Arthroscopic Shoulder SurgeriesPhase 4NCT07256938
Effect of Clonidine Additive to suprascapular_ Costoclavicular Versus Standard Interscalene Block in Arthroscopic Shoulder Surgeries
A Phase 4 study testing Bupivacaine 0.5% (hyperbaric), US-guided costoclavicular block and Interscalene brachial plexus block in people with Arthroscopic Shoulder Surgeries, run by Assiut University.
Trial summary
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Arthroscopic Shoulder Surgeries
- What is being tested?
- Bupivacaine 0.5% (hyperbaric), US-guided costoclavicular block and Interscalene brachial plexus block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- Dec 2025to Dec 2027
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- No healthy volunteers
- Adult
Who may be able to join
- ASA status 1,2,3. Age( 18-60) years Elective shoulder arthroscopic surgery under general anesthesia and nerve bloc performed preoperatively
Who cannot join
- Patient refusal Coagulation disorders. Anatomical disorders and/or neuropathic disease. BMI above 40. History of substance abuse. Chronic use of psychotropic and/or opioid. History of psychiatric diseases needing treatment. Contraindications to nerve block for shoulder surgery. Allergy to fentanil or any drug in the study protocol. Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).
About this study
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD.
Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks.
Read more
Hypothesis The main hypothesis of this study is that the addition of clonidine to suprascapular block combined with costoclavicular block is not inferior to the standard interscalene brachial plexus block in terms of postoperative analgesia. We postulate that pain score postoperatively and opioid requirements will not differ significantly in patients who receive either block.
Our secondary objectives will consist in looking at the differences in intraoperative , arm motor block , diaphragmatic paresis , patient satisfaction and time for readiness to discharge from PACU .we hypothesize that these outcomes will be similar in both groups , with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group The primary objective of this study will be to evaluate the postoperative pain score during arthroscopic shoulder surgery assessed by the pain score when comparing the effect of addition of clonidine to suprascapular_costoclavicular versus standard interscalene
- Conditions
- Arthroscopic Shoulder Surgeries
- Being tested
- Bupivacaine 0.5% (hyperbaric), US-guided costoclavicular block, Interscalene brachial plexus block, clonidine 1 mg / kg, single shot US-guided suprascapular nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bupivacaine 0.5% (hyperbaric)Drug
5 mL bupivacaine 0.5%,
US-guided costoclavicular blockProcedure or surgery
US-guided costoclavicular block
Interscalene brachial plexus blockProcedure or surgery
single shot US-guided interscalene brachial plexus block
clonidine 1 mg / kgDrug
clonidine 1 mg / kg
single shot US-guided suprascapular nerve blockProcedure or surgery
single shot US-guided suprascapular nerve block
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | US-guided costoclavicular block Receives: Drug: Bupivacaine 0.5% (hyperbaric); Procedure: US-guided costoclavicular block; Procedure: Interscalene brachial plexus block; Drug: clonidine 1 mg / kg |
| Group B | Active comparator | US-guided interscalene brachial plexus block Receives: Drug: Bupivacaine 0.5% (hyperbaric); Procedure: US-guided costoclavicular block; Drug: clonidine 1 mg / kg; Procedure: single shot US-guided suprascapular nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain score
to evaluate postoperative pain score during arthroscopic shoulder surgery assessed by the pain score when comparing the combined suprascapular and costoclavicular nerve blocks to the interscalene brachial plexus block
Measured: 24 hours postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2025
- Study startDec 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Shoulder SurgeriesStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Fathy Khedr, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07256938
- Sponsor's protocol ID
- clonidine + suprascapular
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 1 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Clonidine Additive to suprascapular_ Costoclavicular Versus Standard Interscalene Block in Arthroscopic Shoulder Surgeries
- ClinicalTrials.gov ID
- NCT07256938
- Acronym / sponsor ID
- clonidine + suprascapular
- Conditions
- Arthroscopic Shoulder Surgeries
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Dec 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 1 Dec 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.
