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Pre-emptive Dexamethasone in Hip Arthroplasty

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Egypt
Study Type
Interventional
Intervention
Normal saline
Dexamethasone
Sponsored by
Tanta University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Postoperative Pain focused on measuring Dexamethasone, Hip arthroplasty, Postoperative pain

Eligibility Criteria

21 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Faculty of Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Control Group

Dexamethasone Group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Postoperative pain score
Postoperative Numerical Rating score (NRS) will be assessed every 2 hours in the first six hours, then every 6 hours till 24 hour.

Full Information

First Posted
May 19, 2021
Last Updated
February 1, 2023
Sponsor
Tanta University
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1. Study Identification

Unique Protocol Identification Number
NCT04898920
Brief Title
Pre-emptive Dexamethasone in Hip Arthroplasty
Official Title
The Effect of Pre-emptive Dexamethasone on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
May 23, 2021 (Actual)
Primary Completion Date
January 28, 2023 (Actual)
Study Completion Date
January 28, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
Detailed Description
- This randomized controlled prospective study will be carried out on 70 adult patients aged 21 to 75 years admitted to orthopedic operating rooms in Tanta University Hospital for hip surgery under spinal anesthesia. I Patients will be randomly distributed into two equal groups using the computer-generated software. 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. 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. All the patients will undergo standardized preoperative assessment consisted of history taking, general and regional examination, and requesting preoperative investigations including (complete blood count (CBC), coagulation profile, and renal function tests). Upon patient admission to the operating theater, they will be attached to a monitor consisting of pulse oximetry, 5 lead ECG, non-invasive blood pressure, end-tidal carbon dioxide (Co2), and temperature. Then, intravenous access will be established through the insertion of an 18-gauge peripheral venous cannula, then, lactated ringer solution 7ml/kg over 30 minutes will be started. All the equipment required for spinal anesthesia, general anesthesia, and nerve block will be prepared by an expert anesthesiologist who will not be participating in this research. Also, the resuscitation equipment will be prepared before starting anesthesia. Under complete aseptic precautions and local anesthetic skin infiltration with 3 ml lidocaine 1% at L3-L4 or L4-L5 intervertebral space, midline approach spinal anesthesia will be performed using a 25 G spinal needle. Once intrathecal placement will be confirmed, a mixture of 2 ml of hyperbaric bupivacaine (10 mg) and 0.5 ml of fentanyl (25 ugs) will be injected. The patient will be monitored for the hemodynamic parameters including the heart rate and the mean arterial pressure every 3 minutes. Moreover, the sensory and motor blockade will be assessed. Oxygen will be applied to the patient with the aid of an oxygen mask at a flow rate of 4 L/min. The pinprick test from caudal to cephalic direction using a 26-gauge needle will be used to evaluate the sensory block until the sensory level reached the level of T11 or higher. The motor block will be assessed every 5 minutes by the Bromage score (grade 3: no movement, grade 2: unable to flex knees and can flex ankle, grade 1: unable to raise an extended leg but able to move the knees and ankles, grade 0: no paralysis) until reaching a score of 2 or 3. If no adequate sensory or motor blockade will be obtained within 20 minutes, the patient will receive general anesthesia and be excluded from the study. A decrease in the heart rate below 50 b/min will be managed by atropine 0.3 mg i.v, while a decrease in the mean arterial pressure below 65 mmHg will be managed by 10 mg ephedrine i.v and intravenous fluids. Primary outcome will be postoperative morphine consumption and the secondary outcome will be the postoperative pain score

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
Dexamethasone, Hip arthroplasty, Postoperative pain

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Masking Description
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.
Allocation
Randomized
Enrollment
83 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Control Group
Arm Type
Placebo Comparator
Arm Description
The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
Arm Title
Dexamethasone Group
Arm Type
Experimental
Arm Description
Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
Placebo
Intervention Description
The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
Intervention Type
Drug
Intervention Name(s)
Dexamethasone
Other Intervention Name(s)
Active group
Intervention Description
Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
Primary Outcome Measure Information:
Title
Postoperative morphine consumption
Description
The total dose of morphine in mg consumed in the first 24 hours after surgery
Time Frame
The first postoperative day
Secondary Outcome Measure Information:
Title
Postoperative pain score
Description
Postoperative Numerical Rating score (NRS) will be assessed every 2 hours in the first six hours, then every 6 hours till 24 hour.
Time Frame
The first postoperative day

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery Exclusion Criteria: Patients who refused to participate in the research Suspected or diagnosed coagulopathy Allergy to bupivacaine With major cardiac, renal, or hepatic disorders
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sameh Abdelkhalik, M.D
Organizational Affiliation
Faculty of Medicine, Tanta University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Faculty of Medicine
City
Tanta
State/Province
Algharbia
ZIP/Postal Code
31511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
IPD Sharing 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.
IPD Sharing Access Criteria
Contact the principal investigator

Learn more about this trial

Pre-emptive Dexamethasone in Hip Arthroplasty

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