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Clinical Trials/NCT06363578
NCT06363578
Completed
Not Applicable

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

Tanta University1 site in 1 country50 target enrollmentApril 20, 2024

Overview

Phase
Not Applicable
Intervention
Dexmedetomidine 0.5 μg/kg
Conditions
Dexmedetomidine
Sponsor
Tanta University
Enrollment
50
Locations
1
Primary Endpoint
Time to the 1st rescue analgesia
Status
Completed
Last Updated
last year

Overview

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.

Registry
clinicaltrials.gov
Start Date
April 20, 2024
End Date
March 8, 2025
Last Updated
last year
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Responsible Party
Principal Investigator
Principal Investigator

Mohammed Said ElSharkawy

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

Tanta University

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.

Arms & Interventions

Group dexmedetomidine 0.5

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

Intervention: Dexmedetomidine 0.5 μg/kg

Group dexmedetomidine1

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

Intervention: Dexmedetomidine 1 μg/kg

Outcomes

Primary Outcomes

Time to the 1st rescue analgesia

Time Frame: 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 Outcomes

  • Heart rate(Till the end of surgery)
  • Intraoperative fentanyl consumption(Intraoperatively)
  • Mean arterial pressure(Till the end of surgery)
  • Total morphine consumption(48 hour postoperatively)
  • Degree of pain(48 hours postoperatively)
  • The incidence of adverse events(48 hour postoperatively)

Study Sites (1)

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