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Clinical Trials/NCT07075913
NCT07075913
Completed
Not Applicable

Analgesic Efficacy of Adding Dexmedetomidine to Erector Spinae Plane Block Versus Subcostal Transverse Abdominis Plane Block in Laparoscopic Cholecystectomy

Kafrelsheikh University1 site in 1 country40 target enrollmentStarted: May 1, 2024Last updated:

Overview

Phase
Not Applicable
Status
Completed
Enrollment
40
Locations
1
Primary Endpoint
Total dose of morphine consumption

Overview

Brief Summary

Our scientific work aimed to evaluate the analgesic efficacy of dexmedetomidine as an adjuvant to erector spinae plane block versus subcostal transverse abdominis plane block in patients undergoing laparoscopic cholecystectomy.

Detailed Description

Laparoscopic cholecystectomy (LC) is the most commonly performed surgical procedure for the management of cholelithiasis. Acute pain after LC consists of somatic, parietal, and referred pain caused by trocar insertion, gall bladder resection, carbon dioxide insufflation, and other factors.

The subcostal transverse abdominis plane (SCTAP) block is the deposition of local anesthetic in the transverse abdominis plane inferior and parallel to the costal margin.

Ultrasound-guided erector spinae plane block (ESPB) is a popular, interfascial regional technique initially described for managing thoracic neuropathic pain.

Dexmedetomidine is an alpha-2 adrenergic receptor agonist that has been the focus of interest due to its sedative, analgesic, perioperative sympatholytic, and cardiovascular-stabilizing effects, resulting in reduced anesthetic requirements.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Participant, Outcomes Assessor)

Eligibility Criteria

Ages
20 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Age from 20 to 60 years.
  • Both sexes.
  • American Society of Anesthesiologists (ASA) physical status I and II.
  • Patients were planned to undergo laparoscopic cholecystectomy.

Exclusion Criteria

  • Patient's refusal to participate in the study.
  • ASA III, IV.
  • History of clinically significant cardiac, hepatic, renal, respiratory or neurological disease.
  • Coagulopathy and bleeding disorders.
  • Known allergy to any drug included in the study.
  • Systemic or local infection at the puncture site.
  • Body mass index (BMI) \>35 (kg/m2).
  • Failed technique.

Outcomes

Primary Outcomes

Total dose of morphine consumption

Time Frame: 24 hours postoperatively

If the Visual analogue scale (VAS) is ≥ 3, IV morphine was given as a bolus of 2 mg (body weight \< or = 60 kg) or 3 mg (body weight \> 60 kg) with 5 minutes' lockout interval.

Secondary Outcomes

  • Heart rate(24 hours postoperatively)
  • Mean arterial pressure(24 hours postoperatively)
  • Intraoperative opioid consumption(Intraoperatively)
  • Time to first rescue analgesia(24 hours postoperatively)
  • Degree of pain(24 hours postoperatively)
  • Incidence of complications(24 hours postoperatively)
  • Patient satisfaction(24 hours postoperatively)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Lamees Elsayed Ali Soliman Shaloof

Resident of Anesthesia, Surgical Intensive Care and Pain Therapy, Faculty of Medicine, Kafr-Elsheikh University, Kafr-Elsheikh, Egypt.

Kafrelsheikh University

Study Sites (1)

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