Trauma InjuryPhase 1NCT06304909
Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block
A Phase 1 study testing Dexmedetomidine injection, Dexamethasone and Saline in people with Trauma Injury, run by Assiut University at 1 site in Egypt.
Trial summary
Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block. Read more about this study
- Who is it for?
- Ages 20 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Trauma Injury
- What is being tested?
- Dexmedetomidine injection, Dexamethasone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 111 participants
- Where
- 1 siteEgypt
- Study dates
- 15 May 2024to 20 Mar 2025
- Phase
- Phase 1
- 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 20 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Patients between 20_60 years old
- Patients with ASA clinical status I/II
- Patients scheduled for peripheral nerve block for upper extremity surgery
Who cannot join
- 1) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine \& dexamethasone
Trial locations and contacts
1 site in 1 country.
About this study
Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.
- Conditions
- Trauma Injury
- Being tested
- Dexmedetomidine injection, Dexamethasone, Saline
- Medical subject headings
- Accidental Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexmedetomidine injectionDrug
Dexmedetomidine group will receive 0.5 mcg/kg
DexamethasoneDrug
Dexamethasone group will receive 8mg/kg
SalineDrug
receive equivalent volume of saline 0.9%.
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine group will receive 0.5 mcg/kg | Experimental | Not described Receives: Drug: Dexmedetomidine injection |
| Dexamethasone group will receive 8mg/kg | Experimental | Not described Receives: Drug: Dexamethasone |
| Control group will receive equivalent volume of saline 0.9%. | Experimental | Not described Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of rebound pain.
Rebound pain is defined as an increase from well-controlled to severe pain typically within 12_24 h of resolution of the nerve block.
Measured: 1year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2024
- Study start15 May 2024
- Primary completion10 Mar 2025
- Study completion20 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for Trauma InjuryStudies of the same condition, open and under way.
- More trials run by Assiut 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa Sayed Mohamed Ahmed, Assiut University
- Investigators
- Wesam Nashat Ali, professor, Study director, Assistant professor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06304909
- Sponsor's protocol ID
- 2080278
- Status last verified
- Jun 2026
- First submitted
- 5 Mar 2024
- Last updated
- 24 Jun 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kolny M, Stasiowski MJ, Zuber M, Marciniak R, Chabierska E, Pluta A, Jalowiecki P, Byrczek T. Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Anaesthesiol Intensive Ther. 2017;49(1):47-52. doi: 10.5603/AIT.2017.0009.
PubMed 28362032Brattwall M, Jildenstal P, Warren Stomberg M, Jakobsson JG. Upper extremity nerve block: how can benefit, duration, and safety be improved? An update. F1000Res. 2016 May 18;5:F1000 Faculty Rev-907. doi: 10.12688/f1000research.7292.1. eCollection 2016.
PubMed 27239291Falgas N, Sanchez-Valle R, Bargallo N, Balasa M, Fernandez-Villullas G, Bosch B, Olives J, Tort-Merino A, Antonell A, Munoz-Garcia C, Leon M, Grau O, Castellvi M, Coll-Padros N, Rami L, Redolfi A, Llado A. Hippocampal atrophy has limited usefulness as a diagnostic biomarker on the early onset Alzheimer's disease patients: A comparison between visual and quantitative assessment. Neuroimage Clin. 2019;23:101927. doi: 10.1016/j.nicl.2019.101927. Epub 2019 Jul 5.
PubMed 31491836Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.
PubMed 33551124Bhatia P, Metta R. Rebound pain: Undesired, yet unexplored. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):527-528. doi: 10.4103/joacp.joacp_435_22. Epub 2022 Dec 26. No abstract available.
PubMed 36778810Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
PubMed 17695343Hong B, Oh C, Jo Y, Chung W, Park E, Park H, Yoon S. The Effect of Intravenous Dexamethasone and Dexmedetomidine on Analgesia Duration of Supraclavicular Brachial Plexus Block: A Randomized, Four-Arm, Triple-Blinded, Placebo-Controlled Trial. J Pers Med. 2021 Dec 1;11(12):1267. doi: 10.3390/jpm11121267.
PubMed 34945739
Study at a glance
From the registry record, last updated by the sponsor on 24 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Dexmedetomidine Versus Dexamethasone for Management of Repound Pain After Supraclavicular Brachial Plexus Block
- ClinicalTrials.gov ID
- NCT06304909
- Acronym / sponsor ID
- 2080278
- Conditions
- Trauma Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 May 2024 (actual)
- Primary completion
- 10 Mar 2025 (actual)
- Study completion
- 20 Mar 2025 (actual)
- First posted
- 12 Mar 2024 (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.
