NCT03231215

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at below P25 for not_applicable postoperative-pain

Timeline
Completed

Started Jul 2016

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 3, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2017

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2017

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

July 25, 2017

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 27, 2017

Completed
Last Updated

August 3, 2017

Status Verified

August 1, 2017

Enrollment Period

11 months

First QC Date

July 25, 2017

Last Update Submit

August 1, 2017

Conditions

Postoperative Pain

Outcome Measures

Primary Outcomes (1)

  • duration of postoperative analgesia (NRS)

    first patient request for analgesia or NRS 4 or more

    24 hrs postoperative

Study Arms (2)

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

DexamethasoneDRUG

dexamethasone + plain Bupivacaine injected epidurally.

Also known as: Decadrone
controlled groupdexamethasone group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Dexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

July 25, 2017

First Posted

July 27, 2017

Study Start

July 3, 2016

Primary Completion

June 1, 2017

Study Completion

July 1, 2017

Last Updated

August 3, 2017

Record last verified: 2017-08