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Local Anesthetic

Rectus Sheath Block for Pediatric Appendicitis

Phase 2

Waitlist Available

Led By Troy Perry, MD

Research Sponsored by University of Alberta

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Diagnosis of acute uncomplicated appendicitis

Age 8-17 years

Timeline

Screening 3 weeks

Treatment Varies

Follow Up intra-operative

Awards & highlights

Study Summary

This trial will investigate the pain control effects of a rectus sheath block after laparoscopic surgery to remove the appendix in children ages 8-17.

Who is the study for?

This trial is for children aged 8-17 with acute uncomplicated appendicitis at Stollery Children's Hospital. It excludes those with chronic pain, bleeding disorders, abdominal prostheses, allergies to specific anesthetics, conditions affecting pain score reporting (like severe developmental delays), previous open abdominal surgery or complicated appendicitis.Check my eligibility

What is being tested?

The study compares the effectiveness of a rectus sheath block versus standard local anesthetic infiltration in managing post-surgery pain for pediatric appendectomy. Participants are randomly assigned to one of these two approaches and their pain and nausea levels will be monitored using standardized tools.See study design

What are the potential side effects?

Potential side effects may include reactions to the bupivacaine such as numbness beyond the target area, weakness, dizziness or allergic reactions. There might also be typical surgical risks like infection or bleeding at the injection site.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I have been diagnosed with a simple case of appendicitis.

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I am between 8 and 17 years old.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ approximately 24 hours

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~approximately 24 hours

This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 24 hours for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Self-reported pain scores at 3 hours post-operatively

Secondary outcome measures

Intra-operative narcotic use in mg/kg morphine equivalents

Post-operative anti-emetic use mg/kg or ondansetron and dimenhydrinate

Post-operative narcotic use in mg/kg morphine equivalents

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: Rectus Sheath BlockExperimental Treatment1 Intervention

Participants randomized to the experimental arm will receive a bilateral rectus sheath block which is additional to the standard of care (infiltration of 5mg (2mL) 0.25% bupivacaine with epinephrine around port site incisions). For rectus sheath block, use the formula Volume (ml) = 2mg/kg x weight (kg) divided by 2.5mg/ml - 6ml to a maximum of 14ml. Maximum total dose is 2mg/kg. Participants will be asked to rate their pain a total of 4 times for the study. Each occurrence is expected to take approximately 1-2 minutes to complete. There will be no additional follow-up required as part of the study. The 6 week follow-up visit is standard routine practice.

Group II: Local AnestheticActive Control1 Intervention

Participants in the control arm will receive the standard care which is infiltration of 5mg (2mL) of 0.25% bupivacaine with epinephrine around port site incisions. Participants will be asked to rate their pain a total of 4 times for the study. Each occurrence is expected to take approximately 1-2 minutes to complete. There will be no additional follow-up required as part of the study. The 6 week follow-up visit is standard routine practice.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine

2021

Completed Phase 2

~50

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

University of AlbertaLead Sponsor

886 Previous Clinical Trials

384,736 Total Patients Enrolled

Troy Perry, MDPrincipal InvestigatorUniversity of Alberta

Media Library

Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine (Local Anesthetic) Clinical Trial Eligibility Overview. Trial Name: NCT04717193 — Phase 2

Appendicitis Research Study Groups: Local Anesthetic, Rectus Sheath Block

Appendicitis Clinical Trial 2023: Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine Highlights & Side Effects. Trial Name: NCT04717193 — Phase 2

Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine (Local Anesthetic) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04717193 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any restrictions for participants in this clinical trial?

"This clinical trial is testing a new treatment for appendicitis in children aged 8-17. They are looking for around 100 participants total."

Answered by AI

If an individual is below the age of 75, can they participate in this trial?

"Children aged 8 to 17 years old may be eligible for this trial, which would involve 25 patients in total. There are 36 other trials underway that study individuals over the age of 65."

Answered by AI

How many individuals are receiving therapy in this research project?

"Yes, the information on clinicaltrials.gov indicates that this trial is actively recruiting patients. The trial was first posted on May 28th, 2021 and updated July 11th, 2022. They are looking for 100 participants at 1 site."

Answered by AI

Are participants being enrolled in this experiment right now?

"The listing on clinicaltrials.gov suggests that this study is currently open for enrollment. The trial was first posted on May 28th, 2021 and was last updated on July 11th, 2022. They are hoping to enroll 100 patients at 1 site."

Answered by AI

Has the FDA greenlit Rectus Sheath Block with 0.25% bupivicaine and 1:200 000 epinephrine?

"There is limited data backing the safety of Rectus Sheath Block with 0.25% bupivicaine and 1:200 000 epinephrine, which scored a 2 on our team's scale."

Answered by AI

Are there any other similar ongoing studies to this one involving Rectus Sheath Block with 0.25% bupivicaine and 1:200 000 epinephrine?

"There are a total of 33 clinical trials researching Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine, 5 of which are in Phase 3. The many studies for Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine mostly based in Baltimore, Maryland, but there are 52 locations running these tests altogether."

Answered by AI

What is the common purpose of Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine?

"Rectus Sheath Block with 0.25% bupivicaine and 1:200 000 epinephrine can help patients suffering from hypotension as well as unresponsive bradycardia, pupil dilation, and open angle glaucoma (oag)."

Answered by AI

Recent research and studies

ANZ Journal of SurgeryJournal

Rectus Sheath Block for Laparoscopic Appendicectomy: A Randomized Clinical Trial

Hamill, James K., Andrew Liley, and Andrew G. Hill. 2015. “Rectus Sheath Block for Laparoscopic Appendicectomy: A Randomized Clinical Trial”. ANZ Journal of Surgery. Wiley. doi:10.1111/ans.12950.

JAMA SurgeryJournal

Ultrasonography-guided Bilateral Rectus Sheath Block Vs Local Anesthetic Infiltration After Pediatric Umbilical Hernia Repair

Dingeman, R. Scott, Lindsay M. Barus, Hyun Kee Chung, David J. Clendenin, Christopher S. Lee, Sarah Tracy, Victor M. Johnson, Kate V. Dennett, David Zurakowski, and Catherine Chen. 2013. “Ultrasonography-guided Bilateral Rectus Sheath Block Vs Local Anesthetic Infiltration After Pediatric Umbilical Hernia Repair”. JAMA Surgery. American Medical Association (AMA). doi:10.1001/jamasurg.2013.1442.

PainJournal

The Faces Pain Scale – Revised: Toward a Common Metric in Pediatric Pain Measurement

Hicks, Carrie L., Carl L. von Baeyer, Pamela A. Spafford, Inez van Korlaar, and Belinda Goodenough. 2001. “The Faces Pain Scale – Revised: Toward a Common Metric in Pediatric Pain Measurement”. Pain. Ovid Technologies (Wolters Kluwer Health). doi:10.1016/s0304-3959(01)00314-1.

Pediatric AnesthesiaJournal