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

NCT06945263 | Enrolling By Invitation

• 2 other identifiers: H23-03547F23-05308
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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).

Conditions

Laparoscopic Appendectomy

Keywords

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

Outcome Measures

Primary Outcomes (1)

• Total opioid administration

  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 Outcomes (10)

• Mean postoperative pain score at 12 hours

  12 hours postoperatively

• Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively

  0 hours, 4 hours, 8 hours, and 16 hours postoperatively.

• Time spent performing rectus sheath block

  Intraoperatively.

• Duration of anesthesia care unit (ACU) stay

  Perioperatively.

• Duration of post-procedural hospitalization

  Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.

Study Arms (2)

Rectus Sheath Block with Intravenous Dexamethasone

EXPERIMENTAL

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; Drug: Intravenous Dexamethasone; Drug: Local Anesthetic at the Incision Site

Local Anesthetic

ACTIVE COMPARATOR

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 Umbilical Port Site; Drug: Local Anesthetic at the Incision Site

Interventions

Rectus Sheath Block PROCEDURE

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.

Rectus Sheath Block with Intravenous Dexamethasone

Local Anesthetic at the Umbilical Port Site DRUG

0.25% bupivacaine with epinephrine 1:200 000. Total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site.

Local Anesthetic

Intravenous Dexamethasone DRUG

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

Rectus Sheath Block with Intravenous Dexamethasone

Local Anesthetic at the Incision Site DRUG

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.

Local Anesthetic; Rectus Sheath Block with Intravenous Dexamethasone

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Age 4-18 years old
• Diagnosed with acute appendicitis.
• Undergoing a laparoscopic appendectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of British Columbia: lead
• BC Children's Hospital Research Institute: collaborator

Study Sites (1)

British Columbia Children's Hospital

Vancouver, British Columbia, V6H 3N1, Canada

Location

Related Publications (17)

• Pearson AME, Roberts S, Turbitt LR. New blocks on the kids: core basic nerve blocks in paediatric anaesthesia. Anaesthesia. 2023 Jan;78(1):3-8. doi: 10.1111/anae.15876. Epub 2022 Oct 11. No abstract available.

  PMID: 36220155 BACKGROUND

• Shafy SZ, Miller R, Uffman JC, Tobias JD, Fetzer M, Nordin AB, Kenney B, Walia H, Veneziano G. An Enhanced Recovery Protocol that Facilitates Same-day Discharge for Simple Laparoscopic Appendectomies. Pediatr Qual Saf. 2019 Dec 5;4(6):e243. doi: 10.1097/pq9.0000000000000243. eCollection 2019 Nov-Dec.

  PMID: 32010869 BACKGROUND

• Gee K, Ngo S, Burkhalter L, Beres AL. Safety and feasibility of same-day discharge for uncomplicated appendicitis: A prospective cohort study. J Pediatr Surg. 2018 May;53(5):988-990. doi: 10.1016/j.jpedsurg.2018.02.031. Epub 2018 Feb 9.

  PMID: 29510871 BACKGROUND

• Cairo SB, Raval MV, Browne M, Meyers H, Rothstein DH. Association of Same-Day Discharge With Hospital Readmission After Appendectomy in Pediatric Patients. JAMA Surg. 2017 Dec 1;152(12):1106-1112. doi: 10.1001/jamasurg.2017.2221.

  PMID: 28678998 BACKGROUND

• Alkhoury F, Burnweit C, Malvezzi L, Knight C, Diana J, Pasaron R, Mora J, Nazarey P, Aserlind A, Stylianos S. A prospective study of safety and satisfaction with same-day discharge after laparoscopic appendectomy for acute appendicitis. J Pediatr Surg. 2012 Feb;47(2):313-6. doi: 10.1016/j.jpedsurg.2011.11.024.

  PMID: 22325382 BACKGROUND

• Cheng O, Cheng L, Burjonrappa S. Facilitating factors in same-day discharge after pediatric laparoscopic appendectomy. J Surg Res. 2018 Sep;229:145-149. doi: 10.1016/j.jss.2018.03.072. Epub 2018 Apr 25.

