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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06331182
Other study ID # 36264PR552/2/24
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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.

Study Design


Related Conditions & MeSH terms


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
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