Pain ManagementPhase 2/3AnyNCT05705128
Dexmedetomidine in Postoperative Analgesia
A Phase 2/3 study testing Dexmedetomidine in people with Pain Management, run by New Valley University at 1 site in Egypt.
Trial summary
There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Pain Management
- What is being tested?
- Dexmedetomidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2023to 20 May 2026
- Phase
- Phase 2/3
- 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
- Patients undergoing elective shoulder arthroscopy under general anesthesia
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.
About this study
Official title: Comparison Between Effect of Addition of Dexamethasone and Dexmedetomidine in Combination With Bupivacaine for Pain Relief After Shoulder Arthroscopic Surgeries
There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic requirements to improve rapid recovery and reduce postoperative pain.
Read the detailed description
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to ISB.most of the nerve supply from C5 and C6 nerve roots are carried by suprascapular and the axillary nerves. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder.
Dexamethasone is a glucocorticoid that is commonly used to decrease the body's inflammatory response. Doses of 1, 2, 4, and 8 mg have been used as an adjuvant in interscalene, supraclavicular, ankle, and brachial plexus blocks . However, when dexamethasone is used as an adjuvant in a PNB, the specific mechanism of action is unknown . Dexamethasone may produce extended analgesia through vasoconstriction and reduced absorption of local anesthetic or through "direct action on the nerve cell to reduce neural discharge" .
Despite having an unknown mechanism, a Cochrane review of 35 trials of 2702 participants determined that perineural dexamethasone adjuvant increased sensory block 6.7 hours (95% confidence interval) in comparison to a placebo . Similarly, intravenous dexamethasone increased sensory block 6.2 hours in comparison Dexmedetomidine is a highly selective and potent central alpha-2 adrenergic receptor agonist. Administration of this adjuvant in miscellaneous methods has received considerable attention in recent years. Due to its analgesic and sedative effects, besides the lack of any respiratory-sparing effects, administration of this adjuvant has been effective in reducing the need for opioids in the perioperative period and may even result in cooperative sedation . Given the sympatholytic effects of dexmedetomidine (hypotension and bradycardia), in addition to oversedation, especially when administered intravenously or at high doses, caution must be taken in administering this drug, especially in elderly patients.
The neuraxial administration of dexmedetomidine has nociceptive effects on somatic and visceral pains . It also reduces postoperative pain and prolongs analgesia, although there is a risk of bradycardia. Various doses of dexmedetomidine, along with a number of analgesic drugs, have been used in many studies. However, the exact dose of dexmedetomidine, as an adjuvant drug administered along with other intravenous drugs in the perioperative period, has been controversial.
The proposed mechanism for perineural dexmedetomidine in PNBs as first studied in rat models is similar to that of clonidine, which relies not on alpha-2 agonism mechanism, but instead blocks hyperpolarization-activated Ih cation currents and causes vasoconstriction for prolonged analgesia . Perineural dexmedetomidine adjunct use is off-label, and proper risk-benefit analysis, especially in patients where bradycardia and hypotension would be concerning, would be necessary before even more widespread use of dexmedetomidine in PNBs can be expected .
- Conditions
- Pain Management
- Being tested
- Dexmedetomidine
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine will be given with bupivaciane for postoperative pain control
| Study group | Role | What they receive |
|---|---|---|
| dexamethasone group | Active comparator | patients will receive dexamethasone with bupivacaine before general anaesthesia Receives: Drug: Dexmedetomidine |
| dexmedetomidine group | Active comparator | patients will receive dexemedetomidine with bupivacaine before general anaesthesia Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
numerical rating pain scale
graded from 0 to 10 (0 = no pain, 10 = the worst possible pain)
Measured: 24 hours
Secondary outcomes (1)
complications
postoperative complications
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 posted30 Jan 2023
- Study start1 Aug 2023
- Primary completion15 May 2025
- Study completion20 May 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 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 abdelsabour, lecturer, Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05705128
- Sponsor's protocol ID
- Assiut anesthesia g35
- Acronym
- Any
- Status last verified
- May 2026
- First submitted
- 21 Jan 2023
- 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
- Comparison Between Effect of Addition of Dexamethasone and Dexmedetomidine in Combination With Bupivacaine for Pain Relief After Shoulder Arthroscopic Surgeries
- ClinicalTrials.gov ID
- NCT05705128
- Acronym / sponsor ID
- Any / Assiut anesthesia g35
- Conditions
- Pain Management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- New Valley UniversityUniversity, hospital or other
- Study start
- 1 Aug 2023 (actual)
- Primary completion
- 15 May 2025 (actual)
- Study completion
- 20 May 2026 (estimated)
- First posted
- 30 Jan 2023 (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.
