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

NCT ID: NCT06363578

Last Updated: 2025-03-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-20
• Study Completion Date: 2025-03-08

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.

Conditions

Dexmedetomidine; External Oblique Intercostal Plane Block; Splenectomy

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

Group dexmedetomidine 0.5

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

Group Type: EXPERIMENTAL

Dexmedetomidine 0.5 μg/kg

Intervention Type: DRUG

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

Group dexmedetomidine1

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.

Group Type: EXPERIMENTAL

Dexmedetomidine 1 μg/kg

Intervention Type: DRUG

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.

Interventions

Dexmedetomidine 0.5 μg/kg

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

Intervention Type: DRUG

Dexmedetomidine 1 μg/kg

Patients will receive 29 ml bupivacaine 0.25% + 1 ml dexmedetomidine 1 μg/kg diluted in saline.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Tanta University

OTHER

Sponsor Role: lead

Responsible Party

Mohammed Said ElSharkawy

Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Tanta University

Tanta, El-Gharbia, Egypt

Countries

Egypt

Other Identifiers

36264PR604/3/24

Identifier Type: -

Identifier Source: org_study_id