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NCT Number: NCT07138781

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

The aim of this study is to evaluate the role of ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

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Key information

Conditions

Ketamine 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

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.
  • Severe cardiovascular problems.

Treatment and study plan

ketamine

Drug

Patients will receive 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg).

29 ml bupivacaine 0.25% + 1 ml saline

Drug

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

Primary outcomes

  1. Time to the 1st rescue analgesia

    Time frame: 48 hours postoperatively

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

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 (after exclusion of other causes than pain).

  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) score. 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. Mean arterial pressure

    Time frame: Till the end of surgery (Up to 2 hours)

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

  5. Heart rate

    Time frame: Till the end of surgery (Up to 2 hours)

    Heart rate 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 Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Controlled Trial

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 24, 2025
Registry last updated
Feb 27, 2026

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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