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

Overview

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

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

Primary outcome measures

• Total opioid administration [Time frame: From the start of surgery until up to 16 hours post-operatively.]

Secondary outcome measures (10)

• Mean postoperative pain score at 12 hours [Time frame: 12 hours postoperatively]
• Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively [Time frame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.]
• Time spent performing rectus sheath block [Time frame: Intraoperatively.]
• Duration of anesthesia care unit (ACU) stay [Time frame: Perioperatively.]
• Duration of post-procedural hospitalization [Time frame: Baseline (upon entering the operating room) to discharge from hospital, an average of 16 hours.]
• Parental perspective on patient postoperative pain [Time frame: 24 to 72 hours postoperatively]
• Non-prescription postoperative drugs [Time frame: 24 to 72 hours postoperatively]
• Parental satisfaction with recovery [Time frame: 24 to 72 hours postoperatively.]
• Mean Postoperative Pain Score at 12 Hours [Time frame: 12 hours postoperatively]
• Pain scores at 0 hours, 4 hours, 8 hours, and 16 hours postoperatively [Time frame: 0 hours, 4 hours, 8 hours, and 16 hours postoperatively.]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Single blind

Primary purpose

Treatment

Study locations

Canada · 1 center

• British Columbia Children's Hospital — Vancouver

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06945263 · H23-03547 · F23-05308

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