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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06431880
Enrollment
90
Registered
2024-05-29
Start date
2024-05-30
Completion date
2025-06-01
Last updated
2025-08-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

External Oblique Intercostal Plane Block, Post Thoracotomy Pain, Thoracic Paravertebral Block

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.

Interventions

OTHERExternal oblique intercostal plane block

Patients will receive external oblique intercostal plane block

OTHERThoracic paravertebral block

Patients will receive thoracic paravertebral block

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Total morphine consumption24 hours postoperativelyRescue 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

MeasureTime frameDescription
Mean arterial pressureTill the end of surgeryMean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Heart rateTill the end of surgeryHeart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Intraoperative fentanyl consumptionIntraoperativeAdditional 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).
Degree of pain24 hours postoperativelyDegree 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.
Complications24 hour postoperativelyComplications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.
Time to the 1st rescue analgesia24 hours postoperativelyAll 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

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026