  PMID: 29936981 BACKGROUND

• Pehora C, Pearson AM, Kaushal A, Crawford MW, Johnston B. Dexamethasone as an adjuvant to peripheral nerve block. Cochrane Database Syst Rev. 2017 Nov 9;11(11):CD011770. doi: 10.1002/14651858.CD011770.pub2.

  PMID: 29121400 BACKGROUND

• Edinoff AN, Houk GM, Patil S, Bangalore Siddaiah H, Kaye AJ, Iyengar PS, Cornett EM, Imani F, Mahmoudi K, Kaye AM, Urman RD, Kaye AD. Adjuvant Drugs for Peripheral Nerve Blocks: The Role of Alpha-2 Agonists, Dexamethasone, Midazolam, and Non-steroidal Anti-inflammatory Drugs. Anesth Pain Med. 2021 Jul 4;11(3):e117197. doi: 10.5812/aapm.117197. eCollection 2021 Jun.

  PMID: 34540647 BACKGROUND

• Desai N, Albrecht E. Local anaesthetic adjuncts for peripheral nerve blockade. Curr Opin Anaesthesiol. 2023 Oct 1;36(5):533-540. doi: 10.1097/ACO.0000000000001272. Epub 2023 Jun 14.

  PMID: 37314172 BACKGROUND

• Maloney C, Kallis M, El-Shafy IA, Lipskar AM, Hagen J, Kars M. Ultrasound-guided bilateral rectus sheath block vs. conventional local analgesia in single port laparoscopic appendectomy for children with nonperforated appendicitis. J Pediatr Surg. 2018 Mar;53(3):431-436. doi: 10.1016/j.jpedsurg.2017.05.027. Epub 2017 Jun 2.

  PMID: 28610706 BACKGROUND

• Hamill JK, Liley A, Hill AG. Rectus sheath block for laparoscopic appendicectomy: a randomized clinical trial. ANZ J Surg. 2015 Dec;85(12):951-6. doi: 10.1111/ans.12950. Epub 2015 Jan 12.

  PMID: 25581711 BACKGROUND

• Hamill JK, Rahiri JL, Liley A, Hill AG. Rectus sheath and transversus abdominis plane blocks in children: a systematic review and meta-analysis of randomized trials. Paediatr Anaesth. 2016 Apr;26(4):363-71. doi: 10.1111/pan.12855. Epub 2016 Feb 4.

  PMID: 26846889 BACKGROUND

• Russell P, von Ungern-Sternberg BS, Schug SA. Perioperative analgesia in pediatric surgery. Curr Opin Anaesthesiol. 2013 Aug;26(4):420-7. doi: 10.1097/ACO.0b013e3283625cc8.

  PMID: 23756911 BACKGROUND

• Bosenberg A. Benefits of regional anesthesia in children. Paediatr Anaesth. 2012 Jan;22(1):10-8. doi: 10.1111/j.1460-9592.2011.03691.x. Epub 2011 Sep 7. No abstract available.

  PMID: 21895855 BACKGROUND

• Yu TC, Hamill JK, Liley A, Hill AG. Warm, humidified carbon dioxide gas insufflation for laparoscopic appendicectomy in children: a double-blinded randomized controlled trial. Ann Surg. 2013 Jan;257(1):44-53. doi: 10.1097/SLA.0b013e31825f0721.

  PMID: 22824858 BACKGROUND

• Shim H, Gan TJ. Side effect profiles of different opioids in the perioperative setting: are they different and can we reduce them? Br J Anaesth. 2019 Sep;123(3):266-268. doi: 10.1016/j.bja.2019.06.009. Epub 2019 Jul 17. No abstract available.

  PMID: 31326087 BACKGROUND

• Tomecka MJ, Bortsov AV, Miller NR, Solano N, Narron J, McNaull PP, Ricketts KJ, Lupa CM, McLean SA. Substantial postoperative pain is common among children undergoing laparoscopic appendectomy. Paediatr Anaesth. 2012 Feb;22(2):130-5. doi: 10.1111/j.1460-9592.2011.03711.x. Epub 2011 Sep 29.

  PMID: 21958060 BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Prakash Krishnan, MD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Assistant Professor

Study Record Dates

• First Submitted: April 3, 2025
• First Posted: April 25, 2025
• Study Start: May 1, 2025
• Primary Completion: April 27, 2026
• Study Completion: April 27, 2026
• Last Updated: May 16, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)