Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain

Role of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Controlled Trial

This study aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.

Study Overview

• Status: Completed
• Conditions: Pain; Thoracotomy; Dexmedetomidine; Adjuvant; External Oblique Intercostal Plane Block
• Intervention / Treatment: Drug: Dexmedetomidine; Drug: Saline

Detailed Description

External oblique intercostal plane block (EOIPB) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status I-III.
• Scheduled for open thoracotomy.

Exclusion Criteria:

• Patients with neurological or intellectual disability.
• Infection at the injection site.
• Drug abuse.
• Allergic reaction to local anesthetics.
• Coagulation abnormalities.
• Pregnancy.
• Body Mass Index (BMI) ≥35 kg/m2.
• Severe cardiovascular problems.
• Diabetic neuropathy.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Dexmedetomidine group; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.	Drug: Dexmedetomidine; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.
Active Comparator: Control group; Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.	Drug: Saline; Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Time to the 1st rescue analgesia	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.	48 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean arterial pressure	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 min till the end of surgery
Heart rate	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Every 15 min till the end of surgery
Intraoperative fentanyl consumption	Additional fentanyl bolus dosages of 1 µg/kg IV will be administered if heart rate or mean arterial blood pressure elevated more than 20% of the baseline.	Intraoperatively
Total morphine consumption	Rescue analgesia of morphine will be given as 3 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the NRS < 4.	48 hours postoperatively
Degree of pain	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.	48 hours postoperatively
Incidence of adverse events	Incidence of adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be recorded.	48 hours postoperatively

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): November 14, 2024
• Primary Completion (Actual): July 7, 2025
• Study Completion (Actual): July 7, 2025

Study Registration Dates

• First Submitted: November 11, 2024
• First Submitted That Met QC Criteria: November 11, 2024
• First Posted (Actual): November 12, 2024

Study Record Updates

• Last Update Posted (Actual): July 24, 2025
• Last Update Submitted That Met QC Criteria: July 23, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 36264PR904/10/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No