Postoperative AnalgesiaPhase 4IBBBNCT03940469
Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Interscalene Block
A Phase 4 study testing Saline, Dexamethasone Injection and Dexmedetomidine Hydrochloride in people with Postoperative Analgesia and Postoperative Complications, run by Menoufia University at 1 site in Egypt.
Trial summary
The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Analgesia, Postoperative Complications
- What is being tested?
- Saline, Dexamethasone Injection and Dexmedetomidine Hydrochloride
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 3 Jul 2016to 1 Jan 2019
- Phase
- Phase 4
- 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 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Sixty healthy patients ASA I-II
- Aged 18-60 years
- Of both sexes
- Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.
Who cannot join
- Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
- All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
- Pregnant women
- Psychiatric patients
- Patients with a previous history or clinical evidence of central or peripheral neurological disease
- Coagulopathy or anticoagulant/antiaggregant therapy
Show all 9Show fewer
- Contralateral phrenic nerve paresis
- Patients who have an infection at the site of the block.
- Every patient who had an anatomical or vascular abnormality in the upper extremity were excluded from this study.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.
Read the detailed description
Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.
- Being tested
- Saline, Dexamethasone Injection, Dexmedetomidine Hydrochloride
- Keywords
- Dexmedetomidine, Dexamethasone, Interscalene
- Medical subject headings
- Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SalineDrug
Also called normal saline
2 ml normal saline
Dexamethasone InjectionDrug
Also called dexamethsone
8 mg dexamethasone
Dexmedetomidine HydrochlorideDrug
Also called dexmedetomidine
100 microgram dexmedetomidine
| Study group | Role | What they receive |
|---|---|---|
| Control group | Placebo comparator | received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Receives: Drug: Saline |
| Dexamethasone group | Active comparator | received 35ml levobupivacaine+8mg dexamethasone Receives: Drug: Dexamethasone Injection |
| Dexmeteomidine group | Active comparator | received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. Receives: Drug: Dexmedetomidine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in postoperative analgesia
Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).
Measured: During first 2 days after surgery
Secondary outcomes (3)
Postoperative analgesic requirement
Total amount of paracetamol required in mg
Measured: During first 2 days after surgery
Hemodynamic parameter
Heart rate
Measured: During first 2 days after surgery
Hemodynamic parameter
Mean arterial blood pressure
Measured: During first 2 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2019
- Study start3 Jul 2016
- Primary completion1 Jan 2019
- Study completion1 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative AnalgesiaStudies of the same condition, open and under way.
- More trials run by Menoufia 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Collaborators
- Mamdoh Elsayed Lotfy, Osama Abdallah Elsharkawy, Basma Abdelhamid Fathy
- Responsible party
- Principal investigator, ashraf magdy eskandr, Menoufia University
- Investigators
- mamdouh e lotfy, m.d., Study director, emeritus professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03940469
- Sponsor's protocol ID
- Interscalene Dexmedetomidine
- Acronym
- IBBB
- Status last verified
- May 2019
- First submitted
- 10 Apr 2019
- Last updated
- 7 May 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexmedetomidine Versus Dexamethasone With Levobupivacaine in Ultrasound Guided Interscalene Block During Shoulder Arthroscopy: A Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT03940469
- Acronym / sponsor ID
- IBBB / Interscalene Dexmedetomidine
- Keywords
- Dexmedetomidine, Dexamethasone, Interscalene
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Collaborators
- Mamdoh Elsayed Lotfy, Osama Abdallah Elsharkawy, Basma Abdelhamid Fathy
- Study start
- 3 Jul 2016 (actual)
- Primary completion
- 1 Jan 2019 (actual)
- Study completion
- 1 Jan 2019 (actual)
- First posted
- 7 May 2019 (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.
The investigators compared between dexamethasone and dexmedetomidine when added to levobupivacaine in the quality and duration of ultrasound-guided interscalene block during shoulder arthroscopy.
Detailed description
Sixty patients were enrolled and divided into three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. The primary outcome was the postoperative pain which was assessed by Visual analog score(VAS), the secondary outcomes were the onset and duration of sensory and motor block, the total amount of analgesic requirement, and blood cortisol level.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- three groups 20 each, Group C received 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. Group H received 35ml levobupivacaine+8mg dexamethasone under ultrasound guided interscalene block. Group D received 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline.
| Arm | Type | Receives |
|---|---|---|
| Control group | Placebo comparator | Drug: Salinereceived 35ml levobupivacaine+2ml normal saline under ultrasound guided interscalene block. |
| Dexamethasone group | Active comparator | Drug: Dexamethasone Injectionreceived 35ml levobupivacaine+8mg dexamethasone |
| Dexmeteomidine group | Active comparator | Drug: Dexmedetomidine Hydrochloridereceived 35ml levobupivacaine+100umg dexmedetomidine+1ml normal saline. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Sixty healthy patients ASA I-II
- Aged 18-60 years
- Of both sexes
- Scheduled for shoulder arthroscopy using ultrasound interscalene block were enrolled.
Key exclusion criteria (9 listed)
- Patients with a history of any allergic reactions to levobupivacaine, dexamethasone or α2 agonists
- All patients with hypertension, cardiac, hepatic, renal or pulmonary diseases, - Patients who were under treatment by α2 agonist or antagonists
- Pregnant women
- Psychiatric patients
- Patients with a previous history or clinical evidence of central or peripheral neurological disease
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 |
|---|---|---|
| SalineAlso: normal saline2 ml normal saline | Drug | Control group |
| Dexamethasone InjectionAlso: dexamethsone8 mg dexamethasone | Drug | Dexamethasone group |
| Dexmedetomidine HydrochlorideAlso: dexmedetomidine100 microgram dexmedetomidine | Drug | Dexmeteomidine group |
Primary outcome
Changes in postoperative analgesia
Time frame: During first 2 days after surgery
Assessed by measuring severity of pain by visual analog score(score 0 to 10 cm with 0= no pain and 10=worst pain imaginable).
3 secondary outcomes
Postoperative analgesic requirement
Time frame: During first 2 days after surgery
Hemodynamic parameter
Time frame: During first 2 days after surgery
Hemodynamic parameter
Time frame: During first 2 days after surgery
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 7 May 2019.
- Individual participant dataSharing planned: No
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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.
mamdouh e lotfy, m.d. study director
emeritus professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Saline, Dexamethasone Injection and Dexmedetomidine Hydrochloride in people with Postoperative Analgesia and Postoperative Complications, run by Menoufia 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 4 inclusion and 9 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 7 May 2019. 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Changes in postoperative analgesia (time frame: During first 2 days after surgery). 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 7 May 2019.