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NCT03231215 Clinical Trial

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

Postoperative Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT03231215
Other study ID # 17100211
Secondary ID
Status Completed
Phase N/A
First received July 25, 2017
Last updated August 1, 2017
Start date July 3, 2016
Est. completion date July 2017

Study information
Verified date August 2017
Source Assiut University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 50
Est. completion date July 2017
Est. primary completion date June 2017
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Dexamethasone
dexamethasone + plain Bupivacaine injected epidurally.

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Assiut University

Outcome
Type Measure Description Time frame Safety issue
Primary duration of postoperative analgesia (NRS) first patient request for analgesia or NRS 4 or more 24 hrs postoperative
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