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

Thoracic Paravertebral Block Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06431880
• Other study ID #: 36246PR638/4/24
• Status: Not yet recruiting
• Phase: N/A
• Start date: May 30, 2024
• Est. completion date: December 1, 2024

Study information

• Verified date: May 2024
• Source: Tanta University
• Contact: Mohammed S Elsharkawy, MD
• Phone: 00201148207870
• Email: mselsharkawy[@]med.tanta.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. completion date: December 1, 2024
• Est. primary completion date: December 1, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aortic Dissection
• Post Thoracotomy Pain
• Thoracic Paravertebral Block

Intervention

Other:
• External oblique intercostal plane block
Patients will receive external oblique intercostal plane block
• Thoracic paravertebral block
Patients will receive thoracic paravertebral block

Locations

Country	Name	City	State
Egypt	Tanta University Hospitals	Tanta	El-Gharbia Governorate, Egypt

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total morphine consumption	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.	24 hours postoperatively
Secondary	Intraoperative fentanyl consumption	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).	Intraoperative
Secondary	Mean arterial pressure	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery
Secondary	Heart rate	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery
Secondary	Time to the 1st rescue analgesia	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	24 hours postoperatively
Secondary	Degree of pain	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.	24 hours postoperatively
Secondary	Complications	Complications such as bradycardia, hypotension, nausea, vomiting, respiratory depression, local anesthetic systemic toxicity (LAST) or any other complication will be recorded.	24 hour postoperatively