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Completed

NCT Number: NCT06431880

External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain

The aim of this study is to compare the effectiveness of analgesia achieved by external oblique intercostal plane block (EOIPB)and thoracic paravertebral block (TPVB) for postoperative pain management in patients undergoing open thoracotomy.

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Key information

Conditions

External Oblique Intercostal Plane Block Post Thoracotomy Pain Thoracic Paravertebral Block

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University Hospitals

Tanta, El-Gharbia Governorate, Egypt, 31527, Egypt

About this study

Acute thoracotomy pain is multifactorial in nature. It involves nociceptive and neuropathic mechanisms originating from somatic and visceral afferents. The main sources of pain are intercostal nerves, the vagus nerve and phrenic nerve in the pleura, the superficial cervical plexus, and the brachial plexus in the ipsilateral shoulder.

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.
  • Opioid addiction.
  • Allergic reaction to local anesthetics.
  • Coagulation abnormalities.
  • Drug abuse.
  • Pregnancy.
  • Severe liver and/or renal failure.
  • Uncontrolled hypertension.
  • Severe cardiovascular problems.
  • Diabetes mellitus.

Treatment and study plan

External Oblique Intercostal Plane Block

Other

Patients will receive external oblique intercostal plane block

Thoracic paravertebral block

Other

Patients will receive thoracic paravertebral block

Primary outcomes

  1. Total morphine consumption

    Time frame: 24 hours postoperatively

    Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale (NRS) > 3 to be repeated after 30 min if pain persists until the numeric rating scale < 4. numeric rating scale will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

Secondary outcomes

  1. Intraoperative fentanyl consumption

    Time frame: Intraoperative

    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 (after exclusion of other causes than pain).

  2. Mean arterial pressure

    Time frame: 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.

  3. Heart rate

    Time frame: Till the end of surgery

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

  4. Time to the 1st rescue analgesia

    Time frame: 24 hours postoperatively

    All patients will receive paracetamol 1 gm every 6 h as routine analgesia. Rescue analgesia of morphine will be given as 2 mg bolus if the numeric rating scale > 3 to be repeated after 30 min if pain persists until the numeric rating scale < 4. NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively

  5. Degree of pain

    Time frame: 24 hours postoperatively

    Degree of pain will be measured using numeric rating scale (NRS) (0 represents "no pain" while 10 represents "the worst pain imaginable").NRS will be assessed at 0, 4, 8, 12, 18 and 24h postoperatively.

  6. Complications

    Time frame: 24 hour postoperatively

    Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

External Oblique Intercostal Plane Block Versus Thoracic Paravertebral Block for Post Thoracotomy Pain: A Randomized Non-inferiority Trial

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 29, 2024
Registry last updated
Aug 19, 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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