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

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

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.

Study Overview

• Status: Completed
• Conditions: Dexmedetomidine; Splenectomy; External Oblique Intercostal Plane Block
• Intervention / Treatment: Drug: Dexmedetomidine 0.5 μg/kg; Drug: Dexmedetomidine 1 μg/kg

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 Type: Interventional
• Enrollment (Actual): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El-Gharbia
    • Tanta, El-Gharbia, Egypt, 31527
      • Tanta University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Group dexmedetomidine 0.5; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg diluted in saline.	Drug: Dexmedetomidine 0.5 μg/kg; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 0.5 μg/kg diluted in saline.
Experimental: Group dexmedetomidine1; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.	Drug: Dexmedetomidine 1 μg/kg; Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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
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
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

Collaborators and Investigators

• Sponsor: Tanta University

Study record dates

Study Major Dates

• Study Start (Actual): April 20, 2024
• Primary Completion (Actual): March 8, 2025
• Study Completion (Actual): March 8, 2025

Study Registration Dates

• First Submitted: April 9, 2024
• First Submitted That Met QC Criteria: April 9, 2024
• First Posted (Actual): April 12, 2024

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 9, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Central Nervous System Depressants; Sensory System Agents; Analgesics, Non-Narcotic; Analgesics; Neurotransmitter Agents; Hypnotics and Sedatives; Adrenergic alpha-2 Receptor Agonists; Adrenergic alpha-Agonists; Adrenergic Agonists; Adrenergic Agents; Dexmedetomidine
• Other Study ID Numbers: 36264PR604/3/24

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: The data will be available upon a reasonable request from the corresponding author after the end of study for one year.
• IPD Sharing Time Frame: After the end of study for one year.
• IPD Sharing Access Criteria: The data will be available upon a reasonable request from the corresponding author
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No