Effect of Preoperative Steroid in Total Knee Arthroplasty
Primary Purpose
Arthropathy of Knee
Status
Unknown status
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate
Saline Solution
Sponsored by
About this trial
This is an interventional treatment trial for Arthropathy of Knee
Eligibility Criteria
Inclusion Criteria:
- Any patient scheduled for primary total knee replacement arthroplasty
Exclusion Criteria:
- Diabetic patients
- Rheumatoid arthritis patients
- Patients on regular steroid therapy
- Patients refused to be enrolled in the study
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Dexamethasone group
Placebo group
Arm Description
this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision
this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision
Outcomes
Primary Outcome Measures
Postoperative pain summarized in the first 14 days
postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.
Secondary Outcome Measures
Postoperative Thigh circumference in the first 14 days
Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14
postoperative nausea and vomiting in the first 14 days
postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm.
postoperative knee flexion in the first 14 days
Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree.
Surgical wound infection in the first 14 days
wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04084912
Brief Title
Effect of Preoperative Steroid in Total Knee Arthroplasty
Official Title
The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2019
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2020 (Anticipated)
Primary Completion Date
January 1, 2021 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:
pain
oedema
nausea and vomiting
quadriceps power
knee flexion
wound complications
Detailed Description
Total knee arthroplasty has been identified as one of the most effective surgeries for knee arthritis. Many patients experience moderate to severe pain during the early postoperative period, as the surgery involves extensive bone resection and postsurgical serum levels of cytokine interleukin-6 and C-reactive protein may be elevated.Furthermore, many patients suffer postoperative nausea and vomiting after total knee arthroplasty . The inflammatory response after TKA is pronounced and a result of cumulative effects of anaesthesia and mechanical stress . Inadequate management of postoperative pain is relevant with a series of undesirable effects, including progression to a persistent pain, delayed functional recovery, increased the economic burden and patient dissatisfaction. Steroids may be associated with decreased levels of interleukin-6 and C reactive protein and may, thus, relieve the pain associated with surgery. Dexamethasone is a long-acting glucocorticoid that has been reported to inhibit peripheral phospholipase A, which decreases the pain-aggravating agents from the cyclooxygenase and lipoxygenase pathways . In addition, it reduces postoperative nausea and vomiting by exerting a central antiemetic effect by inhibiting prostaglandin synthesis and the release of endogenous opioids[5] . Some studies also reported potential adverse events, such as infection .
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthropathy of Knee
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Allocation
Randomized
Enrollment
86 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Dexamethasone group
Arm Type
Active Comparator
Arm Description
this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate
Other Intervention Name(s)
Steroid
Intervention Description
intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
Intervention Type
Drug
Intervention Name(s)
Saline Solution
Other Intervention Name(s)
saline
Intervention Description
intravenous injection of one ampoule saline
Primary Outcome Measure Information:
Title
Postoperative pain summarized in the first 14 days
Description
postoperative pain summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery pain is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no pain and 100 is the worst pain one can imagine Moderate pain is considered a VAS >30 mm.
Time Frame
14 days
Secondary Outcome Measure Information:
Title
Postoperative Thigh circumference in the first 14 days
Description
Postoperative oedema will be assessed for all participants by measuring Thigh circumference 1 cm above the upper pole of the patella postoperatively at day 1,2,3 and 14
Time Frame
14 days
Title
postoperative nausea and vomiting in the first 14 days
Description
postoperative nausea and vomiting summarized over first 14 days after surgery , assessed by a summation of Visual Analog Scale (VAS)-scores at day 1 , day 2 , day 3 and day 14 after surgery Nausea and vomiting is monitored by Visual Analog Scale (VAS) 0-100 mm, where 0 is no nausea nor vomiting and 100 is the worst nausea and vomiting one can imagine Moderate pain is considered a VAS >30 mm.
Time Frame
14 days
Title
postoperative knee flexion in the first 14 days
Description
Knee flexion assessed over first 14 days after surgery assessed by knee range of motion measured by goniometer where straight knee joint measure 0 degree.
Time Frame
14 days
Title
Surgical wound infection in the first 14 days
Description
wound complications like infection to be reported: redness, discharge, infection, dehiscence, delayed healing (up to 2 wks) postoperatively
Time Frame
14 days
10. Eligibility
Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Any patient scheduled for primary total knee replacement arthroplasty
Exclusion Criteria:
Diabetic patients
Rheumatoid arthritis patients
Patients on regular steroid therapy
Patients refused to be enrolled in the study
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
David Nady, physician
Phone
+2001203649367
Email
david011183@med.au.edu.eg
First Name & Middle Initial & Last Name or Official Title & Degree
mohammed abdelnasser, Doctor
Phone
+2001002438664
Email
abdelnasser.m.k@med.au.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hatem Bakr, asst. prof
Organizational Affiliation
Assiut University
Official's Role
Study Chair
12. IPD Sharing Statement
Citations:
PubMed Identifier
28614237
Citation
Xing LZ, Li L, Zhang LJ. Can intravenous steroid administration reduce postoperative pain scores following total knee arthroplasty?: A meta-analysis. Medicine (Baltimore). 2017 Jun;96(24):e7134. doi: 10.1097/MD.0000000000007134.
Results Reference
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PubMed Identifier
25564196
Citation
Rytter S, Stilling M, Munk S, Hansen TB. Methylprednisolone reduces pain and decreases knee swelling in the first 24 h after fast-track unicompartmental knee arthroplasty. Knee Surg Sports Traumatol Arthrosc. 2017 Jan;25(1):284-290. doi: 10.1007/s00167-014-3501-8. Epub 2015 Jan 7.
Results Reference
background
PubMed Identifier
29481989
Citation
Fan Z, Ma J, Kuang M, Zhang L, Han B, Yang B, Wang Y, Ma X. The efficacy of dexamethasone reducing postoperative pain and emesis after total knee arthroplasty: A systematic review and meta-analysis. Int J Surg. 2018 Apr;52:149-155. doi: 10.1016/j.ijsu.2018.02.043. Epub 2018 Feb 23.
Results Reference
background
PubMed Identifier
28614232
Citation
Meng J, Li L. The efficiency and safety of dexamethasone for pain control in total joint arthroplasty: A meta-analysis of randomized controlled trials. Medicine (Baltimore). 2017 Jun;96(24):e7126. doi: 10.1097/MD.0000000000007126.
Results Reference
background
PubMed Identifier
28655354
Citation
Yue C, Wei R, Liu Y. Perioperative systemic steroid for rapid recovery in total knee and hip arthroplasty: a systematic review and meta-analysis of randomized trials. J Orthop Surg Res. 2017 Jun 27;12(1):100. doi: 10.1186/s13018-017-0601-4.
Results Reference
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Effect of Preoperative Steroid in Total Knee Arthroplasty
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