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NCT Number: NCT07075913

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

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.

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Key information

Conditions

Analgesic Efficacy Dexmedetomidine Erector Spinae Plane Block Laparoscopic Cholecystectomy Subcostal Transverse Abdominis Plane Block

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Kafrelsheikh University

Kafr ash Shaykh, Kafrelsheikh, 33516, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

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

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.

Treatment and study plan

Subcostal transverse abdominis plane block

Other

Patients received an ultrasound-guided subcostal transverse abdominis plane block with injection of 10 ml bupivacaine 0.25 %, 5ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Erector spinae plane block

Other

Patients will receive an ultrasound-guided erector spinae plane block (ESPB) with injection of 10 ml bupivacaine 0.25%, 5 ml lignocaine 2 % plus 0.5 μg/kg dexmedetomidine in a 20 ml volume.

Primary outcomes

  1. 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

  1. Heart rate

    Time frame: 24 hours postoperatively

    Heart rate was recorded at baseline, after injection then every 30 minutes till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 16 and 24 h.

  2. Mean arterial pressure

    Time frame: 24 hours postoperatively

    Mean arterial pressure was recorded at baseline, after injection then every 30 minutes till the end of surgery and after surgery at 0, 2, 4, 6, 8, 12, 16 and 24 h.

  3. Intraoperative opioid consumption

    Time frame: Intraoperatively

    Intraoperative opioid consumption was recorded.

  4. Time to first rescue analgesia

    Time frame: 24 hours postoperatively

    Time to first rescue analgesia was recorded from the end of surgery till first dose of morphine administrated.

  5. Degree of pain

    Time frame: 24 hours postoperatively

    Visual analogue scale (VAS) was assessed after surgery at 0, 2, 4, 6, 8, 12, 16, 18, and 24 h [where (0 = no pain and 10 = severe pain)].

  6. Incidence of complications

    Time frame: 24 hours postoperatively

    Incidence of complications such as pneumothorax, local anesthetic systemic toxicity (LAST), bradycardia, hypotension, nausea, vomiting, and failed block were recorded.

  7. Patient satisfaction

    Time frame: 24 hours postoperatively

    Degree of patient satisfaction will be assessed on a 3-point scale; (1= Unsatisfied, 2= neither satisfied nor unsatisfied, 3= satisfied).

Sponsors and collaborators

Lead sponsor

Kafrelsheikh University

Other

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 20, 2025
Registry last updated
Jul 20, 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.

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