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

Not Applicable

Recruiting

• Conditions: Ketamine; Adjuvant; External Oblique Intercostal Plane Block; Thoracotomy; Pain
• Interventions: Drug: Ketamine; Drug: 29 ml bupivacaine 0.25% + 1 ml saline

• Registration Number: NCT07138781
• Lead Sponsor: Tanta University

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study First Submitted: 2025-08-17
• Study First Submitted QC: 2025-08-17
• Study Start: 2025-08-23
• Last Update Submitted: 2025-08-23
• Study First Posted: 2025-08-24
• Last Update Posted: 2025-08-26
• Primary Completion: 2026-02-01
• Study Completion: 2026-02-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group K	Ketamine	Patients will receive 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) as a study group.
Group C	29 ml bupivacaine 0.25% + 1 ml saline	Patients will receive 29 ml bupivacaine 0.25% + 1 ml saline as a control group.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	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 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 (after exclusion of other causes than pain).
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.
Mean arterial pressure	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.
Degree of pain	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.
Heart rate	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.
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