Brachial Plexus BlocksPhase 4NCT07299877
Perineural Dexamethasone, Dexmedetomidine, or Their Combination to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block
A Phase 4 study testing Group A (Dexamethasone), Group B (Dexmedetomidine) and Group C (Dexamethasone + Dexmedetomidine) in people with Brachial Plexus Blocks, run by Al-Azhar University at 1 site in Egypt.
Trial summary
Dexmedetomidine, an α2 adrenoceptor agonist, and dexamethasone, a potent anti-inflammatory steroid, are commonly used, effective, and safe adjuvants to peripheral nerve block (PNB). Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Brachial Plexus Blocks
- What is being tested?
- Group A (Dexamethasone), Group B (Dexmedetomidine) and Group C (Dexamethasone + Dexmedetomidine)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteEgypt
- Study dates
- 28 Dec 2025to 15 Oct 2026
- 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 20 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- from 20-65 years old
- and ASA physical status I or II and III,
- and of either gender,
- who provided informed, written, and valid consent,
- were scheduled for elective orthopedic upper limb surgeries for traumatic fractures under Supraclavicular Brachial Plexus Block.
Who cannot join
- Patients with coagulopathies,
- neurological disorders,
- hypersensitivity to any of the study drugs, or
- a history of previous surgeries on the affected limb
- and those who refused to sign informed consent
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
Benha University, Faculty of Medicine
Banhā, Qalyubiyya, 300001
Neveen A. Kohaf, PhD, 01060383012, nevenabdo@azhar.edu.eg
Hany Baumy, M.D
About this study
Official title: Perineural Dexamethasone, Dexmedetomidine or Their Combination: an Effort to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block: A Triple-Blind Randomized Controlled Trial
Dexmedetomidine, an α2 adrenoceptor agonist, and dexamethasone, a potent anti-inflammatory steroid, are commonly used, effective, and safe adjuvants to peripheral nerve block (PNB). Both have been found to delay and reduce the incidence of rebound pain (RP), prolong the duration of sensory and motor block, and enhance analgesia without causing significant respiratory depression. Few studies have explored the effectiveness of dexmedetomidine or dexamethasone as sole adjuvants to PNB for preventing or reducing RP. However, no study has directly compared the effectiveness of these two drugs in reducing RP when used as adjuvants to local anesthetic (LA) in PNB. Due to differences in their mechanism of action, their effects on RP may differ significantly. The investigators hypothesized that the combination of dexamethasone and dexmedetomidine reduces the incidence of RP when used as adjuvants to LA in PNB.
- Conditions
- Brachial Plexus Blocks
- Being tested
- Group A (Dexamethasone), Group B (Dexmedetomidine), Group C (Dexamethasone + Dexmedetomidine)
- Keywords
- Dexamethasone, dexmedetomidine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group A (Dexamethasone)Drug
8 mg of dexamethasone will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
Group B (Dexmedetomidine)Drug
1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
Group C (Dexamethasone + Dexmedetomidine)Drug
8 mg of dexamethasone + 1 microgram/kg dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine.
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 8 mg of dexamethasone will be added to the local anesthetic.The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. Receives: Drug: Group A (Dexamethasone) |
| Group B | Active comparator | 1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. Receives: Drug: Group B (Dexmedetomidine) |
| Group C | Active comparator | 8 mg of dexamethasone + 1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. Receives: Drug: Group C (Dexamethasone + Dexmedetomidine) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of rebound pain after the end of anesthesia
The incidence of rebound pain after the end of anaesthesia will be measured. Rebound pain refers to a transient, intense increase in pain that occurs after the resolution of a peripheral nerve block. It represents the patient's perception of a sudden change from numbness to severe pain once the block wears off - often within the first 24 hours postoperatively. The Visual Analogue Scale (VAS) will be used to measure pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
Measured: 24 hours
Secondary outcomes (8)
Onset of Rebound Pain
The onset of rebound pain is the time interval between the resolution of the peripheral nerve block and the patient's first report of significant pain. The Visual Analogue Scale (VAS) will be used to measure a patient's subjective pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
Measured: 24 hours
Duration of Rebound Pain
The duration of rebound pain refers to the length of time the heightened pain persists after its onset until it returns to a baseline or tolerable level with analgesic management.
Measured: 24 hours
Severity of Rebound Pain
The severity of rebound pain is the intensity of pain experienced after block resolution, typically measured using the Visual Analogue Scale (VAS). The Visual Analogue Scale (VAS) will be used to measure a patient's subjective pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
Measured: 24 hours
Time to first analgesic request
The time to first request for analgeseia will be measured
Measured: 24 hours
Incidence of sleep disturbances due to surgical site pain
Sleep disturbance due to surgical site pain refers to difficulty initiating or maintaining sleep, or poor sleep quality, directly attributed to postoperative pain from the surgical site during the recovery period (usually within the first few nights after surgery).
Assessment Method Direct Patient Questioning
A structured interview asking:
"Did pain at your surgical site interfere with your sleep last night?" "How many times did you wake up because of pain?" "How would you rate your sleep quality (excellent, good, fair, poor)?" A "yes" or poor sleep rating indicates sleep disturbance.
Measured: 48 hours
Pain score
The Visual Analogue Scale (VAS) will be used to measure a patient's subjective pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
Measured: 24 hours
Consumption of fentanyl
the amount of of fentanyl rescue analgesia within the first 48 hours after surgery will be documented.
