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Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis

NCT04717193 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 42

Last updated 2024-03-12

No results posted yet for this study

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.

Conditions

  • Appendicitis Acute

Interventions

DRUG

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

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

PROCEDURE

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

Infiltration of local anesthetic at incision sites.

Sponsors & Collaborators

  • University of Alberta

    lead OTHER

Principal Investigators

  • Troy Perry, MD · University of Alberta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
8 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-05-28
Primary Completion
2023-04-17
Completion
2023-04-17

Countries

  • Canada

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04717193 on ClinicalTrials.gov