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Effect of Preoperative Steroid in Total Knee Arthroplasty

NCT ID: NCT04084912

Last Updated: 2019-12-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE3

Total Enrollment

86 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-01

Study Completion Date

2021-06-01

Brief Summary

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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

Detailed Description

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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 .

Conditions

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Arthropathy of Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers

Study Groups

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Dexamethasone group

this group will receive one ampoule Intravenous injection of Dexamethasone Sodium Phosphate 2 ml . 8 mg once by the anesthesiologist immediately before skin incision

Group Type ACTIVE_COMPARATOR

Dexamethasone Sodium Phosphate

Intervention Type DRUG

intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg

Placebo group

this group will receive one ampoule Intravenous injection of Saline once by the anesthesiologist immediately before skin incision

Group Type PLACEBO_COMPARATOR

Saline Solution

Intervention Type DRUG

intravenous injection of one ampoule saline

Interventions

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Dexamethasone Sodium Phosphate

intravenous injection of one ampoule dexamethasone Sodium phosphate 2 ml 8 mg

Intervention Type DRUG

Saline Solution

intravenous injection of one ampoule saline

Intervention Type DRUG

Other Intervention Names

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Steroid saline

Eligibility Criteria

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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
Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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DNKameel

physician

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hatem Bakr, asst. prof

Role: STUDY_CHAIR

Assiut University

Central Contacts

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David Nady, physician

Role: CONTACT

Phone: +2001203649367

Email: [email protected]

mohammed abdelnasser, Doctor

Role: CONTACT

Phone: +2001002438664

Email: [email protected]

References

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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.

Reference Type BACKGROUND
PMID: 28614237 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25564196 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29481989 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28614232 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 28655354 (View on PubMed)

Other Identifiers

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steroid injection in TKA

Identifier Type: -

Identifier Source: org_study_id