Effect of Preoperative Steroid in Total Knee Arthroplasty

Arthropathy of Knee Clinical Trial

Official title:

The Effect of Preoperative Steroids Injection on Pain and Oedema After Total Knee Arthroplasty . A Double -Blinded Randomized Controlled Study.

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04084912
• Other study ID #: steroid injection in TKA
• Status: Not yet recruiting
• Phase: Phase 3
• Start date: January 1, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: December 2019
• Source: Assiut University
• Contact: David Nady, physician
• Phone: +2001203649367
• Email: david011183[@]med.au.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Detect the effect of preoperative steroid injection in total knee arthroplasty on post operative:

1. pain

2. oedema

3. nausea and vomiting

4. quadriceps power

5. knee flexion

6. wound complications

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 .

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 86
• Est. completion date: June 1, 2021
• Est. primary completion date: January 1, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Any patient scheduled for primary total knee replacement arthroplasty

Exclusion Criteria:

1. Diabetic patients

2. Rheumatoid arthritis patients

3. Patients on regular steroid therapy

4. Patients refused to be enrolled in the study

Related Conditions & MeSH terms

• Arthropathy of Knee
• Joint Diseases

Intervention

Drug:
• Dexamethasone Sodium Phosphate
intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg
• Saline Solution
intravenous injection of one ampoule saline

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (5)

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. Review. — View 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. Review. — View 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. — View 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. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	14 days
Secondary	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	14 days
Secondary	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.	14 days
Secondary	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.	14 days
Secondary	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	14 days