Measured: 48 hours
Patient satisfaction.
Simple, structured questions will be used postoperatively:
"How satisfied are you with your anaesthesia care?" "Were you comfortable during and after surgery?"
Responses are rated on a Likert scale, such as:
1 = very dissatisfied, 2 = dissatisfied, 3 = neutral, 4 = satisfied, and 5 = very satisfied.
This allows calculation of the percentage of satisfied patients (scores 4-5).
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 posted23 Dec 2025
- Study start28 Dec 2025 (estimated)
- Primary completion15 Oct 2026 (estimated)
- Study completion15 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Brachial Plexus BlocksStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Collaborators
- Benha University
- Responsible party
- Principal investigator, Neveen Abd El Maksoad Kohaf, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07299877
- Sponsor's protocol ID
- RC. 10.9.2025
- Status last verified
- Oct 2025
- First submitted
- 10 Dec 2025
- Last updated
- 9 Jan 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data could be shared with a reasonable request from corresponding author
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perineural Dexamethasone, Dexmedetomidine or Their Combination: an Effort to Reduces Rebound Pain After Supraclavicular Brachial Plexus Block: A Triple-Blind Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07299877
- Acronym / sponsor ID
- RC. 10.9.2025
- Conditions
- Brachial Plexus Blocks
- Keywords
- Dexamethasone, dexmedetomidine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Collaborators
- Benha University
- Study start
- 28 Dec 2025 (estimated)
- Primary completion
- 15 Oct 2026 (estimated)
- Study completion
- 15 Oct 2026 (estimated)
- First posted
- 23 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.
Dexmedetomidine, an α2 adrenoceptor agonist, and dexamethasone, a potent anti-inflammatory steroid, are commonly used, effective, and safe adjuvants to peripheral nerve block (PNB). Both have been found to delay and reduce the incidence of rebound pain (RP), prolong the duration of sensory and motor block, and enhance analgesia without causing significant respiratory depression. Few studies have explored the effectiveness of dexmedetomidine or dexamethasone as sole adjuvants to PNB for preventing or reducing RP. However, no study has directly compared the effectiveness of these two drugs in reducing RP when used as adjuvants to local anesthetic (LA) in PNB. Due to differences in their mechanism of action, their effects on RP may differ significantly. The investigators hypothesized that the combination of dexamethasone and dexmedetomidine reduces the incidence of RP when used as adjuvants to LA in PNB.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Group A (Dexamethasone)8 mg of dexamethasone will be added to the local anesthetic.The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. |
| Group B | Active comparator | Drug: Group B (Dexmedetomidine)1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. |
| Group C | Active comparator | Drug: Group C (Dexamethasone + Dexmedetomidine)8 mg of dexamethasone + 1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic that will be used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- from 20-65 years old
- and ASA physical status I or II and III,
- and of either gender,
- who provided informed, written, and valid consent,
- were scheduled for elective orthopedic upper limb surgeries for traumatic fractures under Supraclavicular Brachial Plexus Block.
Key exclusion criteria (5 listed)
- Patients with coagulopathies,
- neurological disorders,
- hypersensitivity to any of the study drugs, or
- a history of previous surgeries on the affected limb
- and those who refused to sign informed consent
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 |
|---|---|---|
| Group A (Dexamethasone)8 mg of dexamethasone will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. | Drug | Group A |
| Group B (Dexmedetomidine)1 microgram/kg of dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. | Drug | Group B |
| Group C (Dexamethasone + Dexmedetomidine)8 mg of dexamethasone + 1 microgram/kg dexmedetomidine will be added to the local anesthetic. The local anesthetic used in all cases was a mixture of 10 ml of 2% xylocaine and 10 ml of 0.5% bupivacaine. | Drug | Group C |
Primary outcome
The incidence of rebound pain after the end of anesthesia
Time frame: 24 hours
The incidence of rebound pain after the end of anaesthesia will be measured. Rebound pain refers to a transient, intense increase in pain that occurs after the resolution of a peripheral nerve block. It represents the patient's perception of a sudden change from numbness to severe pain once the block wears off - often within the first 24 hours postoperatively. The Visual Analogue Scale (VAS) will be used to measure pain intensity. It consists of a 10-centimetre horizontal line, with the left end labelled "no pain" (0) and the right end labelled "worst imaginable pain" (10).
8 secondary outcomes
Onset of Rebound Pain
Time frame: 24 hours
Duration of Rebound Pain
Time frame: 24 hours
Severity of Rebound Pain
Time frame: 24 hours
Time to first analgesic request
Time frame: 24 hours
Incidence of sleep disturbances due to surgical site pain
Time frame: 48 hours
Pain score
Time frame: 24 hours
Consumption of fentanyl
Time frame: 48 hours
Patient satisfaction.
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 9 Jan 2026.
- Individual participant dataSharing planned: Yes. Data could be shared with a reasonable request from corresponding author
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Group A (Dexamethasone), Group B (Dexmedetomidine) and Group C (Dexamethasone + Dexmedetomidine) in people with Brachial Plexus Blocks, run by Al-Azhar 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: opening soon, as of the sponsor's last update on 9 Jan 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 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?
Contact Neveen A Kohaf, Ph.D (+201060383012, nevenabdo@azhar.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of rebound pain after the end of anesthesia (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 9 Jan 2026.