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

NCT ID: NCT03231215

Last Updated: 2017-08-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-07-03

Study Completion Date

2017-07-31

Brief Summary

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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

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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.

Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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controlled group

Group І (control group): the patients received 15 ml epidural plain bupivacaine (0.5%) +2 ml normal saline Group (BS).

Group Type PLACEBO_COMPARATOR

Dexamethasone

Intervention Type DRUG

dexamethasone + plain Bupivacaine injected epidurally.

dexamethasone group

Group II (dexamethasone group):- the patients received 15 ml epidural plain bupivacaine (0.5%) + 8mg dexamethasone (2ml) Group (BD)

Group Type ACTIVE_COMPARATOR

Dexamethasone

Intervention Type DRUG

dexamethasone + plain Bupivacaine injected epidurally.

Interventions

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Dexamethasone

dexamethasone + plain Bupivacaine injected epidurally.

Intervention Type DRUG

Other Intervention Names

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Decadrone

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Assiut University

OTHER

Sponsor Role lead

Responsible Party

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Mohamed galal aly

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Other Identifiers

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17100211

Identifier Type: -

Identifier Source: org_study_id

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