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

November 23, 2025 updated by: Mohamed Ibrahem Shaker, Assiut University

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

54

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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.
Drug: Dexmedetomidine
Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block
Active Comparator: 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.
Drug: Dexmedetomidine
Dexmedetomidine as Adjuvant toBupivacaine in Ultrasound Guided ExternalOblique Intercostal Plane Block

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
24 hours postoperative.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Assiut University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

December 15, 2025

Primary Completion (Estimated)

February 15, 2026

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

November 16, 2025

First Submitted That Met QC Criteria

November 23, 2025

First Posted (Estimated)

December 4, 2025

Study Record Updates

Last Update Posted (Estimated)

December 4, 2025

Last Update Submitted That Met QC Criteria

November 23, 2025

Last Verified

October 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • External Ob. intercostal block

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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