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Enrolling by Invitation

NCT Number: NCT06945263

Comparing Pain Relief Between Two Methods of Freezing Injections in Children Having Their Appendix Removed

Laparoscopic appendectomies are the most common emergency surgeries performed in children. Despite being considered minimally invasive surgeries, they can result in substantial postoperative pain and 2 of 3 patients require postoperative opioids. Increased postoperative pain can delay recovery, increase hospital admission time, lead to chronic pain, and cause patient distress. This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with coadministration of IV dexamethasone as an LA adjunct (RSB+dex group) prior to the incision with (2) LA infiltration alone by the surgeon (LA group).

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Key information

Conditions

Laparoscopic Appendectomy Agnosia Nervous System Diseases Neurobehavioral Manifestations Neurologic Manifestations Pathological Conditions, Signs and Symptoms Perceptual Disorders Signs and Symptoms

Age range

4 year–18 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Age 4-18 years old
  • Diagnosed with acute appendicitis.
  • Undergoing a laparoscopic appendectomy

Exclusion criteria

  • Perforated/complicated appendicitis diagnosis
  • Previous abdominal surgery
  • Allergy to bupivacaine or dexamethasone
  • Severe developmental delay preventing patients from using pain scales or adequately communicating pain
  • Patients with Type 1 or 2 diabetes mellitus
  • Patients with steroid dependence

Treatment and study plan

Rectus sheath block

Procedure

Bilateral rectus sheath blocks using an in-plane ultrasound-guided technique with 0.25% bupivacaine with epinephrine 1:200 000 at 0.8 mL/kg (half of total volume per side) up to a maximum of 20 mL prior to the incision.

Local Anesthetic at the Umbilical Port Site

Drug

0.25% bupivacaine with epinephrine 1:200 000. Total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site.

intravenous dexamethasone

Drug

Intravenous Dexamethasone delivered concurrent to the RSB. Total dose of 150 mcg/kg up to a maximum of 8 mg.

Local Anesthetic at the Incision Site

Drug

The remaining volume of local anesthetic (0.2 mL/kg) can be infiltrated at each of the incision sites at the discretion of the surgeon up to a maximum of 10 mL.

Primary outcomes

  1. Total opioid administration

    Time frame: From the start of surgery until up to 16 hours post-operatively.

    Continuous variable measured by collecting and totaling all opioid (excluding remifentanil) administrations from intraoperative, anesthetic care unit (ACU), and ward records and converting to morphine milligram per kilogram equivalents.

Secondary outcomes

  1. Mean postoperative pain score at 12 hours

    Time frame: 12 hours postoperatively

    Discrete variable measured via age-appropriate visual analog scale (Faces Pain Scale-Revised) for participants who are younger than 12 years old. The Faces Pain Scale is on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  2. Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively

    Time frame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

    Discrete variable measured via age-appropriate visual analog scale (FACES Pain Scale-Revised) for participants who are younger than 12 years old. The Faces Pain Scale is on a scale of 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  3. Time spent performing rectus sheath block

    Time frame: Intraoperatively.

    Time performing the rectus sheath block in minutes as recorded by the anesthesiologist.

  4. Duration of anesthesia care unit (ACU) stay

    Time frame: Perioperatively.

    Time between ACU admission and discharge.

  5. Duration of post-procedural hospitalization

    Time frame: Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.

    Duration from entering the operating room to hospital discharge in minutes.

  6. Parental perspective on patient postoperative pain

    Time frame: 24 to 72 hours postoperatively

    Parental assessment of patient postoperative pain using a numeric rating scale. The scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  7. Non-prescription postoperative drugs

    Time frame: 24 to 72 hours postoperatively

    Which non-prescription drugs are administered post-operatively from the parent to the patient.

  8. Parental satisfaction with recovery

    Time frame: 24 to 72 hours postoperatively.

    Discrete 5-point scale (very unsatisfied, unsatisfied, neutral, satisfied, very satisfied) measuring parental satisfaction with patient recovery. Very unsatisfied is the worse outcome, very satisfied is the best outcome.

  9. Mean Postoperative Pain Score at 12 Hours

    Time frame: 12 hours postoperatively

    Discrete variable measured via age-appropriate scale (Numeric Rating Scale) for participants who are 12 years old or older. The numeric rating scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

  10. Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively

    Time frame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

    Discrete variable measured via age-appropriate scale (Numeric Rating Scale) for participants who are 12 years old or older. The numeric rating scale is from 0 to 10, where 0 is no pain and 10 is the worst pain imaginable.

Sponsors and collaborators

Lead sponsor

University of British Columbia

Other

Collaborators

  • BC Children's Hospital Research Institute

Registry information

Official study title

Rectus Sheath Block and Coadministration of Intravenous Dexamethasone for Analgesia After Pediatric Laparoscopic Appendectomy - A Pilot Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Apr 25, 2025
Registry last updated
May 16, 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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