NCT04898920

Brief Summary

  • Certain studies suggested that preoperative administration of systemic glucocorticoids in patients undergoing hip or knee arthroplasty surgery may improve the postoperative analgesia owing to their anti-inflammatory effect.
  • This study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta university hospitals for hip surgery under spinal anesthesia. Informed written consent will be obtained from each participant.
  • Patients will be randomly distributed into two equal groups using the computer-generated software.
  • Control Group: (35 patients) Those patients will receive 10 ml of normal saline before surgery.
  • Dexamethasone Group: (35 patients) Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
  • Primary outcome will be postoperative morphine consumption and the secondary outcome will be the postoperative pain score

Trial Health

87
On Track

Trial Health Score

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

Enrollment
83

participants targeted

Target at P50-P75 for not_applicable postoperative-pain

Timeline
Completed

Started May 2021

Typical duration for not_applicable postoperative-pain

Geographic Reach
1 country

1 active site

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

First Submitted

Initial submission to the registry

May 19, 2021

Completed
4 days until next milestone

Study Start

First participant enrolled

May 23, 2021

Completed
1 day until next milestone

First Posted

Study publicly available on registry

May 24, 2021

Completed
1.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 28, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 28, 2023

Completed
Last Updated

February 2, 2023

Status Verified

February 1, 2023

Enrollment Period

1.7 years

First QC Date

May 19, 2021

Last Update Submit

February 1, 2023

Conditions

Postoperative Pain

Keywords

DexamethasoneHip arthroplastyPostoperative pain

Outcome Measures

Primary Outcomes (1)

  • Postoperative morphine consumption

    The total dose of morphine in mg consumed in the first 24 hours after surgery

    The first postoperative day

Secondary Outcomes (1)

  • Postoperative pain score

    The first postoperative day

Study Arms (2)

Control Group

PLACEBO COMPARATOR

The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.

Drug: Normal saline

Dexamethasone Group

EXPERIMENTAL

Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

Drug: Dexamethasone

Interventions

Normal salineDRUG

The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.

Also known as: Placebo
Control Group
DexamethasoneDRUG

Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.

Also known as: Active group
Dexamethasone Group

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery

You may not qualify if:

  • Patients who refused to participate in the research
  • Suspected or diagnosed coagulopathy
  • Allergy to bupivacaine
  • With major cardiac, renal, or hepatic disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Medicine

Tanta, Algharbia, 31511, Egypt

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Saline SolutionDexamethasone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

Crystalloid SolutionsIsotonic SolutionsSolutionsPharmaceutical PreparationsPregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic CompoundsSteroids, Fluorinated

Study Officials

  • Sameh Abdelkhalik, M.D

    Tanta University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
Masking Details
* An anesthesia resident who will be blinded to the study groups and not participating in it will help in the preparation of uniform 10-ml syringes that contain normal saline in the control group and 16 mg dexamethasone in the other group to make the patient and care provider blinded to the group of the patient. * An assistant nurse who will be blinded to the study groups and will have no subsequent rule in it will help in the collection of the data of measurements to make the outcomes assessor blinded to the group of the patient.
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 19, 2021

First Posted

May 24, 2021

Study Start

May 23, 2021

Primary Completion

January 28, 2023

Study Completion

January 28, 2023

Last Updated

February 2, 2023

Record last verified: 2023-02

Data Sharing

IPD Sharing
Will share

The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.

Shared Documents
STUDY PROTOCOL, SAP, ICF
Time Frame
The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Access Criteria
Contact the principal investigator

Locations

EG(1)