There is a high incidence reaching up to 45%; of severe intraoperative and postoperative pain associated with arthroscopic shoulder surgery, which is often significant enough to interfere with initial recovery and rehabilitation.Various peripheral nerve blocks have been used to reduce intraoperative anesthetic requirements to improve rapid recovery and reduce postoperative pain.
Detailed description
Recently, the Combined suprascapular nerve block and axillary nerve block (SSNB+ANB) was proposed to provide anesthesia and postoperative analgesia for shoulder surgery as a safe alternative to ISB.most of the nerve supply from C5 and C6 nerve roots are carried by suprascapular and the axillary nerves. These two peripheral nerves are responsible for the majority of the sensory innervation of the shoulder.
Dexamethasone is a glucocorticoid that is commonly used to decrease the body's inflammatory response. Doses of 1, 2, 4, and 8 mg have been used as an adjuvant in interscalene, supraclavicular, ankle, and brachial plexus blocks . However, when dexamethasone is used as an adjuvant in a PNB, the specific mechanism of action is unknown . Dexamethasone may produce extended analgesia through vasoconstriction and reduced absorption of local anesthetic or through "direct action on the nerve cell to reduce neural discharge" .
Despite having an unknown mechanism, a Cochrane review of 35 trials of 2702 participants determined that perineural dexamethasone adjuvant increased sensory block 6.7 hours (95% confidence interval) in comparison to a placebo . Similarly, intravenous dexamethasone increased sensory block 6.2 hours in comparison Dexmedetomidine is a highly selective and potent central alpha-2 adrenergic receptor agonist. Administration of this adjuvant in miscellaneous methods has received considerable attention in recent years. Due to its analgesic and sedative effects, besides the lack of any respiratory-sparing effects, administration of this adjuvant has been effective in reducing the need for opioids in the perioperative period and may even result in cooperative sedation . Given the sympatholytic effects of dexmedetomidine (hypotension and bradycardia), in addition to oversedation, especially when administered intravenously or at high doses, caution must be taken in administering this drug, especially in elderly patients.
The neuraxial administration of dexmedetomidine has nociceptive effects on somatic and visceral pains . It also reduces postoperative pain and prolongs analgesia, although there is a risk of bradycardia. Various doses of dexmedetomidine, along with a number of analgesic drugs, have been used in many studies. However, the exact dose of dexmedetomidine, as an adjuvant drug administered along with other intravenous drugs in the perioperative period, has been controversial.
The proposed mechanism for perineural dexmedetomidine in PNBs as first studied in rat models is similar to that of clonidine, which relies not on alpha-2 agonism mechanism, but instead blocks hyperpolarization-activated Ih cation currents and causes vasoconstriction for prolonged analgesia . Perineural dexmedetomidine adjunct use is off-label, and proper risk-benefit analysis, especially in patients where bradycardia and hypotension would be concerning, would be necessary before even more widespread use of dexmedetomidine in PNBs can be expected .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexamethasone group | Active comparator | Drug: Dexmedetomidinepatients will receive dexamethasone with bupivacaine before general anaesthesia |
| dexmedetomidine group | Active comparator | Drug: Dexmedetomidinepatients will receive dexemedetomidine with bupivacaine before general anaesthesia |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Patients undergoing elective shoulder arthroscopy under general anesthesia
Key exclusion criteria (6 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
- Patients who have any known contraindication to study medications
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 |
|---|---|---|
| DexmedetomidineDexmedetomidine will be given with bupivaciane for postoperative pain control | Drug | dexamethasone group, dexmedetomidine group |
Primary outcome
numerical rating pain scale
Time frame: 24 hours
graded from 0 to 10 (0 = no pain, 10 = the worst possible pain)
1 secondary outcome
complications
Time frame: 24 hours
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 abdelsabour, lecturer principal investigator
Assiut University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dexmedetomidine 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 6 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: enrolling by invitation, 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
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.