Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis

• Status: Recruiting
• Trial end date: 2022-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Alberta
• Treatments: Anesthetics; Anesthetics, Local; Bupivacaine; Epinephrine; Epinephryl borate; Racepinephrine

Criteria

Inclusion Criteria:

• Diagnosis of acute uncomplicated appendicitis

• Age 8-17 years

Exclusion Criteria:

• Complicated appendicitis, perforation, abscess

• History of chronic pain condition or long-term analgesic use

• History of bleeding condition

• Condition preventing accurate documentation of post-operative pain scores using the FPS-R tool including severe developmental delay, psychiatric illness, or partially sighted or blindness

• Previous open abdominal surgery

• Presence of an abdominal prosthesis such as a gastrostomy tube or ventricular-peritoneal shunt device

• Allergy to bupivacaine or morphine