Dexmedetomidine as an Adjuvant to Bupivacaine for Ultrasound-Guided External Oblique Intercostal Block

NCT07263165 — Not applicable, Not yet recruiting, 54 participants, Assiut University

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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

Registry	NCT07263165, acronym Dexmedetomidin
Status	Not yet recruiting
Phase	Not applicable
Study type	Interventional; randomized, parallel, masking: quadruple, treatment
Enrollment	54 (Estimated)
Sponsor	Assiut University (Other)
Conditions	Opioid Consumption, Postoperative
Interventions	Dexmedetomidine (Drug)
Dates	start 2025-12-15 (estimated), primary completion 2026-02-15 (estimated), completion 2027-12-15 (estimated), first posted 2025-12-04, last updated 2025-12-04

-Summary

Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery.

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+Detailed description

Effect of Adding Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block in UpperAbdominal Cancer Surgery. A prospectiverandomized clinical trial

+Arms and interventions

Arm	Type	Interventions	Description
Dexmedetomidine + Bupivacaine	Experimental	Drug: Dexmedetomidine	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.
Bupivicaine	Active comparator	Drug: Dexmedetomidine	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.

Dexmedetomidine (Drug): Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block

+Outcome measures

Primary outcomes

Total Postoperative Opioid Consumption (mg of morphine equivalents) [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.

Secondary outcomes

Postoperative Pain Intensity Using the Visual Analog Scale (VAS 0-10) [2, 4, 6, 12, 18, and 24 hours postoperative.]: 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.
Time to First Request for Rescue Analgesia. [24 hour postoperative]: Time from block performance until first request for analgesia.
Number of Participants with Adverse Effects [first 2 hours postoperative.]: Incidence of nausea, vomiting, hypotension, and bradycardia.
patient satisfaction score [1 hour postoperative]: Patient satisfaction regarding pain control (0 = completely dissatisfied, 10 = fully satisfied). Higher scores indicate better satisfaction.
Block-related complications. [intraoperative and 24 postoperative]: Incidence of hematoma, infection, or local anesthetic systemic toxicity (LAST).

+Eligibility

Sex: All, ages: 18 Years to 70 Years

Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

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