Post Operative Pain, AcuteNCT07046325
Comparison Between Dexametidomedine\Bupivacaine and Plain Bupivacaine in Superior Trunk Block for Arthroscopic Shoulder Surgeries
A study testing dexametedomidine and Bupivacain in people with Post Operative Pain, Acute and Arthroscopic Shoulder Surgery, run by Ain Shams University at 1 site in Egypt.
Trial summary
Comparison between dexametidomedine\bupivacaine and plain bupivacaine in superior trunk block for arthroscopic shoulder surgeries Read more about this study
- Who is it for?
- Ages 20 to 50 years
- Conditions the study is for
- Post Operative Pain, Acute, Arthroscopic Shoulder Surgery
- What is being tested?
- dexametedomidine and Bupivacain
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2025to 1 May 2025
- 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 20 to 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age ;20-50 years old
- Both genders
- American Society of Anesthesiologists physical status I and II
- BMI less than 30
- Arthroscopic shoulder surgeries.
Who cannot join
- Patients with ASA more than II
- Patients with a sepsis, malignancy anywhere
- Patient with bleeding tendencies or on anticoagulation therapy
- Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
- Allergy to study drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Comparison between dexametidomedine\bupivacaine and plain bupivacaine in superior trunk block for arthroscopic shoulder surgeries
Read the detailed description
This study will be conducted to investigate the efficacy of adding dexmedetomidine in STB for postoperative analgesia in patients undergoing arthroscopic shoulder surgery.
- Inclusion Criteria:
- age ;20-50 years old of both genders
- American Society of Anesthesiologists physical status I and II
- BMI less than 30
- Arthroscopic shoulder surgeries.
- Exclusion Criteria:
- Patients with ASA more than II
- Patients with a sepsis, malignancy anywhere
- Patient with bleeding tendencies or on anticoagulation therapy
- Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
- Allergy to study drugs.
Study groups:
The patients will be randomized into 2 groups:
- Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.
- Group B: are administered Ultrasound guided STB with bupivacaine.
Primary outcome:
Duration of analgesia of Superior trunck block.
Secondary outcome:
- Cumulative dose of postoperative consumption of the rescue analgesia during 24h after STB
- Durations of motor blockade (DOM)
- Residual block related neurological symptoms
- Hemodynamic variables
- Dyspnea and sedation scale.
- Being tested
- dexametedomidine, Bupivacain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dexametedomidineDrug
- Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.
BupivacainDrug
- Group B: are administered Ultrasound guided STB with bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| group B | Active comparator | group administered Ultrasound guided STB with bupivacaine Receives: Drug: Bupivacain |
| group DB | Active comparator | group administered Ultrasound guided STB with bupivacaine and dexametidomedine. Receives: Drug: dexametedomidine; Drug: Bupivacain |
What is being measured
The primary outcome is the main question the study is designed to answer.
Duration of analgesia of Superior trunck block.
The DOA will be defined as the time interval between STB and the first need for the rescue analgesics.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2025
- Study start20 Jan 2025
- Primary completion20 Apr 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- More trials run by Ain Shams 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ain Shams University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- fagr fathy abdo, Medical Doctorate, Principal investigator, Ain Shams University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07046325
- Sponsor's protocol ID
- FMASU R112/2025
- Status last verified
- May 2025
- First submitted
- 15 Jun 2025
- Last updated
- 1 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Dexametidomedine\Bupivacaine and Plain Bupivacaine in Superior Trunk Block for Arthroscopic Shoulder Surgeries
- ClinicalTrials.gov ID
- NCT07046325
- Acronym / sponsor ID
- FMASU R112/2025
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Ain Shams UniversityUniversity, hospital or other
- Study start
- 20 Jan 2025 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 1 Jul 2025 (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.
Comparison between dexametidomedine\bupivacaine and plain bupivacaine in superior trunk block for arthroscopic shoulder surgeries
Detailed description
This study will be conducted to investigate the efficacy of adding dexmedetomidine in STB for postoperative analgesia in patients undergoing arthroscopic shoulder surgery.
- Inclusion Criteria:
- age ;20-50 years old of both genders
- American Society of Anesthesiologists physical status I and II
- BMI less than 30
- Arthroscopic shoulder surgeries.
- Exclusion Criteria:
- Patients with ASA more than II
- Patients with a sepsis, malignancy anywhere
- Patient with bleeding tendencies or on anticoagulation therapy
- Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
- Allergy to study drugs.
Study groups:
The patients will be randomized into 2 groups:
- Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine.
- Group B: are administered Ultrasound guided STB with bupivacaine.
Primary outcome:
Duration of analgesia of Superior trunck block.
Secondary outcome:
- Cumulative dose of postoperative consumption of the rescue analgesia during 24h after STB
- Durations of motor blockade (DOM)
- Residual block related neurological symptoms
- Hemodynamic variables
- Dyspnea and sedation scale.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| group B | Active comparator | Drug: Bupivacaingroup administered Ultrasound guided STB with bupivacaine |
| group DB | Active comparator | Drug: dexametedomidine, Drug: Bupivacaingroup administered Ultrasound guided STB with bupivacaine and dexametidomedine. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age ;20-50 years old
- Both genders
- American Society of Anesthesiologists physical status I and II
- BMI less than 30
- Arthroscopic shoulder surgeries.
Key exclusion criteria (5 listed)
- Patients with ASA more than II
- Patients with a sepsis, malignancy anywhere
- Patient with bleeding tendencies or on anticoagulation therapy
- Patients with pre-existing neurologic deficit or neuropathy affecting brachial plexus
- Allergy to study drugs.
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 |
|---|---|---|
| dexametedomidine1. Group DB: are administered Ultrasound guided STB with bupivacaine and dexametidomedine. | Drug | group DB |
| Bupivacain2. Group B: are administered Ultrasound guided STB with bupivacaine. | Drug | group B, group DB |
Primary outcome
Duration of analgesia of Superior trunck block.
Time frame: 24 hours
The DOA will be defined as the time interval between STB and the first need for the rescue analgesics.
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 1 Jul 2025.
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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.
fagr fathy abdo, Medical Doctorate principal investigator
Ain Shams 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 dexametedomidine and Bupivacain in people with Post Operative Pain, Acute and Arthroscopic Shoulder Surgery, run by Ain Shams 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 5 inclusion and 5 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 1 Jul 2025. 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.
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?
Duration of analgesia of Superior trunck block. (time frame: 24 hours). 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 1 Jul 2025.