2-TKA Randomized Clinical Trial
• Actual Study Start Date: Sep 14, 2018
• Actual Primary Completion Date: Mar 11, 2020
• Actual Study Completion Date: Jun 7, 2020

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Treatment A 24 mg dexamethasone i.v. perioperatively and 24 mg dexamethasone i.v. on the first postoperative day	Drug: Dexamethasone; 24 mg intravenous Dexamethasone (6 ml)
Active Comparator: Treatment B 24 mg dexamethasone i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day	Drug: Dexamethasone; 24 mg intravenous Dexamethasone (6 ml); Drug: Isotonic saline; 6 ml of isotonic saline
Placebo Comparator: Placebo Placebo (isotonic saline) i.v. perioperatively and placebo (isotonic saline) i.v. on the first postoperative day	Drug: Isotonic saline; 6 ml of isotonic saline

Outcome Measures

Primary Outcome Measures

1. Cumulative usage of morphine 0-48 hours postoperatively [Time Frame: 0-48 hours postoperatively]

   Morphine administered both as patient-controlled analgesia (PCA) i.v. morphine 0-24 hours and oral morphine on demand 24-48 hours, and any other supplemental morphine administered postoperatively. Consumption in mg

Other Outcome Measures

1. Subgroup analysis on heterogeneity in intervention effect of age [Time Frame: 0-48 hours postoperatively]

   Age (years): > 65 vs. ≤ 65

2. Subgroup analysis on heterogeneity in intervention effect of sex [Time Frame: 0-48 hours postoperatively]

   Sex: male vs. female

3. Subgroup analysis on heterogeneity in intervention effect of ASA group [Time Frame: 0-48 hours postoperatively]

   ASA group classification: I+II vs. III

4. Subgroup analysis on heterogeneity in intervention effect of preoperative pain at rest [Time Frame: 0-48 hours postoperatively]

   VAS (mm): > 30 vs. ≤ 30

5. Subgroup analysis on heterogeneity in intervention effect of preoperative pain when active [Time Frame: 0-48 hours postoperatively]

   VAS (mm): > 30 vs. ≤ 30

6. Subgroup analysis on heterogeneity in intervention effect of type of anesthesia [Time Frame: 0-48 hours postoperatively]

   Type of anesthesia: spinal vs. general Anesthesia+Converted to general anesthesia

7. Subgroup analysis on heterogeneity in intervention effect of prior daily use (last month) of analgesic medication [Time Frame: 0-48 hours postoperatively]

   Prior daily use of paracetamol or NSAID: either parecetamol or NSAID vs. neither parecetamol or NSAID

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• Participation in the DEX-2-TKA-trial

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Gildhøj Privathospital	Brøndbyvester		Denmark	2605
2	Bispebjerg Hospital	Copenhagen		Denmark	2400
3	Sjællands Universitetshospital, Køge	Køge		Denmark	4600
4	Næstsved Sygehus	Næstved		Denmark	4700
5	Odense Universitetshospital	Odense		Denmark	5000

Sponsors and Collaborators

• Naestved Hospital
• Copenhagen Trial Unit, Center for Clinical Intervention Research

Investigators

None specified.

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 23, 2021

More Information

Publications

None provided.

• Responsible Party: Naestved Hospital
• ClinicalTrials.gov Identifier: NCT05008367
• Other Study ID Numbers: SM1-KAKG-2021
• First Posted: Aug 17, 2021
• Last Update Posted: Sep 13, 2021
• Last Verified: Sep 1, 2021

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Pain, Postoperative; Dexamethasone

Study Results

No Results Posted as of Sep 13, 2021