Different Doses of Dexmedetomidine in External Oblique Intercostal Plane Block in Splenectomy

Dexmedetomidine Clinical Trial

Official title:

Comparing the Analgesic Effects of Different Doses of Dexmedetomidine as an Adjuvant in External Oblique Intercostal Plane Block in Splenectomy: A Randomized Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06363578
• Other study ID #: 36264PR604/3/24
• Status: Not yet recruiting
• Phase: N/A
• Start date: April 20, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: April 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 analgesic effects of different doses of dexmedetomidine as an adjuvant in external oblique intercostal plane block (EOIPB) in splenectomy.

Description:

External oblique intercostal plane block (EOIPB) was reported by Elsharkawy et al . It is a novel block, which has been described as an important modification of the fascial plane blocks that can consistently involve the upper lateral abdominal walls. In comparison to quadratus lumborum block (QLB) and erector spinae plane block (ESPB) , EOIPB has the benefit of being performed when the patient is supine. It also has an advantage over serratus intercostal plane block (SIPB) in that it produces greater analgesia throughout the midline of the abdomen.

Dexmedetomidine is used for sedation in patients admitted to the intensive care unit (ICU). Dexmedetomidine is a selective alpha 2- adrenoceptor agonist possessing sedative, anxiolytic, and analgesic properties without the development of respiratory depression . Several studies have shown that dexmedetomidine has an anesthetic sparing effect, which has led to its use as a general adjuvant for prolonging peripheral nerve block duration.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 50
• Est. completion date: October 1, 2024
• Est. primary completion date: October 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 II-III.

• Scheduled for splenectomy.

Exclusion Criteria:

• Body mass index (BMI) =35 kg/m2

• History of abdominal surgery.

• Infection at the injection site.

• Drug abuse.

• Allergic reaction to local anesthetics.

• Coagulation abnormalities.

• Pregnancy.

• Severe cardiovascular problems.

• Diabetic neuropathy.

Related Conditions & MeSH terms

• Dexmedetomidine
• Splenectomy

Intervention

Drug:
• Dexmedetomidine 0.5 µg/kg
Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 µg/kg diluted in saline.
• Dexmedetomidine 1 µg/kg
Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 µg/kg diluted in saline.

Locations

Country	Name	City	State
Egypt	Tanta University	Tanta	El-Gharbia

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	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.; 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").	48 hour Postoperatively
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).	Intraoperatively
Secondary	Total morphine consumption	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.; 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").	48 hour postoperatively
Secondary	Degree of pain	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").; Numerical rating Scale (NRS) 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 pressure	Mean arterial pressure 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 local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be measured.	48 hour postoperatively