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

Not Applicable

• Conditions: Laparoscopic Appendectomy
• Interventions: Procedure: Rectus Sheath Block; Drug: Local Anesthetic at the Umbilical Port Site; Drug: Intravenous Dexamethasone; Drug: Local Anesthetic at the Incision Site

• Registration Number: NCT06945263
• Lead Sponsor: University of British Columbia

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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-03
• Study First Submitted QC: 2025-04-22
• Study First Posted: 2025-04-25
• Status Verified: 2025-05
• Study Start: 2025-05-01
• Last Update Submitted: 2025-05-14
• Last Update Posted: 2025-05-16
• Primary Completion: 2026-04-27
• Study Completion: 2026-04-27

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 32

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Rectus Sheath Block with Intravenous Dexamethasone	Rectus Sheath Block	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.
Rectus Sheath Block with Intravenous Dexamethasone	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.
Rectus Sheath Block with Intravenous Dexamethasone	Local Anesthetic at the Incision Site	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.
Local Anesthetic	Local Anesthetic at the Umbilical Port Site	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.
Local Anesthetic	Local Anesthetic at the Incision Site	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.

Primary Outcome Measures

Name	Time	Method
Total opioid administration	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 Outcome Measures

Name	Time	Method
Time spent performing rectus sheath block	Intraoperatively.	Time performing the rectus sheath block in minutes as recorded by the anesthesiologist.
Duration of anesthesia care unit (ACU) stay	Perioperatively.	Time between ACU admission and discharge.
Duration of post-procedural hospitalization	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.
Mean postoperative pain score at 12 hours	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.
Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively	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.
Parental perspective on patient postoperative pain	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.
Non-prescription postoperative drugs	24 to 72 hours postoperatively	Which non-prescription drugs are administered post-operatively from the parent to the patient.
Parental satisfaction with recovery	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.
Mean Postoperative Pain Score at 12 Hours	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.

Trial Locations

Locations (1)

British Columbia Children's Hospital; 🇨🇦 Vancouver, British Columbia, Canada