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NCT Number: NCT06684535

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

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

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Key information

Conditions

Dexmedetomidine Adjuvant External Oblique Intercostal Plane Block Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms Thoracotomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine

Drug

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

Saline

Drug

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

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 48 hours postoperatively

    Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperatively

    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.

  2. Total morphine consumption

    Time frame: 48 hours postoperatively

    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.

  3. Degree of pain

    Time frame: 48 hours postoperatively

    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.

  4. Heart rate

    Time frame: Every 15 min till the end of surgery

    Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

  5. Mean arterial pressure

    Time frame: Every 15 min till the end of surgery

    Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

  6. Incidence of adverse events

    Time frame: 48 hours postoperatively

    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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Nov 12, 2024
Registry last updated
Jul 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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