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

Not Applicable

Completed

• Conditions: Dexmedetomidine; External Oblique Intercostal Plane Block; Splenectomy
• Interventions: Drug: Dexmedetomidine 1 μg/kg; Drug: Dexmedetomidine 0.5 μg/kg

• Registration Number: NCT06363578
• Lead Sponsor: Tanta University

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2024-04-09
• Study First Submitted QC: 2024-04-09
• Study First Posted: 2024-04-12
• Study Start: 2024-04-20
• Status Verified: 2025-03
• Primary Completion: 2025-03-08
• Study Completion: 2025-03-08
• Last Update Submitted: 2025-03-09
• Last Update Posted: 2025-03-11

Recruitment & Eligibility

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

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group dexmedetomidine1	Dexmedetomidine 1 μg/kg	Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.
Group dexmedetomidine 0.5	Dexmedetomidine 0.5 μg/kg	Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg diluted in saline.

Primary Outcome Measures

Name	Time	Method
Time to the 1st rescue analgesia	48 hour 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.; 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").

Secondary Outcome Measures

Name	Time	Method
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.
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).
Mean arterial pressure	Till the end of surgery	Mean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
Total morphine consumption	48 hour 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.; 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").
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").; Numerical rating Scale (NRS) will be assessed at 0, 4, 8, 12, 18, 24, 36 and 48 h postoperatively.
The incidence of adverse events	48 hour postoperatively	Adverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be measured.

Trial Locations

Locations (1)

Tanta University; 🇪🇬 Tanta, El-Gharbia, Egypt