Postoperative analgesia for shoulder surgery is typically achieved by providing an interscalene brachial plexus block. However, a very common side effect of this block is hemi-diaphragmatic paralysis, a state which may not be tolerated in patients with pulmonary conditions such as COPD.
Recently, clinicians have explored new ways to provide satisfactory analgesia while minimizing the pulmonary side effects of the interscalene nerve block. One of these solutions might be to offer the patient a suprascapular nerve block combined to costoclavicular block. Since these blocks are performed lower in the neck or under the clavicle, the phrenic nerve is less likely to be blocked. Thus, fewer respiratory side effects have been reported when using such blocks.
Hypothesis The main hypothesis of this study is that the addition of clonidine to suprascapular block combined with costoclavicular block is not inferior to the standard interscalene brachial plexus block in terms of postoperative analgesia. We postulate that pain score postoperatively and opioid requirements will not differ significantly in patients who receive either block.
Our secondary objectives will consist in looking at the differences in intraoperative , arm motor block , diaphragmatic paresis , patient satisfaction and time for readiness to discharge from PACU .we hypothesize that these outcomes will be similar in both groups , with the exception of a potential reduction in arm motor block and diaphragmatic paresis in the combined suprascapular and costoclavicular block group The primary objective of this study will be to evaluate the postoperative pain score during arthroscopic shoulder surgery assessed by the pain score when comparing the effect of addition of clonidine to suprascapular_costoclavicular versus standard interscalene
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Bupivacaine 0.5% (hyperbaric), Procedure: US-guided costoclavicular block, Procedure: Interscalene brachial plexus block, Drug: clonidine 1 mg / kgUS-guided costoclavicular block |
| Group B | Active comparator | Drug: Bupivacaine 0.5% (hyperbaric), Procedure: US-guided costoclavicular block, Drug: clonidine 1 mg / kg, Procedure: single shot US-guided suprascapular nerve blockUS-guided interscalene brachial plexus block |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- ASA status 1,2,3. Age( 18-60) years Elective shoulder arthroscopic surgery under general anesthesia and nerve bloc performed preoperatively
Key exclusion criteria (1 listed)
- Patient refusal Coagulation disorders. Anatomical disorders and/or neuropathic disease. BMI above 40. History of substance abuse. Chronic use of psychotropic and/or opioid. History of psychiatric diseases needing treatment. Contraindications to nerve block for shoulder surgery. Allergy to fentanil or any drug in the study protocol. Failure of nerve block performed in the preoperative block room when tested prior to entering the operating room (i.e. lack of loss of sensation to ice at the shoulder incision level).
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 |
|---|---|---|
| Bupivacaine 0.5% (hyperbaric)5 mL bupivacaine 0.5%, | Drug | Group A, Group B |
| US-guided costoclavicular blockUS-guided costoclavicular block | Procedure or surgery | Group A, Group B |
| Interscalene brachial plexus blocksingle shot US-guided interscalene brachial plexus block | Procedure or surgery | Group A |
| clonidine 1 mg / kgclonidine 1 mg / kg | Drug | Group A, Group B |
| single shot US-guided suprascapular nerve blocksingle shot US-guided suprascapular nerve block | Procedure or surgery | Group B |
Primary outcome
postoperative pain score
Time frame: 24 hours postoperative
to evaluate postoperative pain score during arthroscopic shoulder surgery assessed by the pain score when comparing the combined suprascapular and costoclavicular nerve blocks to the interscalene brachial plexus block
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Bupivacaine 0.5% (hyperbaric), US-guided costoclavicular block and Interscalene brachial plexus block in people with Arthroscopic Shoulder Surgeries, run by Assiut University.
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 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: opening soon, as of the sponsor's last update on 1 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
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 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?
This study is still under way. Results are not available in the source record yet.
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 pain score (time frame: 24 hours postoperative). 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 Dec 2025; AzTrials last refreshed its copy on 8 Nov 2026.