The Effect of Adding Dexamethasone to Epidural Bupivacaine for Total Knee Replacement Surgery

Not Applicable

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Dexamethasone

• Registration Number: NCT03231215
• Lead Sponsor: Assiut University

Brief Summary

The purpose of this study was to evaluate the efficacy of dexamethasone when added to epidural bupivacaine on the duration of postoperative analgesia in patients underwent total knee replacement surgery.

Detailed Description

Fifty patients underwent total knee replacement were included in the study. The patients (11 male and 39 female) were classified into two equal groups:- The patients received 15 mL plain bupivacaine + 2 mL (BS), or 8 mg dexamethasone (BD). The total volume injected in both groups was 17 ml.

Postoperative records:

1. Pain score (NRS) at base line, then every 4 hrs for 24 hrs.

2. Frequency of rescue analgesia.

3. Postoperative side effects like nausea, vomiting, and over sedation.

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Study Start: 2016-07-03
• Primary Completion: 2017-06
• Study Completion: 2017-07
• Study First Submitted: 2017-07-25
• Study First Submitted QC: 2017-07-25
• Study First Posted: 2017-07-27
• Status Verified: 2017-08
• Last Update Submitted: 2017-08-01
• Last Update Posted: 2017-08-03

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Patients scheduled for total knee replacement surgery.
2. ASA Physical status I,II,III.

Exclusion Criteria

1. Patients' refusal.
2. Uncooperative patients / Not able to understand pain assessment test.
3. Patients with history of allergy to the used drugs.
4. Significant liver disease.
5. Pregnancy.
6. Any contraindication for epidural anesthesia
7. Failed technique.

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
controlled group	Dexamethasone	Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).
dexamethasone group	Dexamethasone	Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)

Primary Outcome Measures

Name	Time	Method
duration of postoperative analgesia (NRS)	24 hrs postoperative	first patient request for analgesia or NRS 4 or more