Pain ManagementNCT06406647
Rectroclavicular Block in Orthopedic Surgey
A study testing retrocalvicular block in people with Pain Management, run by New Valley University at 1 site in Egypt.
Trial summary
The ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. 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?
- retrocalvicular block
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Apr 2026to 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 orthopedic surgery,
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 lataf, prof
About this study
Official title: Adding Ketamine as Adjuvant in Retroclavicular Block in Upper Limb Orthopedic Surgey
The ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. 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 . This nerve block has classically been described to provide extensive anesthesia for procedures distal to the shoulder, such as elbow dislocations, distal radius fractures, and surgical procedures.
Read the detailed description
Ultrasound-guided regional anesthesia of the infraclavicular brachial plexus offers dense anesthesia of the distal upper extremity. The Retro clavicular Approach to The Infraclavicular Region (RAPTIR) is an ultrasound-guided brachial plexus block that has only recently been described in both anesthesia and emergency literature.
Ketamine is a dissociative anesthetic used medically for induction and maintenance of anesthesia. It is also used as a treatment for depression, a pain management tool, and as a recreational drug . Ketamine is a novel compound that was derived from phencyclidine in 1962 in pursuit of a safer anesthetic with fewer hallucinogenic effects .
At anesthetic doses, ketamine induces a state of dissociative anesthesia, a trance-like state providing pain relief, sedation, and amnesia . The distinguishing features of ketamine as anesthesia are preserved breathing and airway reflexes, stimulated heart function with increased blood pressure, and moderate bronchodilation At lower, sub-anesthetic doses, ketamine is a promising agent for pain and treatment-resistant depression. As with many antidepressants, the results of a single administration of ketamine wane with time. The long-term effects of repeated use are largely unknown, and are an area of active investigation.
Liver and urinary toxicity have been reported among regular users of high doses of ketamine for recreational purposes. Ketamine is an NMDA receptor pore blocker, accounting for most of its actions, but not the antidepressant effect, the mechanism of which is a matter of research and debate.
Ketamine was first synthesized in 1962 and approved for use in the United States in 1970. It has been regularly used in veterinary medicine and was extensively used for surgical anesthesia in the Vietnam War. Along with other psychotropic drugs, it is on the World Health Organization's List of Essential Medicines. It is available as a generic medication. When used as a recreational drug, it is found both in powder and liquid form, and is often referred to as "Special K" for its hallucinogenic and dissociative effects.
- Conditions
- Pain Management
- Being tested
- retrocalvicular block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retrocalvicular blockOther
retrocalvicular block in upper limb orthopedic Surgey
| Study group | Role | What they receive |
|---|---|---|
| ketamine with bupicavaine | Active comparator | (bupivacaine+ ketamine): 40patients received 40 ml of bupivacaine 0.25%(in total 100mg)+1mg per Kg of ketamine) Receives: Other: retrocalvicular block |
| bupicavacine (control group) | Active comparator | (Bupivacaine): 40patients received40 ml of bupivacaine 0.25%(in total 100 mg)+2 ml saline. Receives: Other: retrocalvicular block |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating pain scale .
0= no pain , 10 = sever pain
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 Apr 2026
- Primary completion1 Dec 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, New Valley University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06406647
- Sponsor's protocol ID
- Newvalley anesthesia
- 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
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
- Adding Ketamine as Adjuvant in Retroclavicular Block in Upper Limb Orthopedic Surgey
- ClinicalTrials.gov ID
- NCT06406647
- Acronym / sponsor ID
- Newvalley anesthesia
- Conditions
- Pain Management
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 1 Dec 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 ultrasound-guided retroclavicular approach to the infraclavicular region (RAPTIR) brachial plexus block has gained popularity as a relatively easy-to-perform nerve block that provides reliable and dense anesthesia to the upper extremity with a single injection. 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 . This nerve block has classically been described to provide extensive anesthesia for procedures distal to the shoulder, such as elbow dislocations, distal radius fractures, and surgical procedures.
Detailed description
Ultrasound-guided regional anesthesia of the infraclavicular brachial plexus offers dense anesthesia of the distal upper extremity. The Retro clavicular Approach to The Infraclavicular Region (RAPTIR) is an ultrasound-guided brachial plexus block that has only recently been described in both anesthesia and emergency literature.
Ketamine is a dissociative anesthetic used medically for induction and maintenance of anesthesia. It is also used as a treatment for depression, a pain management tool, and as a recreational drug . Ketamine is a novel compound that was derived from phencyclidine in 1962 in pursuit of a safer anesthetic with fewer hallucinogenic effects .
At anesthetic doses, ketamine induces a state of dissociative anesthesia, a trance-like state providing pain relief, sedation, and amnesia . The distinguishing features of ketamine as anesthesia are preserved breathing and airway reflexes, stimulated heart function with increased blood pressure, and moderate bronchodilation At lower, sub-anesthetic doses, ketamine is a promising agent for pain and treatment-resistant depression. As with many antidepressants, the results of a single administration of ketamine wane with time. The long-term effects of repeated use are largely unknown, and are an area of active investigation.
Liver and urinary toxicity have been reported among regular users of high doses of ketamine for recreational purposes. Ketamine is an NMDA receptor pore blocker, accounting for most of its actions, but not the antidepressant effect, the mechanism of which is a matter of research and debate.
Ketamine was first synthesized in 1962 and approved for use in the United States in 1970. It has been regularly used in veterinary medicine and was extensively used for surgical anesthesia in the Vietnam War. Along with other psychotropic drugs, it is on the World Health Organization's List of Essential Medicines. It is available as a generic medication. When used as a recreational drug, it is found both in powder and liquid form, and is often referred to as "Special K" for its hallucinogenic and dissociative effects.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ketamine with bupicavaine | Active comparator | Other: retrocalvicular block(bupivacaine+ ketamine): 40patients received 40 ml of bupivacaine 0.25%(in total 100mg)+1mg per Kg of ketamine) |
| bupicavacine (control group) | Active comparator | Other: retrocalvicular block(Bupivacaine): 40patients received40 ml of bupivacaine 0.25%(in total 100 mg)+2 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 orthopedic surgery,
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 |
|---|---|---|
| retrocalvicular blockretrocalvicular block in upper limb orthopedic Surgey | Other | bupicavacine (control group), ketamine with bupicavaine |
Primary outcome
numerical rating pain scale .
Time frame: 24 hours
0= no pain , 10 = sever pain
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.
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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
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 retrocalvicular 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?
numerical rating pain scale . (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.