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

NCT06684535 | Completed

• 1 other identifier: 36264PR904/10/24
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Dexmedetomidine; Adjuvant; External Oblique Intercostal Plane Block; Thoracotomy; Pain

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intraoperative fentanyl consumption

  Intraoperatively

• Total morphine consumption

  48 hours postoperatively

• Degree of pain

  48 hours postoperatively

• Heart rate

  Every 15 min till the end of surgery

• Mean arterial pressure

  Every 15 min till the end of surgery

Study Arms (2)

Dexmedetomidine group

EXPERIMENTAL

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.

Drug: Dexmedetomidine

Control group

ACTIVE COMPARATOR

Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.

Drug: Saline

Interventions

Dexmedetomidine DRUG

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.

Dexmedetomidine group

Saline DRUG

Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.

Control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Conditions

Pain

Interventions

Dexmedetomidine; Sodium Chloride

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: November 11, 2024
• First Posted: November 12, 2024
• Study Start: November 14, 2024
• Primary Completion: July 7, 2025
• Study Completion: July 7, 2025
• Last Updated: July 24, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author.

Locations

EG (1)