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

NCT06363578 | Completed

• 1 other identifier: 36264PR604/3/24
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dexmedetomidine; External Oblique Intercostal Plane Block; Splenectomy

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Intraoperative fentanyl consumption

  Intraoperatively

• Total morphine consumption

  48 hour postoperatively

• Degree of pain

  48 hours postoperatively

• Heart rate

  Till the end of surgery

• Mean arterial pressure

  Till the end of surgery

Study Arms (2)

Group dexmedetomidine 0.5

EXPERIMENTAL

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

Drug: Dexmedetomidine 0.5 μg/kg

Group dexmedetomidine1

EXPERIMENTAL

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

Drug: Dexmedetomidine 1 μg/kg

Interventions

Dexmedetomidine 0.5 μg/kg DRUG

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

Group dexmedetomidine 0.5

Dexmedetomidine 1 μg/kg DRUG

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

Group dexmedetomidine1

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years.
• Both sexes.
• American Society of Anesthesiology (ASA) physical status II-III.
• Scheduled for splenectomy.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Tanta University: lead

Study Sites (1)

Tanta University

Tanta, El-Gharbia, 31527, Egypt

Location

MeSH Terms

Interventions

Dexmedetomidine

Intervention Hierarchy (Ancestors)

Imidazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Anesthesiology, Surgical Intensive Care and Pain Medicine, Faculty of Medicine, Tanta University, Tanta, Egypt.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: April 20, 2024
• Primary Completion: March 8, 2025
• Study Completion: March 8, 2025
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: After the end of study for one year.
• Access Criteria: The data will be available upon a reasonable request from the corresponding author

Locations

EG (1)