Pain ManagementNCT06406712
Retroclavicular Block in Vascular Surgey
A study testing retroclavicular block in people with Pain Management, run by New Valley University at 1 site in Egypt.
Trial summary
The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform . The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Pain Management
- What is being tested?
- retroclavicular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2024to 1 Dec 2026
- Phase
- Interventional
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing upper limb vascular surgey .
Who cannot join
- - Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
- Altered conscious level.
- Pregnancy.
- Body mass index (BMI > 35).
- Patients who have difficulty understanding the study protocol.
- Patients who have any known contraindication to study medications.
- Patient refusal.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site, 1 recruiting
- Recruiting
Faculty of Medicine
Asyut
hassan abdel lataif, prof
About this study
Official title: Efficacy of Retroclavicular Dexamethasone With Bupivacaine in Patients Undergoing Upper Limb Vascular Surgeries
The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform .
The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.
Read the detailed description
Regional anesthesia (RA) offers several advantages over general anesthesia (GA) for upper limb orthopedic surgery. One of the advantages is the improvement in postoperative pain, which leads to decreased use of postoperative opioids needs and reduces the recovery time for patients . A variety of approaches for regional blockade for upper extremity surgery have been described.
Dexamethasone is a corticosteroid drug that has been used as an adjuvant to reduce postoperative pain.
The use of peri neural dexamethasone (i.e. dexamethasone added to the local anesthesia solution) as an adjuvant to peripheral nerve block to improve analgesia provided by local anesthetic alone . Peri neural dexamethasone, as an adjuvant to peripheral nerve block, has been associated with faster onset of anesthesia , longer duration of anesthesia/analgesia decreased postoperative pain intensity and decreased postoperative analgesia requirements compared with local anaesthetic alone . The exact mechanism by which dexamethasone reduces pain is not known. The decrease in pain intensity and the prolonged analgesia attained with the use of perineural dexamethasone may be the result of a local, or systemic action, or both . Dexamethasone may act locally on glucocorticosteroid receptors to induce vasoconstriction, thereby decreasing systemic absorption of local anaesthetics . Other potential mechanisms of action include suppression of C-fibre transmission of pain signals and direct action on the nerve cell to reduce neural discharge . Dexamethasone may act systemically by reducing the inflammatory response caused by surgical tissue injury .
- Conditions
- Pain Management
- Being tested
- retroclavicular block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retroclavicular blockOther
regional anesthesia
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone with bupivacaine in retroclavicular block | Active comparator | 40patients received 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml of dexamethasone) Receives: Other: retroclavicular block |
| bupivacaine in retroclavicular block (control group) | Active comparator | : 40patients received. 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml saline Receives: Other: retroclavicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
sensory and motor duration of block
efficacy of block
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 posted9 May 2024
- Study start1 Jun 2024
- Primary completion1 Jun 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- New Valley University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmed Ismail Abdelsabour, New Valley University
- Investigators
- ahmed ismail, lecture, Principal investigator, faculty of medicine , new valley university
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406712
- Sponsor's protocol ID
- new valley anesthesia g2
- Status last verified
- May 2026
- First submitted
- 6 May 2024
- Last updated
- 7 May 2026
- 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 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Retroclavicular Dexamethasone With Bupivacaine in Patients Undergoing Upper Limb Vascular Surgeries
- ClinicalTrials.gov ID
- NCT06406712
- Acronym / sponsor ID
- new valley anesthesia g2
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Jun 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 9 May 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.
The retroclavicular (coracoid) approach for brachial plexus anesthesia is recognized for its facility and simplicity to perform .
The block has been well described in the anesthesia community since it was first introduced by Hebbard and Royse in 2007 . In 2017, Luftig . first described the block's use in the ED setting for a variety of indications . Because of its different needle entry point, the retro clavicular (RCB) approach offers an almost perpendicular needle-ultrasound (US) beam angle.
Detailed description
Regional anesthesia (RA) offers several advantages over general anesthesia (GA) for upper limb orthopedic surgery. One of the advantages is the improvement in postoperative pain, which leads to decreased use of postoperative opioids needs and reduces the recovery time for patients . A variety of approaches for regional blockade for upper extremity surgery have been described.
Dexamethasone is a corticosteroid drug that has been used as an adjuvant to reduce postoperative pain.
The use of peri neural dexamethasone (i.e. dexamethasone added to the local anesthesia solution) as an adjuvant to peripheral nerve block to improve analgesia provided by local anesthetic alone . Peri neural dexamethasone, as an adjuvant to peripheral nerve block, has been associated with faster onset of anesthesia , longer duration of anesthesia/analgesia decreased postoperative pain intensity and decreased postoperative analgesia requirements compared with local anaesthetic alone . The exact mechanism by which dexamethasone reduces pain is not known. The decrease in pain intensity and the prolonged analgesia attained with the use of perineural dexamethasone may be the result of a local, or systemic action, or both . Dexamethasone may act locally on glucocorticosteroid receptors to induce vasoconstriction, thereby decreasing systemic absorption of local anaesthetics . Other potential mechanisms of action include suppression of C-fibre transmission of pain signals and direct action on the nerve cell to reduce neural discharge . Dexamethasone may act systemically by reducing the inflammatory response caused by surgical tissue injury .
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone with bupivacaine in retroclavicular block | Active comparator | Other: retroclavicular block40patients received 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml of dexamethasone) |
| bupivacaine in retroclavicular block (control group) | Active comparator | Other: retroclavicular block: 40patients received. 40 ml of bupivacaine 0.25%(in total 100 mg)+1 ml saline |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing upper limb vascular surgey .
Key exclusion criteria (7 listed)
- - Contraindications to regional block (coagulopathy, infection at the needle insertion site, or diaphragmatic paralysis).
- Altered conscious level.
- Pregnancy.
- Body mass index (BMI > 35).
- Patients who have difficulty understanding the study protocol.
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 |
|---|---|---|
| retroclavicular blockregional anesthesia | Other | bupivacaine in retroclavicular block (control group), dexamethasone with bupivacaine in retroclavicular block |
Primary outcome
sensory and motor duration of block
Time frame: 24 hours
efficacy of 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 7 May 2026.
- 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.
ahmed ismail, lecture principal investigator
faculty of medicine , new valley 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 retroclavicular block in people with Pain Management, run by New Valley 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 7 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: looking for participants now, as of the sponsor's last update on 7 May 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.
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?
Contact ahmed ismail, lecture (01097845491, ahmed_ismail87@med.nvu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
sensory and motor duration of 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 7 May 2026.