Skip to main content
OpenTrials
Completed

NCT Number: NCT06363578

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Dexmedetomidine External Oblique Intercostal Plane Block Splenectomy

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tanta University

Tanta, El-Gharbia, 31527, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Dexmedetomidine 0.5 μg/kg

Drug

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

Dexmedetomidine 1 μg/kg

Drug

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

Primary outcomes

  1. 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

  1. Intraoperative fentanyl consumption

    Time frame: 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).

  2. Total morphine consumption

    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").

  3. Degree of pain

    Time frame: 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.

  4. Heart rate

    Time frame: Till the end of surgery

    Heart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

  5. Mean arterial pressure

    Time frame: 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.

  6. The incidence of adverse events

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Apr 12, 2024
Registry last updated
Mar 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.