Postoperative PainNCT04898920
Pre-emptive Dexamethasone in Hip Arthroplasty
A study testing Normal saline and Dexamethasone in people with Postoperative Pain, run by Tanta University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Normal saline and Dexamethasone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 83 participants
- Where
- 1 siteEgypt
- Study dates
- 23 May 2021to 28 Jan 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery
Who cannot join
- Patients who refused to participate in the research
- Suspected or diagnosed coagulopathy
- Allergy to bupivacaine
- With major cardiac, renal, or hepatic disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Pre-emptive Dexamethasone on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
- 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
Read the 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
- Conditions
- Postoperative Pain
- Being tested
- Normal saline, Dexamethasone
- Keywords
- Dexamethasone, Hip arthroplasty, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Normal salineDrug
Also called Placebo
The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery.
DexamethasoneDrug
Also called Active group
Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | The patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery. Receives: Drug: Normal saline |
| Dexamethasone Group | Experimental | Those patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery. Receives: Drug: Dexamethasone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
The total dose of morphine in mg consumed in the first 24 hours after surgery
Measured: The first postoperative day
Secondary outcomes (1)
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.
Measured: The first postoperative day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 May 2021
- Study start23 May 2021
- Primary completion28 Jan 2023
- Study completion28 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Tanta UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Tanta University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sameh Abdelkhalik Ahmed Ismaiel, Tanta University
- Investigators
- Sameh Abdelkhalik, M.D, Principal investigator, Tanta University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04898920
- Sponsor's protocol ID
- 34585/3/21
- Status last verified
- Feb 2023
- First submitted
- 19 May 2021
- Last updated
- 2 Feb 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Pre-emptive Dexamethasone on the Postoperative Analgesia After Total Hip Arthroplasty: Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04898920
- Acronym / sponsor ID
- 34585/3/21
- Conditions
- Postoperative Pain
- Keywords
- Dexamethasone, Hip arthroplasty, Postoperative pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Tanta UniversityUniversity, hospital or other
- Study start
- 23 May 2021 (actual)
- Primary completion
- 28 Jan 2023 (actual)
- Study completion
- 28 Jan 2023 (actual)
- First posted
- 24 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Drug: Normal salineThe patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery. |
| Dexamethasone Group | Experimental | Drug: DexamethasoneThose patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery. |
Who may qualify
- Ages
- 21 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients ASA II and III, aged 21 to 75 years, admitted for hip arthroplasty surgery
Key exclusion criteria (4 listed)
- Patients who refused to participate in the research
- Suspected or diagnosed coagulopathy
- Allergy to bupivacaine
- With major cardiac, renal, or hepatic disorders
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Normal salineAlso: PlaceboThe patients will receive 10 ml of normal saline as a placebo dexamethasone before surgery. | Drug | Control Group |
| DexamethasoneAlso: Active groupThose patients will receive 16 mg dexamethasone in 10 ml of normal saline before surgery. | Drug | Dexamethasone Group |
Primary outcome
Postoperative morphine consumption
Time frame: The first postoperative day
The total dose of morphine in mg consumed in the first 24 hours after surgery
1 secondary outcome
Postoperative pain score
Time frame: The first postoperative day
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2023.
- Individual participant dataSharing planned: Yes. The data of primary outcome will be available with the corresponding author till 6 months after approval of the publication of the trial.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sameh Abdelkhalik, M.D principal investigator
Tanta University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Normal saline and Dexamethasone in people with Postoperative Pain, run by Tanta University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative morphine consumption (time frame: The first postoperative day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2023.