The Effect of Adding Dexamethasone to Epidural Bupivacain... | NCT03231215

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

NCT03231215

Sponsor

Assiut University

Status

Completed

Last Update Posted

Aug 3, 2017Actual

Enrollment

50Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

Dexamethasone

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 3, 2016Actual

Primary Completion Date

Jun 2017Actual

Completion Date

Jul 2017Actual

First Submitted Date

Jul 25, 2017

First Submission Date that Met QC Criteria

Jul 25, 2017

First Posted Date

Jul 27, 2017Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 1, 2017

Last Update Posted Date

Aug 3, 2017Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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:

Pain score (NRS) at base line, then every 4 hrs for 24 hrs.
Frequency of rescue analgesia.
Postoperative side effects like nausea, vomiting, and over sedation.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

50Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Dexamethasone	Drug	dexamethasone + plain Bupivacaine injected epidurally.	controlled group dexamethasone group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
duration of postoperative analgesia (NRS)	first patient request for analgesia or NRS 4 or more	24 hrs postoperative

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D003907	Dexamethasone

Ancestor Terms

ID	Term
D011246	Pregnadienetriols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids

Browse Leaves

Not provided

Browse Branches

Not provided