Pain Relief Methods for Laparoscopic Appendectomy in Children

Overseen By Prakash Krishnan, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: University of British Columbia

Must not be taking: Steroids

Disqualifiers: Complicated appendicitis, Abdominal surgery, Diabetes, others

Stay on Your Current Meds You can continue your current medications while participating

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: Intraoperative

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to find better ways to manage pain after children undergo laparoscopic appendectomies (a surgery to remove an inflamed appendix using small cuts). Researchers are comparing two treatments: one group will receive a rectus sheath block (a type of numbing injection) with dexamethasone (an anti-inflammatory drug) to help reduce pain; the other group will receive a local anesthetic directly at the surgery site. The goal is to determine which method helps children recover with less pain and fewer opioids. The trial seeks children aged 4 to 18 diagnosed with simple appendicitis and scheduled for this surgery. As an unphased trial, this study offers a unique opportunity to contribute to research that could improve post-surgical care for children.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. However, if you are dependent on steroids, you cannot participate in this trial.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that rectus sheath blocks (RSB) can relieve pain in children undergoing laparoscopic appendectomies, a surgery to remove the appendix. Studies indicate that RSB reduces the need for additional pain medication, suggesting it is generally well-tolerated. Adding intravenous dexamethasone, a steroid, to RSB might enhance pain relief further.

The local anesthetic method is already standard practice, with a proven safety record. Both methods use bupivacaine, a common local anesthetic known for its effectiveness and safety when used in appropriate amounts.

Overall, the treatments under study have been successfully used in similar situations, suggesting they are safe options for managing pain in children after surgery. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these pain relief methods for laparoscopic appendectomy in children because they aim to optimize how local anesthetics are used. The Rectus Sheath Block with Intravenous Dexamethasone is unique as it combines a common anesthetic technique with a steroid to potentially enhance pain relief and reduce inflammation. Meanwhile, the Local Anesthetic approach focuses on precision in anesthetic delivery at the umbilical port site, which could improve pain management by targeting the most sensitive areas. Both methods use bupivacaine, known for its long-lasting effects, but tweak the administration to potentially increase effectiveness and comfort for young patients.

What evidence suggests that this trial's treatments could be effective for reducing postoperative pain in children undergoing laparoscopic appendectomy?

This trial will compare different pain relief methods for children undergoing laparoscopic appendectomy. Research has shown that a rectus sheath block (RSB) with dexamethasone administered through an IV can significantly improve post-surgery pain relief for children. Participants in this trial may receive RSB with dexamethasone, which studies have found reduces the need for painkillers, such as opioids, after surgery, leading to better pain control. Another group in this trial will receive a local anesthetic at the surgery site, the usual method for pain management. However, this method might not reduce the need for opioids as effectively as RSB with dexamethasone. Overall, RSB with dexamethasone appears promising for reducing pain and opioid use in children undergoing this surgery. ^{2 3 4 5 6}

Who Is on the Research Team?

Prakash Krishnan, MD

Principal Investigator

University of British Columbia

Are You a Good Fit for This Trial?

This trial is for children undergoing minimally invasive surgery to remove their appendix. It's designed to find better ways to manage pain after the operation. To join, kids must be having this specific surgery and fit the study's health requirements.

Inclusion Criteria

I have been diagnosed with acute appendicitis.

I am having surgery to remove my appendix using a camera.

Exclusion Criteria

I have had surgery in my abdomen before.

I have Type 1 or Type 2 diabetes.

Allergy to bupivacaine or dexamethasone

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants undergo laparoscopic appendectomy with either rectus sheath block and intravenous dexamethasone or local anesthetic infiltration

Intraoperative

1 visit (in-person)

Postoperative Monitoring

Participants are monitored for pain scores and opioid administration up to 16 hours postoperatively

16 hours

Follow-up

Participants are monitored for safety and effectiveness after treatment, including parental assessments and non-prescription drug use

24 to 72 hours

What Are the Treatments Tested in This Trial?

Interventions

• Intravenous Dexamethasone
• Local Anesthetic at the Incision Site
• Local Anesthetic at the Umbilical Port Site

Trial Overview The study compares two pain relief methods: one group receives a rectus sheath block with IV dexamethasone before being cut (RSB+dex), while the other gets local anesthetics at incision sites (LA). The goal is to see which method reduces post-surgery pain more effectively.

How Is the Trial Designed?

Group I: Rectus Sheath Block with Intravenous Dexamethasone Experimental Treatment 3 Interventions

The rectus sheath block (RSB) is already current standard of care for laparoscopic appendectomy patients and is used by providers at the British Columbia Children's Hospital. The RSB group will receive up to a maximum of 1 mL/kg total of local anesthetic, which will ensure the total volume calculation for each arm will receive a bupivacaine dose at or below 2.5 mg/kg body weight. The anesthesia team will perform the bilateral RSBs using an in-plane ultrasound-guided technique with 0.25% bupivacaine with epinephrine 1:200 000 at 0.8 mL/kg (half of total volume per side) up to a maximum of 20 mL prior to the incision. The surgical team will then use the remaining 0.2 mL/kg to infiltrate the remaining port sites in RSB groups. Intravenous Dexamethasone will be administered concurrently.

Group II: Local Anesthetic Active Control 2 Interventions

Local anesthetic at the incision site is also current standard of care for appendectomy patients and is used by providers at the British Columbia Children's Hospital. This group will receive up to a maximum of 1 mL/kg total of LA which will ensure the total volume calculation for each arm would receive a bupivacaine dose at or below 2.5 mg/kg body weight. The local anesthetic infiltration arm will receive the same local anesthetic as the rectus sheath block arm (0.25% bupivacaine with epinephrine 1:200 000), injected by the surgeon. Surgeons can inject up to a total dose of 0.8 mL/kg (maximum 20 mL) at the umbilical port site. The remaining volume of local anesthetic (0.2 mL/kg) can be infiltrated at each of the incision sites at the discretion of the surgeon.

Who Is Running the Clinical Trial?

University of British Columbia

Lead Sponsor

Trials

1,506

Recruited

2,528,000+

BC Children's Hospital Research Institute

Collaborator

Trials

14

Recruited

2,800+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06945263

Study Details | NCT06945263 | Comparing Pain Relief ... This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12482538/

Rectus sheath blocks for pediatric laparoscopic ... Conclusions. RSB can improve pain scores and reduce overall analgesic consumption in pediatric laparoscopic appendicectomies. However, RSB may ...

3. cureus.com cureus.com/articles/207879-pain-management-throughout-pediatric-laparoscopic-appendectomy-a-systematic-review

Pain Management Throughout Pediatric Laparoscopic ... Pediatric patients who underwent pre incision rectus sheath block had significantly lower opioid usage compared to those who had ...

4. researchgate.net researchgate.net/publication/395967922_Rectus_sheath_blocks_for_pediatric_laparoscopic_appendicectomy

(PDF) Rectus sheath blocks for pediatric laparoscopic ... Conclusions RSB can improve pain scores and reduce overall analgesic consumption in pediatric laparoscopic appendicectomies. However, RSB may ...

5. withpower.com withpower.com/trial/pain-relief-methods-for-laparoscopic-appendectomy-in-children-ea35c

Pain Relief Methods for Laparoscopic Appendectomy in ... Trial Overview The study compares two pain relief methods: one group receives a rectus sheath block with IV dexamethasone before being cut (RSB+dex), while the ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06945263

Study Details | NCT06945263 | Comparing Pain Relief ... This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with ...