Ignite Creation Date:
2024-05-06 @ 8:18 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06339151
Status:
RECRUITING
Last Update Posted:
2024-04-01
First Post:
2024-03-24
Brief Title:
Comparing Single Dose and Multiple Dose of Dexamethasone Post TKA
Sponsor:
Thammasat University Hospital
Organization:
Thammasat University Hospital
Study Overview
Official Title:
Efficacy of Intravenous Dexamethasone Injection Given 12 and 24 Hours for Pain After Total Knee Arthroplasty A Prospective Randomized Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-03
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 goal of this clinical trial is to investigate the efficacy of single dose and double dose of dexamethasone after primary total knee replacement
The main questions it aims to answer isare
Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement
Researchers will compare double dose of dexamethasone group to see if insert effects
Participants will describe the main tasks participants will be asked to do interventions theyll be given and use bullets if it is more than 2 items
The main questions it aims to answer isare
Does 24 hours-interval of double dose of dexamethasone have better analgesic effect than single dose and 12 hours interval of double dose of dexamethasone after primary total joint replacement
Researchers will compare double dose of dexamethasone group to see if insert effects
Participants will describe the main tasks participants will be asked to do interventions theyll be given and use bullets if it is more than 2 items
Detailed Description:
1 Randomized patients into 3 groups
Group 1 Patients received only Dexamethasone 015 mgkg IV before surgery
Group 2 Patients received Dexamethasone 015 mgkg IV before surgery and Dexamethasone 015 mgkg at 12 hours after surgery
Group 3 Patients received Dexamethasone 015 mgkg before surgery along and Dexamethasone 015 mgkg at 24 hours after surgery
2 Preemptive analgesia Alprazolam 05 mg 1 tablet Pregabalin 75 mg 1 tablet before bedtime Celecoxib 400 mg 1 tablet Omeprazole 20 mg 1 mg tablet Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery
3 The researcher will give an injection Dexamethasone 015 mgkg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery
4 Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 05 Bupivacaine 15 mg which does not contain morphine along with local anesthesia in the thigh area Adductor canal block with a mixture of 05 Bupivacaine 15 mg
5 All patients will undergo knee replacement surgery in the same manner
6 Periarticular cocktail injection The drug contains Tranexamic acid 10 mgkg Morphine 5 mg Adrenaline 05 mg 5 Bupivacaine 200 mg Marcaine 1 amp Ketorolac 30 mg 1 amp mixed with saline Normal saline until 75 ml of area is obtained The injection site is placed around the knee joint and knee capsule
7 After surgery the patient will stay in the recovery room for 2 hours to take care of their symptoms
8 Pain relievers after surgery include
Parecoxib Dynastat 40 mg injection every 12 hours for the first 2 days after knee replacement surgery then change the medicine to Celecoxib 400 mg 1 tablet after breakfast
Paracetamol 500 mg 2 tablets every 6 hours for the first 2 days after knee replacement surgery After that give Paracetamol 500 mg 2 tablets pro for pain every 6 hours
Pregabalin 75 mg 1 tablet po hs
Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points VAS-P score 4
Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours
Alprazolam 05 mg 1 tab po hs
Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery
9 Group 2 patients will receive Dexamethasone 015 mgkg as an injection after surgery at 12 hours and patients in Group 3 will receive Dexamethasone 015 mgkg as injection at 24 hours after surgery
Group 1 Patients received only Dexamethasone 015 mgkg IV before surgery
Group 2 Patients received Dexamethasone 015 mgkg IV before surgery and Dexamethasone 015 mgkg at 12 hours after surgery
Group 3 Patients received Dexamethasone 015 mgkg before surgery along and Dexamethasone 015 mgkg at 24 hours after surgery
2 Preemptive analgesia Alprazolam 05 mg 1 tablet Pregabalin 75 mg 1 tablet before bedtime Celecoxib 400 mg 1 tablet Omeprazole 20 mg 1 mg tablet Paracetamol 500 mg 2 tablets and 1 Ondansetron 4 mg 1 tablet at 1 hour before surgery
3 The researcher will give an injection Dexamethasone 015 mgkg injection form together with Cefazolin 1 gm injection form by the anesthesiologist 30 minutes before surgery
4 Spinal Anesthesia by an anesthesiologist before surgery The anesthetic component consists of 05 Bupivacaine 15 mg which does not contain morphine along with local anesthesia in the thigh area Adductor canal block with a mixture of 05 Bupivacaine 15 mg
5 All patients will undergo knee replacement surgery in the same manner
6 Periarticular cocktail injection The drug contains Tranexamic acid 10 mgkg Morphine 5 mg Adrenaline 05 mg 5 Bupivacaine 200 mg Marcaine 1 amp Ketorolac 30 mg 1 amp mixed with saline Normal saline until 75 ml of area is obtained The injection site is placed around the knee joint and knee capsule
7 After surgery the patient will stay in the recovery room for 2 hours to take care of their symptoms
8 Pain relievers after surgery include
Parecoxib Dynastat 40 mg injection every 12 hours for the first 2 days after knee replacement surgery then change the medicine to Celecoxib 400 mg 1 tablet after breakfast
Paracetamol 500 mg 2 tablets every 6 hours for the first 2 days after knee replacement surgery After that give Paracetamol 500 mg 2 tablets pro for pain every 6 hours
Pregabalin 75 mg 1 tablet po hs
Morphine 3 mg injection every 4 hours for patients with a pain score greater than 4 points VAS-P score 4
Ondansetron 4 mg IV prn for nausea and vomitting every 6 hours
Alprazolam 05 mg 1 tab po hs
Cefazolin 1 gm IV every 6 hours for the first 24 hours after surgery
9 Group 2 patients will receive Dexamethasone 015 mgkg as an injection after surgery at 12 hours and patients in Group 3 will receive Dexamethasone 015 mgkg as injection at 24 hours after surgery
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?:
False
Is an FDA AA801 Violation?:
None