Effect of intravenous dexmedetomidine versus dexamethasone for management of repound pain after supraclavicular brachial plexus block.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine group will receive 0.5 mcg/kg | Experimental | Drug: Dexmedetomidine injection |
| Dexamethasone group will receive 8mg/kg | Experimental | Drug: Dexamethasone |
| Control group will receive equivalent volume of saline 0.9%. | Experimental | Drug: Saline |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Patients between 20_60 years old
Key exclusion criteria (1 listed)
- 1) they refused to participate 2) had preexisting neuropathy of the surgical limb 3) hypersensitivity to amide anesthetic 4) significant pulmonary disease 5) coagulopathy 6) sepsis 7) infection at the block site 8) hypersensitivity to dexmedetomidine \& dexamethasone
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 |
|---|---|---|
| Dexmedetomidine injectionDexmedetomidine group will receive 0.5 mcg/kg | Drug | Dexmedetomidine group will receive 0.5 mcg/kg |
| DexamethasoneDexamethasone group will receive 8mg/kg | Drug | Dexamethasone group will receive 8mg/kg |
| Salinereceive equivalent volume of saline 0.9%. | Drug | Control group will receive equivalent volume of saline 0.9%. |
Primary outcome
The incidence of rebound pain.
Time frame: 1year
Rebound pain is defined as an increase from well-controlled to severe pain typically within 12_24 h of resolution of the nerve block.
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 24 Jun 2026.
- Background: PubMed 28362032Kolny M, Stasiowski MJ, Zuber M, Marciniak R, Chabierska E, Pluta A, Jalowiecki P, Byrczek T. Randomized, comparative study of the effectiveness of three different techniques of interscalene brachial plexus block using 0.5% ropivacaine for shoulder arthroscopy. Anaesthesiol Intensive Ther. 2017;49(1):47-52. doi: 10.5603/AIT.2017.0009.
- Background: PubMed 27239291Brattwall M, Jildenstal P, Warren Stomberg M, Jakobsson JG. Upper extremity nerve block: how can benefit, duration, and safety be improved? An update. F1000Res. 2016 May 18;5:F1000 Faculty Rev-907. doi: 10.12688/f1000research.7292.1. eCollection 2016.
- Background: PubMed 31491836Falgas N, Sanchez-Valle R, Bargallo N, Balasa M, Fernandez-Villullas G, Bosch B, Olives J, Tort-Merino A, Antonell A, Munoz-Garcia C, Leon M, Grau O, Castellvi M, Coll-Padros N, Rami L, Redolfi A, Llado A. Hippocampal atrophy has limited usefulness as a diagnostic biomarker on the early onset Alzheimer's disease patients: A comparison between visual and quantitative assessment. Neuroimage Clin. 2019;23:101927. doi: 10.1016/j.nicl.2019.101927. Epub 2019 Jul 5.
- Background: PubMed 33551124Hamilton DL. Rebound pain: distinct pain phenomenon or nonentity? Br J Anaesth. 2021 Apr;126(4):761-763. doi: 10.1016/j.bja.2020.12.034. Epub 2021 Feb 5. No abstract available.
- Background: PubMed 36778810Bhatia P, Metta R. Rebound pain: Undesired, yet unexplored. J Anaesthesiol Clin Pharmacol. 2022 Oct-Dec;38(4):527-528. doi: 10.4103/joacp.joacp_435_22. Epub 2022 Dec 26. No abstract available.
- Background: PubMed 17695343Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
- Results publication: PubMed 34945739Hong B, Oh C, Jo Y, Chung W, Park E, Park H, Yoon S. The Effect of Intravenous Dexamethasone and Dexmedetomidine on Analgesia Duration of Supraclavicular Brachial Plexus Block: A Randomized, Four-Arm, Triple-Blinded, Placebo-Controlled Trial. J Pers Med. 2021 Dec 1;11(12):1267. doi: 10.3390/jpm11121267.
- 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.
Wesam Nashat Ali, professor study director
Assistant professor
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Dexmedetomidine injection, Dexamethasone and Saline in people with Trauma Injury, run by Assiut 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 3 inclusion and 1 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 24 Jun 2026. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The incidence of rebound pain. (time frame: 1year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06304909, which also lists 7 linked publications.
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 24 Jun 2026.