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

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

Status
Enrolling by invitation
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06945263
Enrollment
32
Registered
2025-04-25
Start date
2025-05-01
Completion date
2026-04-27
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Laparoscopic Appendectomy

Keywords

Rectus Sheath Block, Dexamethasone, Laparoscopic Appendectomy, Analgesia, Anesthesia, Local Anesthetic

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).

Interventions

PROCEDURERectus 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.

DRUGLocal 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.

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

DRUGLocal 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.

Sponsors

BC Children's Hospital Research Institute
CollaboratorOTHER
University of British Columbia
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Caregiver)

Eligibility

Sex/Gender
ALL
Age
4 Years to 18 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Total opioid administrationFrom 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

MeasureTime frameDescription
Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively0 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.
Time spent performing rectus sheath blockIntraoperatively.Time performing the rectus sheath block in minutes as recorded by the anesthesiologist.
Duration of anesthesia care unit (ACU) stayPerioperatively.Time between ACU admission and discharge.
Duration of post-procedural hospitalizationBaseline (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.
Mean postoperative pain score at 12 hours12 hours postoperativelyDiscrete 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.
Non-prescription postoperative drugs24 to 72 hours postoperativelyWhich non-prescription drugs are administered post-operatively from the parent to the patient.
Parental satisfaction with recovery24 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.
Mean Postoperative Pain Score at 12 Hours12 hours postoperativelyDiscrete 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.
Parental perspective on patient postoperative pain24 to 72 hours postoperativelyParental 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026