CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 42 enrolled
Drug / intervention
Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04717193
NCT04717193Phase 2Completed

Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis - a Randomized Control Trial

University of Alberta·interventional·Posted Jan 22, 2021·Updated Mar 12, 2024

In Brief

A Phase 2 clinical trial evaluating Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine and Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine for Appendicitis Acute. Completed, enrolled 42 participants across 1 site.

Detailed Summary

The study will investigate the pain control effects of a rectus sheath block after laparoscopic surgery to remove the appendix. A rectus sheath block is the injection of local anesthetic (numbing agent) into the space between the muscles of the belly wall. Children having surgery for appendicitis age 8-17 at the Stollery Children's Hospital will be eligible to participate. Patients with complicated appendicitis (perforation or abscess), chronic pain, bleeding disorders, or inability to document pain scores will be excluded from this study. Participants will be randomly assigned to either rectus sheath block or standard local anesthetic. The standard local anesthetic group will have local anesthetic (numbing agent) injected around their surgery cut sites. The rectus sheath block group will have this standard plus the rectus sheath block with local anesthetic. Participants, parents, anesthesiologists and nursing staff will not know which group the participant has been assigned to. The surgeon will know the group. The same pain and nausea medications will be ordered for all participants after the surgery. Pain scores will be measured using the Faces Pain Scale - Revised tool. Participants will be asked to rate their pain in the recovery room, in their hospital room at 3 and 6 hours after the surgery and again before going home. This tool has been shown to be useful for rating children's pain levels. The study will also measure the amount of pain and nausea medications that participants are given during their surgery and recovery. Participants will see their surgeon at 6 weeks after their surgery where they will be asked about any problems after being discharged home. Data will be analyzed with a linear mixed model.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedJan 22, 2021
Enrollment StartMay 28, 2021
Primary CompletionApr 17, 2023
TodayJul 2, 2026
Enrollment to primary: 1.9 yearsPosted 5.4 years ago

Interventions

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

Bilateral rectus sheath block plus infiltration local anesthetic at incision sites.

Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrineprocedure

Infiltration of local anesthetic at incision sites.