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

32 Participants Needed

Trial Summary

What is the purpose of this trial?

Laparoscopic appendectomies are the most common emergency surgeries performed in children. Despite being considered minimally invasive surgeries, they can result in substantial postoperative pain and 2 of 3 patients require postoperative opioids. Increased postoperative pain can delay recovery, increase hospital admission time, lead to chronic pain, and cause patient distress. This study aims to reduce postoperative pain in this population by comparing the recovery outcomes associated with the administration of (1) an RSB with coadministration of IV dexamethasone as an LA adjunct (RSB+dex group) prior to the incision with (2) LA infiltration alone by the surgeon (LA group).

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.

What data supports the effectiveness of the treatment for pain relief in children undergoing laparoscopic appendectomy?

Research suggests that using local anesthetics at incision sites can help reduce pain after surgery. Additionally, dexmedetomidine, when used with local anesthetics, may enhance pain relief. However, more studies are needed to confirm these findings. ^{1 2 3 4 5}

Is the use of local anesthetics and intravenous dexamethasone safe for children undergoing laparoscopic appendectomy?

Research shows that using local anesthetics during laparoscopic appendectomy is generally safe and can reduce pain and nausea after surgery. However, more studies are needed to confirm these findings, especially in children. ^{1 2 3 4 6}

How does the treatment of local anesthetic at the incision and umbilical port site differ from other pain relief methods for children after laparoscopic appendectomy?

This treatment is unique because it involves applying a local anesthetic directly at the incision and umbilical port sites, which may provide targeted pain relief right where the surgery occurred. This approach differs from other methods like intravenous opioids or oral medications, which affect the whole body, and from techniques like ultrasound-guided nerve blocks that target broader areas. ^{1 3 4 7 8}

Research Team

Prakash Krishnan, MD

Principal Investigator

University of British Columbia

Eligibility Criteria

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.

Patients with steroid dependence

Timeline

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

Treatment Details

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.

Participant Groups

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+

References

1. France pubmed.ncbi.nlm.nih.gov

A retrospective study of multimodal analgesic treatment after laparoscopic appendectomy in children. [2014]

2. Korea (South) pubmed.ncbi.nlm.nih.gov

The role of port site local anesthetic injection in laparoendoscopic single site surgery: a prospective randomized study. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Intraperitoneal Local Anesthetic for Laparoscopic Appendectomy in Children: A Randomized Controlled Trial. [2022]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Postoperative Pain Management in Children Undergoing Laparoscopic Appendectomy: A Scoping Review. [2023]

5. Canada pubmed.ncbi.nlm.nih.gov

Is wound infiltration with anesthetic effective as pre-emptive analgesia? A clinical trial in appendectomy patients. [2014]

6. England pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Intraperitoneal Local Anesthetics in Laparoscopic Appendectomy: A Systematic Review and Meta-Analysis. [2020]

7. India pubmed.ncbi.nlm.nih.gov

Intraperitoneal dexmedetomidine as an adjuvant to bupivacaine for postoperative pain management in children undergoing laparoscopic appendectomy: A prospective randomized trial. [2022]

8. England pubmed.ncbi.nlm.nih.gov

Ultrasound-guided transversus abdominis plane blocks for laparoscopic appendicectomy in children: a prospective randomized trial. [2022]