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
Overview
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Assiut University
- Enrollment
- 54
- Primary Endpoint
- Total Postoperative Opioid Consumption (mg of morphine equivalents)
Overview
Brief Summary
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
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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.
Arms & Interventions
Dexmedetomidine + Bupivacaine
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.
Intervention: Dexmedetomidine (Drug)
Bupivicaine
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.
Intervention: Dexmedetomidine (Drug)
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Postoperative Pain Intensity Using the Visual Analog Scale (VAS 0-10)(2, 4, 6, 12, 18, and 24 hours postoperative.)
- Time to First Request for Rescue Analgesia.(24 hour postoperative)
- Number of Participants with Adverse Effects(first 2 hours postoperative.)
- patient satisfaction score(1 hour postoperative)
- Block-related complications.(intraoperative and 24 postoperative)
Investigators
Mohamed Ibrahem Shaker
Anesthesia Resident
Assiut University