Laparoscopically Guided Rectus Sheath Block in Pediatric Appendicitis

  • STATUS
    Recruiting
  • days left to enroll
    89
  • participants needed
    100
  • sponsor
    University of Alberta
Updated on 4 October 2022

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.

Description

Purpose

To determine if a bilateral laparoscopically guided rectus sheath block improves pain control over conventional local anesthetic infiltration around port site incisions following laparoscopic appendectomy.

Hypothesis

Bilateral rectus sheath block will improve post-operative pain scores following laparoscopic appendectomy for acute uncomplicated appendicitis.

Justification

Children have significant pain after laparoscopic appendectomy and many receive post-operative opioids for analgesia. The Faces pain scale - revised (FPS-R) is a simple validated method of measuring post-operative pain in children. Ultrasound-guided bilateral rectus sheath block (RSB) has been shown to decrease pain scores in the early post-operative period following pediatric laparoscopic appendectomy and elective umbilical hernia repair.2,4 The use of image-guidance for needle placement has improved both achievement of appropriate anatomic location of the block as well as analgesia associated with the block. Under ultrasound guidance, this extra step requires additional equipment, time, and sometimes dedicated personnel to complete. The investigators propose a bilateral RSB performed intra-operatively under laparoscopic guidance may alleviate the need for these extra resources while achieving the desired analgesic effects.

The analgesic effect of the standard of care injection of local anesthesia is limited to the superficial layers of the abdominal wall. The rectus sheath block targets the nerves running within the fascia and provides a more complete block to the deep and superficial layers of the abdominal wall.

Objectives

Primary Objective: Determine if intra-operative laparoscopic guided bilateral RSB improves self-reported post-operative pain scores at 3 hours post-operatively.

Secondary Objectives:

Determine if intra-operative laparoscopic guided bilateral RSB improves self-reported post-operative pain scores in the PACU, at 6 hours post-operatively, and prior to discharge home.

Determine if intra-operative bilateral laparoscopic guided bilateral RSB decreases intra-operative narcotic use, post-operative opioid use, and post-operative antiemetic use.

Research Methods/Procedures:

Randomization: Simple

Blinding: Single-blind. Surgeon cannot be blinded to the intervention. Anesthesiologist, participants, parents, and nursing staff in the OR, recovery room, and ward will be blinded.

Control: Standard of care infiltration of local anesthetic at incisions.

Treatment and standard care arms will run in parallel.

Standard Care: Intra-operative infiltration of 2ml of 0.25% Bupivacaine with 1:200 000 epinephrine at each port site incision.

Experimental Treatment: Bilateral RSB with up to 7ml of 0.25% Bupivacaine with 1:200 000 epinephrine plus 2ml infiltrated around each port site incision as in the standard care group. The total volume used will not exceed 20ml or 2mg/kg, whichever is lower.

Each participant will be followed in the recovery room and surgical ward and asked to report their pain level immediately after surgery, at 3 and 6 hours after surgery, and prior to discharge home. Each participant will have a scheduled follow up visit at 6 weeks with their operating surgeon where they will be asked about any complications experienced since discharge.

Participation will be voluntary. Participants will receive standard of care if they choose not to participate in the study. Informed consent will be obtained from the participant's parent or legal guardian by the operating surgeon or delegate pre-operatively. Participants will be asked to provide assent.

Plan for Data Analysis:

100 participants will be required with a target of 50 in each group. Sample size calculations were completed based on an estimated 20% effect size with consideration for a potential 10-15% dropout rate to achieve a power of 80% and alpha 5%. Effect size is estimated conservatively from data in previous studies showing an average 30% decrease in early post-operative pain scores.

Data will be analyzed in an intent to treat manner using a linear mixed model. We have undertaken an initial consultation with a WCHRI biostatistician.

Details
Condition Appendicitis Acute
Treatment Rectus Sheath Block with 0.25% bupivicaine with 1:200 000 epinephrine, Local Anesthetic Infiltration with 0.25% bupivicaine with 1:200 000 epinephrine
Clinical Study IdentifierNCT04717193
SponsorUniversity of Alberta
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
Clear my responses

How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

You are contacting

Investigator Avatar

Primary Contact

site

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Loading...

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer

user name

Added by • 

 • 

Private

Reply by • Private
Loading...

Lorem ipsum dolor sit amet consectetur, adipisicing elit. Ipsa vel nobis alias. Quae eveniet velit voluptate quo doloribus maxime et dicta in sequi, corporis quod. Ea, dolor eius? Dolore, vel!

  The passcode will expire in None.
Loading...

No annotations made yet

Add a private note
  • abc Select a piece of text from the left.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.
Add a private note