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NCT Number: NCT06640062

Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy

The aim of this work was to compare the effect of using oblique subcostal transversus abdominis plane (OSTAP) block and erector spinae plane (ESP) block as a part of multi-modal analgesia technique in patients undergoing laparoscopic cholecystectomy.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Helwan University

Helwan, Cairo Governorate, 11795, Egypt

About this study

Laparoscopic cholecystectomy is a commonly performed surgery and requires multi-modal analgesia for better control of pain. Untreated post-operative pain has many consequences, including patient dissatisfaction, transition into chronic pain, delayed discharge from the hospital, and increased healthcare costs.

Many inter-fascial plane blocks like oblique subcostal transversus abdominis plane (OSTAP) block and recently, erector spinae plane (ESP) block have been utilized as a part of multi modal analgesia technique in many abdominal surgeries.

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 gender.
  • American Society of Anesthesiologists (ASA) grade I and II physical status.
  • Body mass index (BMI): ≥ 20 kg/m2 and ≤ 35 kg/m2.
  • Underwent laparoscopic cholecystectomy.

Exclusion criteria

  • Patient refusal.
  • Known sensitivity or contraindication to drugs used in the study (local anesthetics, opioids).
  • History of psychological disorders and/or chronic pain syndrome.
  • Contraindication to regional anesthesia, e.g., local sepsis, pre-existing peripheral neuropathies, and coagulopathy.
  • Severe respiratory disorders such as (severe obstructive pulmonary disease, forced expiratory volume (FEV1), forced vital capacity (FVC) <50% or severe restrictive pulmonary disease, and adult respiratory distress syndrome).
  • Severe cardiac disorders such as (heart failure).
  • Advanced liver disease (elevated liver enzymes more than 3 folds of normal range).
  • Advanced kidney disease (Decreased creatinine clearance <40 ml/min).
  • Pregnancy.

Treatment and study plan

Erector spinae plane block

Other

Patients received ultrasound-guided erector spinae plane block.

Oblique subcostal transversus abdominis plane block

Other

Patients received ultrasound-guided oblique subcostal transversus abdominis plane block.

Primary outcomes

  1. Degree of pain intensity

    Time frame: 24 hours postoperatively

    The degree of pain intensity was assessed using the Visual Analogue Scale (VAS). Each patient was instructed about postoperative pain assessment with the VAS. VAS(0 represents "no pain" while 10 represents "the worst pain imaginable"). It was assessed at 30 minutes, 2, 4, 6, 8, 12, 16, 20, and 24 hours postoperatively.

Secondary outcomes

  1. Time to first rescue analgesia

    Time frame: 24 hours postoperatively

    Time to first rescue analgesia was assessed from the end of surgery to the first dose of morphine administrated

  2. Total amount of morphine consumption

    Time frame: 24 hours postoperatively

    When a patient complains of pain equivalent to the Visual Analogue Scale (VAS) ≥ 3, rescue analgesia is given in the form of morphine (0.05mg/kg) intravenous increments, as needed.

  3. Morphine-related side effects

    Time frame: 24 hours postoperatively

    Morphine-related side effects such as incidence of nausea and vomiting, respiratory depression (respiratory rate < 8 breaths/min), bradycardia (heart rate decreases by > 20% of basal reading), pruritus, and urine retention were recorded.

  4. Local anesthetics-related side effects

    Time frame: 24 hours postoperatively

    Local anesthetics-related side effects such as lightheadedness, circumoral numbness, tongue paresthesia, drowsiness, irritability, muscle twitches, convulsions, bradycardia, hypotension (mean arterial blood pressure decreases by > 20% of basal reading), hypoventilation and cardiac arrest were recorded.

  5. Incidence of adverse effects of the block technique

    Time frame: 24 hours postoperatively

    Signs of adverse effects of the block techniques, such as local site infection, hematoma formation, bowel perforation, or pneumothorax, were recorded.

Sponsors and collaborators

Lead sponsor

Helwan University

Other

Registry information

Official study title

Evaluation of Ultrasound-Guided Erector Spinae Plane Block Versus Oblique Subcostal Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Comparative Study

Important dates

Study start
2023
Primary completion
2024
Study completion
2024
First posted
Oct 15, 2024
Registry last updated
Oct 15, 2024

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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