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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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06363578
Enrollment
50
Registered
2024-04-12
Start date
2024-04-20
Completion date
2025-03-08
Last updated
2025-03-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dexmedetomidine, External Oblique Intercostal Plane Block, Splenectomy

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.

Interventions

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

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

Sponsors

Tanta University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Time to the 1st rescue analgesia48 hour PostoperativelyRescue 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

MeasureTime frameDescription
Total morphine consumption48 hour postoperativelyRescue 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).
Degree of pain48 hours postoperativelyEach 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.
Intraoperative fentanyl consumptionIntraoperativelyAdditional 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).
Mean arterial pressureTill the end of surgeryMean arterial pressure will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.
The incidence of adverse events48 hour postoperativelyAdverse events such as local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, respiratory depression, or any other complication will be measured.
Heart rateTill the end of surgeryHeart rate will be recorded preoperative, before performing of block, and every 15 min till the end of surgery.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026