Clinical trial NCT06945263: Comparing Pain Relief Between Two Methods of Freezing Injections in Children Having Their Appendix Removed
Official title: Rectus Sheath Block and Coadministration of Intravenous Dexamethasone for Analgesia After Pediatric Laparoscopic Appendectomy - A Pilot Study
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Laparoscopic Appendectomy
Keywords: Rectus Sheath Block
Dexamethasone
Laparoscopic Appendectomy
Analgesia
Anesthesia
Local Anesthetic
Lead sponsor: University of British Columbia
Sponsor class: OTHER
Collaborators: name: BC Children's Hospital Research Institute
First posted: 2025-04-25
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).


Eligibility criteria: 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

Primary outcomes:
measure: Total opioid administration
timeFrame: From the start of surgery until up to 16 hours post-operatively.
Secondary outcomes:
measure: Mean postoperative pain score at 12 hours
timeFrame: 12 hours postoperatively
measure: Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively
timeFrame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.
measure: Time spent performing rectus sheath block
timeFrame: Intraoperatively.
measure: Duration of anesthesia care unit (ACU) stay
timeFrame: Perioperatively.
measure: Duration of post-procedural hospitalization
timeFrame: Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.
measure: Parental perspective on patient postoperative pain
timeFrame: 24 to 72 hours postoperatively
measure: Non-prescription postoperative drugs
timeFrame: 24 to 72 hours postoperatively
measure: Parental satisfaction with recovery
timeFrame: 24 to 72 hours postoperatively.
measure: Mean Postoperative Pain Score at 12 Hours
timeFrame: 12 hours postoperatively
measure: Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively
timeFrame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: British Columbia Children's Hospital
state: British Columbia
Study officials:
affiliation: University of British Columbia
name: Prakash Krishnan, MD
role: PRINCIPAL_INVESTIGATOR
References:
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