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

Not Applicable

Recruiting

• Conditions: Dexmedetomidine; Adjuvant; External Oblique Intercostal Plane Block; Thoracotomy; Pain
• Interventions: Drug: Dexmedetomidine; Drug: Saline

• Registration Number: NCT06684535
• Lead Sponsor: Tanta University

Brief Summary

This study aims to evaluate the role of dexmedetomidine as an adjuvant in external oblique intercostal plane block for post-thoracotomy pain.

Detailed Description

External oblique intercostal plane block (EOIPB) is a novel block that has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls.

Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression.

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-11
• Study First Submitted QC: 2024-11-11
• Study First Posted: 2024-11-12
• Study Start: 2024-11-14
• Last Update Submitted: 2024-11-14
• Last Update Posted: 2024-11-15
• Primary Completion: 2025-04-01
• Study Completion: 2025-04-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 40

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.
• Drug abuse.
• Allergic reaction to local anesthetics.
• Coagulation abnormalities.
• Pregnancy.
• Body Mass Index (BMI) ≥35 kg/m2.
• Severe cardiovascular problems.
• Diabetic neuropathy.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dexmedetomidine group	Dexmedetomidine	Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg.
Control group	Saline	Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	48 hours postoperatively	Time to the first request for the rescue analgesia (time from end of surgery to first dose of morphine administrated) will be recorded.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	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.
Total morphine consumption	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.
Degree of pain	48 hours postoperatively	Each patient will be instructed about postoperative pain assessment with the numeric rating scale (NRS). 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.
Heart rate	Every 15 min till the end of surgery	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Mean arterial pressure	Every 15 min 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.
Incidence of adverse events	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.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt