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

Dexmedetomidine Clinical Trial

Official title:

Comparison Between Role of Dexmedetomidine and Ketamine as an Adjuvant in External Oblique Intercostal Plane Block for Post Thoracotomy Pain: A Randomized Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06331182
• Other study ID #: 36264PR552/2/24
• Status: Recruiting
• Phase: N/A
• Start date: March 26, 2024
• Est. completion date: August 1, 2024

Study information

• Verified date: March 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 role of dexmedetomidine and ketamine as an adjuvant in external oblique intercostal plane block for post thoracotomy pain.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 40
• Est. completion date: August 1, 2024
• Est. primary completion date: August 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

• Dexmedetomidine
• Ketamine
• Post Thoracotomy Pain

Intervention

Drug:
• 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.
• 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.
• Bupivacaine
29 ml bupivacaine 0.25%

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	ElGharbia

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to the 1st rescue analgesia	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.	48 hours postoperative.
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	Total morphine consumption in the 1st 24hr and 48 hr	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")	48 hours postoperatively.
Secondary	Degree of pain	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.	48 hours postoperatively.
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	Mean arterial blood	Mean arterial blood will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.	Till the end of surgery.
Secondary	The incidence of adverse events	Adverse events such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication.	48 hours postoperative