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

University of British Columbia

Status: Not yet enrolling

Conditions: Laparoscopic Appendectomy

Treatments: Drug: Intravenous Dexamethasone; Drug: Local Anesthetic at the Incision Site; Procedure: Rectus Sheath Block; Drug: Local Anesthetic at the Umbilical Port Site

Study type: Interventional

Funder types: Other

Identifiers

NCT06945263

F23-05308 (Other Grant/Funding Number)

H23-03547

Details and patient eligibility

About

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).

Enrollment: 32 estimated patients

Sex: All

Ages: 4 to 18 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

32 participants in 2 patient groups

Rectus Sheath Block with Intravenous Dexamethasone

Experimental group

Description:

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.

Treatment:

Drug: Local Anesthetic at the Incision Site

Procedure: Rectus Sheath Block

Drug: Intravenous Dexamethasone

Local Anesthetic

Active Comparator group

Description:

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.

Treatment:

Drug: Local Anesthetic at the Umbilical Port Site

Drug: Local Anesthetic at the Incision Site