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

May 14, 2025 updated by: Prakash Krishnan, University of British Columbia

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

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).

Study Overview

Status

Enrolling by invitation

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

32

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3N1
        • British Columbia Children's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rectus Sheath Block with Intravenous Dexamethasone
The rectus sheath block (RSB) is already current standard of care for laparoscopic appendectomy patients and is used by providers at the British Columbia Children's Hospital. The RSB group will receive up to a maximum of 1 mL/kg total of local anesthetic, which will ensure the total volume calculation for each arm will receive a bupivacaine dose at or below 2.5 mg/kg body weight. The anesthesia team will perform the bilateral RSBs 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. The surgical team will then use the remaining 0.2 mL/kg to infiltrate the remaining port sites in RSB groups. Intravenous Dexamethasone will be administered concurrently.
Procedure: Rectus Sheath Block
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.
Drug: Intravenous Dexamethasone
Intravenous Dexamethasone delivered concurrent to the RSB. Total dose of 150 mcg/kg up to a maximum of 8 mg.
Drug: Local Anesthetic at the Incision Site
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.
Active Comparator: Local Anesthetic
Local anesthetic at the incision site is also current standard of care for appendectomy patients and is used by providers at the British Columbia Children's Hospital. This group will receive up to a maximum of 1 mL/kg total of LA which will ensure the total volume calculation for each arm would receive a bupivacaine dose at or below 2.5 mg/kg body weight. The local anesthetic infiltration arm will receive the same local anesthetic as the rectus sheath block arm (0.25% bupivacaine with epinephrine 1:200 000), injected by the surgeon. Surgeons can inject up to a total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site. 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.
Drug: Local Anesthetic at the Incision Site
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.
Drug: Local Anesthetic at the Umbilical Port Site
0.25% bupivacaine with epinephrine 1:200 000. Total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From the start of surgery until up to 16 hours post-operatively.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12 hours postoperatively
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.
0 hours, 4 hours, 8 hours, and 16 hours postoperatively.
Time spent performing rectus sheath block
Time Frame: Intraoperatively.
Time performing the rectus sheath block in minutes as recorded by the anesthesiologist.
Intraoperatively.
Duration of anesthesia care unit (ACU) stay
Time Frame: Perioperatively.
Time between ACU admission and discharge.
Perioperatively.
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.
Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.
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.
24 to 72 hours postoperatively
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.
24 to 72 hours postoperatively
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.
24 to 72 hours postoperatively.
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.
12 hours postoperatively
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.
0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of British Columbia

Collaborators

BC Children's Hospital Research Institute

Investigators

  • Principal Investigator: Prakash Krishnan, MD, University of British Columbia

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2025

Primary Completion (Estimated)

April 27, 2026

Study Completion (Estimated)

April 27, 2026

Study Registration Dates

First Submitted

April 3, 2025

First Submitted That Met QC Criteria

April 22, 2025

First Posted (Actual)

April 25, 2025

Study Record Updates

Last Update Posted (Actual)

May 16, 2025

Last Update Submitted That Met QC Criteria

May 14, 2025

Last Verified

May 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H23-03547
  • F23-05308 (Other Grant/Funding Number: BC Children's Hospital Research Institute)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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