Opioid Consumption, PostoperativeDexmedetomidinNCT07263165
Dexmedetomidine as an Adjuvant to Bupivacaine for Ultrasound-Guided External Oblique Intercostal Block
A study testing Dexmedetomidine in people with Opioid Consumption, Postoperative, run by Assiut University.
Trial summary
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Opioid Consumption, Postoperative
- What is being tested?
- Dexmedetomidine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- 15 Dec 2025to 15 Dec 2027
- 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 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients aged 18-70 years scheduled for elective upper abdominal cancer surgery (e.g., gastrectomy, hepatectomy, pancreatectomy).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) between 18-35 kg/m².
Who cannot join
- Patient refusal.
- Allergy to local anesthetics or dexmedetomidine.
- Coagulopathy (INR >1.5, platelet count <100,000/mm³).
- Infection at the injection site.
- Severe cardiopulmonary, renal, or hepatic dysfunction.
- Chronic opioid use (>30 mg morphine equivalents daily for >3 months).
- Pregnancy or lactation.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Moaaz M Tohamy contact
About this study
Official title: Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery. A Prospective Randomized Clinical Trial
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery.
Read the detailed description
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery. A prospectiverandomized clinical trial
- Conditions
- Opioid Consumption, Postoperative
- Being tested
- Dexmedetomidine
- Keywords
- dexmedetomidine, external oblique intercostal block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DexmedetomidineDrug
Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block
| Study group | Role | What they receive |
|---|---|---|
| Dexmedetomidine + Bupivacaine | Experimental | Participants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine combined with dexmedetomidine (0.5 µg/kg) administered as a single-shot injection. Receives: Drug: Dexmedetomidine |
| Bupivicaine | Active comparator | Participants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine administered as a single-shot injection without any adjuvant. Receives: Drug: Dexmedetomidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total Postoperative Opioid Consumption (mg of morphine equivalents)
To evaluate the effect of adding dexmedetomidine to bupivacaine on total opioid consumption within the first 24 hours after upper abdominal cancer surgery.
Measured: 24 hours postoperative.
Secondary outcomes (5)
Postoperative Pain Intensity Using the Visual Analog Scale (VAS 0-10)
Pain scores will be assessed at rest and during movement using the Visual Analog Scale (0 = no pain, 10 = worst pain). Higher scores indicate worse pain.
Measured: 2, 4, 6, 12, 18, and 24 hours postoperative.
Time to First Request for Rescue Analgesia.
Time from block performance until first request for analgesia.
Measured: 24 hour postoperative
Number of Participants with Adverse Effects
Incidence of nausea, vomiting, hypotension, and bradycardia.
Measured: first 2 hours postoperative.
patient satisfaction score
Patient satisfaction regarding pain control (0 = completely dissatisfied, 10 = fully satisfied). Higher scores indicate better satisfaction.
Measured: 1 hour postoperative
Block-related complications.
Incidence of hematoma, infection, or local anesthetic systemic toxicity (LAST).
Measured: intraoperative and 24 postoperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Dec 2025
- Study start15 Dec 2025 (estimated)
- Primary completion15 Feb 2026 (estimated)
- Study completion15 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Opioid Consumption, PostoperativeStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mohamed Ibrahem Shaker, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07263165
- Sponsor's protocol ID
- External Ob. intercostal block
- Acronym
- Dexmedetomidin
- Status last verified
- Oct 2025
- First submitted
- 16 Nov 2025
- Last updated
- 4 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Adding Dexmedetomidine as Adjuvant to Bupivacaine in Ultrasound Guided External Oblique Intercostal Plane Block in Upper Abdominal Cancer Surgery. A Prospective Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT07263165
- Acronym / sponsor ID
- Dexmedetomidin / External Ob. intercostal block
- Conditions
- Opioid Consumption, Postoperative
- Keywords
- dexmedetomidine, external oblique intercostal block
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 54 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Dec 2025 (estimated)
- Primary completion
- 15 Feb 2026 (estimated)
- Study completion
- 15 Dec 2027 (estimated)
- First posted
- 4 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.
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery.
Detailed description
Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery. A prospectiverandomized clinical trial
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dexmedetomidine + Bupivacaine | Experimental | Drug: DexmedetomidineParticipants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine combined with dexmedetomidine (0.5 µg/kg) administered as a single-shot injection. |
| Bupivicaine | Active comparator | Drug: DexmedetomidineParticipants will receive an ultrasound-guided external oblique intercostal plane block using 20 mL of 0.25% bupivacaine administered as a single-shot injection without any adjuvant. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients aged 18-70 years scheduled for elective upper abdominal cancer surgery (e.g., gastrectomy, hepatectomy, pancreatectomy).
- American Society of Anesthesiologists (ASA) physical status I-III.
- Body mass index (BMI) between 18-35 kg/m².
Key exclusion criteria (7 listed)
- Patient refusal.
- Allergy to local anesthetics or dexmedetomidine.
- Coagulopathy (INR >1.5, platelet count <100,000/mm³).
- Infection at the injection site.
- Severe cardiopulmonary, renal, or hepatic dysfunction.
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 as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block | Drug | Bupivicaine, Dexmedetomidine + Bupivacaine |
Primary outcome
Total Postoperative Opioid Consumption (mg of morphine equivalents)
Time frame: 24 hours postoperative.
To evaluate the effect of adding dexmedetomidine to bupivacaine on total opioid consumption within the first 24 hours after upper abdominal cancer surgery.
5 secondary outcomes
Postoperative Pain Intensity Using the Visual Analog Scale (VAS 0-10)
Time frame: 2, 4, 6, 12, 18, and 24 hours postoperative.
Time to First Request for Rescue Analgesia.
Time frame: 24 hour postoperative
Number of Participants with Adverse Effects
Time frame: first 2 hours postoperative.
patient satisfaction score
Time frame: 1 hour postoperative
Block-related complications.
Time frame: intraoperative and 24 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 4 Dec 2025.
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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.
Moaaz M Tohamy contact
Questions about this trial
What is this clinical trial studying?
A study testing Dexmedetomidine in people with Opioid Consumption, Postoperative, run by Assiut University.
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 3 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: opening soon, as of the sponsor's last update on 4 Dec 2025. 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.
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 Mohamed i Shaker (01012248619, aboiprahem1997@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total Postoperative Opioid Consumption (mg of morphine equivalents) (time frame: 24 hours postoperative.). 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 4 Dec 2025.