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Clinical Trials/NCT06431880
NCT06431880
Completed
Not Applicable

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

Tanta University1 site in 1 country90 target enrollmentMay 30, 2024

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
External Oblique Intercostal Plane Block
Sponsor
Tanta University
Enrollment
90
Locations
1
Primary Endpoint
Total morphine consumption
Status
Completed
Last Updated
8 months ago

Overview

Brief Summary

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.

Detailed Description

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.

Registry
clinicaltrials.gov
Start Date
May 30, 2024
End Date
June 1, 2025
Last Updated
8 months ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Tanta University

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • Mean arterial pressure(Till the end of surgery)
  • Degree of pain(24 hours postoperatively)
  • Heart rate(Till the end of surgery)
  • Time to the 1st rescue analgesia(24 hours postoperatively)
  • Intraoperative fentanyl consumption(Intraoperative)
  • Complications(24 hour postoperatively)

Study Sites (1)

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