Pain ManagementPhase 2/3NCT06899841
Dexmedetomidine in Sonographic Guided Erector Spinae Plane Block
A Phase 2/3 study testing Dexmedetomidine in people with Pain Management, run by Assiut University at 1 site in Egypt.
Trial summary
to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries. Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Oct 2024to 1 Oct 2026
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age between 18 and 70 years.
- Both sexes, males and females.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Body mass index (BMI) of 18-35 kg/m2
- Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.
Who cannot join
- Patients under 18 years.
- Patient refusal of nerve block.
- Infection at the site of injection.
- Coagulopathy.
- Allergy to used medications.
- Psychiatric disorder or chronic pain syndromes.
- Chronic opioid use or substance abuse.
- Quadriplegic patients.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effect of Different Doses of Dexmedetomidine Added to Local Anesthetic in Sonographic Guided Erector Spinae Plane Block for Pain Management After Renal Surgeries : Randomized Clinical Trial
to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.
- 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
different doses of dexmedetomidine added to bupivacaine in erector spinae plane block
| Study group | Role | What they receive |
|---|---|---|
| low dose dex | Experimental | 0.5 mic/kg of dexmedetomidine administered Receives: Drug: Dexmedetomidine |
| intermediate dose dex | Experimental | 0.75 mic/kg of dexmedetomidine administered Receives: Drug: Dexmedetomidine |
| high dose dex | Experimental | 1 mic/kg of dexmedetomidine administered Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesic duration
postoperative analgesic duration with each dose
Measured: 24 hours
Secondary outcomes (3)
Pain score
severity of pain using visual analogue pain score
Measured: 24 hours
side effects
as hemodynamic effect as (hypotension, bradycardia), nausea and vomiting.
Measured: 24 hours
dynamic pain score
Dynamic visual analogue pain score (pain with cough, deep breath, and movement)
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 posted28 Mar 2025
- Study start1 Oct 2024
- Primary completion1 Sep 2026
- Study completion1 Oct 2026
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.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mahmoud Faisal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06899841
- Sponsor's protocol ID
- 04-2024-200943
- Status last verified
- Oct 2026
- First submitted
- 16 Mar 2025
- Last updated
- 30 Oct 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 30 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Different Doses of Dexmedetomidine Added to Local Anesthetic in Sonographic Guided Erector Spinae Plane Block for Pain Management After Renal Surgeries : Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT06899841
- Acronym / sponsor ID
- 04-2024-200943
- Conditions
- Pain Management
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 1 Sep 2026 (actual)
- Study completion
- 1 Oct 2026 (actual)
- First posted
- 28 Mar 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.
to investigate the postoperative analgesic effect of dexmedetomidine addition with different doses as an adjuvant to bupivacaine to Erector spinae plane block after renal surgeries.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| low dose dex | Experimental | Drug: Dexmedetomidine0.5 mic/kg of dexmedetomidine administered |
| intermediate dose dex | Experimental | Drug: Dexmedetomidine0.75 mic/kg of dexmedetomidine administered |
| high dose dex | Experimental | Drug: Dexmedetomidine1 mic/kg of dexmedetomidine administered |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age between 18 and 70 years.
- Both sexes, males and females.
- Patients with the American Society of Anesthesiologists (ASA) physical status I/II.
- Body mass index (BMI) of 18-35 kg/m2
- Patients scheduled for elective Renal or Percutaneous Nephrolithotomy.
Key exclusion criteria (8 listed)
- Patients under 18 years.
- Patient refusal of nerve block.
- Infection at the site of injection.
- Coagulopathy.
- Allergy to used 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 |
|---|---|---|
| Dexmedetomidinedifferent doses of dexmedetomidine added to bupivacaine in erector spinae plane block | Drug | high dose dex, intermediate dose dex, low dose dex |
Primary outcome
postoperative analgesic duration
Time frame: 24 hours
postoperative analgesic duration with each dose
3 secondary outcomes
Pain score
Time frame: 24 hours
side effects
Time frame: 24 hours
dynamic pain score
Time frame: 24 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Oct 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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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 Assiut 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 8 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: finished, as of the sponsor's last update on 30 Oct 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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 analgesic duration (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 30 Oct 2026.