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

Not Applicable

Completed

• Conditions: Post Thoracotomy Pain; Ketamine; Dexmedetomidine; External Oblique Intercostal Plane Block
• Interventions: Drug: Ketamine; Drug: Dexmedetomidine; Drug: Bupivacaine

• Registration Number: NCT06331182
• Lead Sponsor: Tanta University

Brief Summary

The aim of this study is to compare the role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

Detailed Description

Postsurgical pain in patients who have undergone open thoracotomy for lung cancer or other lung surgeries is known to be very severe.

As a result, this pain alters spontaneous breathing, delays postoperative recovery, and persists as chronic post-thoracotomy pain syndrome . Post-thoracotomy pain syndrome is relatively common and is seen in approximately 50% of patients after thoracotomy. It is a chronic condition, and about 30% of patients might still experience pain 4 to 5 years after surgery.

Study Timeline

• Study First Submitted: 2024-03-17
• Study First Submitted QC: 2024-03-25
• Study Start: 2024-03-26
• Study First Posted: 2024-03-26
• Primary Completion: 2024-11-01
• Study Completion: 2024-11-01
• Status Verified: 2025-01
• Last Update Submitted: 2025-01-06
• Last Update Posted: 2025-01-07

Recruitment & Eligibility

• Status: COMPLETED
• 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.
• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Ketamine group	Bupivacaine	Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
Ketamine group	Ketamine	Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml ketamine (50 mg) after induction of general anesthesia.
Dex group	Dexmedetomidine	Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.
Dex group	Bupivacaine	Patients will receive external oblique intercostal plane block using 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg after induction of general anesthesia.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	48 hours postoperative.	A standardized analgesic regimen will be prescribed in the post-operative period. All patients will receive paracetamol 1 gm every 6 h as routine analgesia. 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. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.

Secondary Outcome Measures

Name	Time	Method
Intraoperative fentanyl consumption	Intraoperative	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 in the 1st 24hr and 48 hr	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. NRS will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.; NRS (0 represents "no pain" while 10 represents "the worst pain imaginable")
Degree of pain	48 hours postoperatively.	Degree of pain will be assessed by the numeric rating scale (NRS). NRS (0 represents "no pain" while 10 represents "the worst pain imaginable"). It will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
Heart rate	Till the end of surgery.	Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
The incidence of adverse events	48 hours postoperative	Adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication.
Mean arterial blood	Till the end of surgery.	Mean arterial blood will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, ElGharbia, Egypt