Analgesia, PostoperativePhase 1NCT06658418
Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries
A Phase 1 study testing Erector Spinae Plane Block in people with Analgesia, Postoperative, run by Loay Gamal.
Trial summary
To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia, Postoperative
- What is being tested?
- Erector Spinae Plane Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2024to 1 Dec 2026
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age :18 years old and older. Patients undergoing open abdominal surgery.
Who cannot join
- Patient refusal
- known sensitivity or contraindication to any of study drugs
- contraindications for local anesthesia
- Patients with local infection at site of puncture
- uncooperative patients
- history of psychological disorders or chronic pain and significant liver or renal disease.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries
- Conditions
- Analgesia, Postoperative
- Being tested
- Erector Spinae Plane Block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erector Spinae Plane BlockProcedure or surgery
dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries.
| Study group | Role | What they receive |
|---|---|---|
| dexmedetomidine combined with bupivacaine | Active comparator | use for Dexmedetomidine and bupivacain for erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
| dexamethasone combined with bupivacaine | Experimental | use of dexamethasone combined with bupivacaine for erector spinae plane block Receives: Procedure: Erector Spinae Plane Block |
What is being measured
The primary outcome is the main question the study is designed to answer.
VAS score
pain intensity using VAS score
Measured: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
Secondary outcomes (1)
the time for requirement of first morphine dose
the time for requirement of first morphine dose (hours)
Measured: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2024
- Study start1 Nov 2024 (estimated)
- Primary completion1 Nov 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.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Analgesia, PostoperativeStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Loay Gamal
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Loay Gamal, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06658418
- Sponsor's protocol ID
- erector spinae plane block
- Status last verified
- Oct 2024
- First submitted
- 24 Oct 2024
- Last updated
- 26 Oct 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
PubMed 20418538
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block with Dexmedetomidine and Bupivacain Versus Dexamethasone and Bupivacain for Postoperative Analgesia in Patients Undergoing Abdominal Surgeries
- ClinicalTrials.gov ID
- NCT06658418
- Acronym / sponsor ID
- erector spinae plane block
- Conditions
- Analgesia, Postoperative
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Loay GamalUniversity, hospital or other
- Study start
- 1 Nov 2024 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 26 Oct 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.
To compare the analgesic effect of dexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dexmedetomidine combined with bupivacaine | Active comparator | Procedure: Erector Spinae Plane Blockuse for Dexmedetomidine and bupivacain for erector spinae plane block |
| dexamethasone combined with bupivacaine | Experimental | Procedure: Erector Spinae Plane Blockuse of dexamethasone combined with bupivacaine for erector spinae plane block |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Age :18 years old and older. Patients undergoing open abdominal surgery.
Key exclusion criteria (6 listed)
- Patient refusal
- known sensitivity or contraindication to any of study drugs
- contraindications for local anesthesia
- Patients with local infection at site of puncture
- uncooperative patients
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 |
|---|---|---|
| Erector Spinae Plane Blockdexmedetomidine combined with bupivacaine versus dexamethasone combined with bupivacaine for ultrasound-guided ESPB for postoperative pain control in patients scheduled for abdominal surgeries. | Procedure or surgery | dexamethasone combined with bupivacaine, dexmedetomidine combined with bupivacaine |
Primary outcome
VAS score
Time frame: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
pain intensity using VAS score
1 secondary outcome
the time for requirement of first morphine dose
Time frame: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.
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 26 Oct 2024.
- Background: PubMed 20418538Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Erector Spinae Plane Block in people with Analgesia, Postoperative, run by Loay Gamal.
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: opening soon, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 loay GAMAL loay Gamal, master (+201017675686, loaygamal94@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
VAS score (time frame: at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperative.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06658418, which also lists 1 linked publication.
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 26 Oct 2024.