Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

Postoperative Pain Clinical Trial

Official title:

Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03886896
• Other study ID #: Lido01
• Status: Completed
• Phase: Phase 4
• Start date: March 22, 2019
• Est. completion date: January 17, 2020

Study information

• Verified date: May 2020
• Source: Medical University of Warsaw
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Intravenous lidocaine - a potent local anesthetic with analgesic and anti-inflammatory properties has been shown to be an effective adjunct that reduces intra and postoperative opioid consumption and facilitates pain management in adults. In children population promising but limited evidence is available. The study was planned to evaluate the efficacy of continuous intravenous infusion of lidocaine to reduce opioid consumption during and after laparoscopic appendectomy in children.

Description:

Postoperative pain in children is still one of the most under diagnosed and under treated medical problems. It affects post-surgery recovery, mortality and morbidity, limits mobility. Untreated pain not only causes child's suffering but can decrease the pain threshold in the future or lead to the development of chronic pain. Postoperative analgesia has been traditionally based on opioids but as their use can be associated with adverse effects prolonging hospital stay and affecting recovery current guidelines focus on multimodal approaches involving numerous analgesics with different mechanism of action. Growing evidence suggests that intravenous lidocaine reduces intra- and postoperative requirement for opioids. Lidocaine has been proved to have analgesic and anti-inflammatory properties. It is also a potent peripheral nervous system modulator inhibiting peripheral and central sensitization. The studies performed in adult population have proved the efficacy of systemic lidocaine in postoperative pain treatment. It is an effective adjunct that reduces opioids consumption and facilitates pain management. As such lidocaine infusion has been included in postoperative pain management guidelines for adults. Studies on children population have promising results but high quality randomized controlled trials are still missing.

The proposed study has been planned to evaluate the efficacy of continuous infusion of lidocaine as an adjunct to standard general anesthesia (involving fentanyl and sevoflurane) in reducing opioids consumption and facilitating postoperative pain control in children undergoing laparoscopic appendectomy.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 74
• Est. completion date: January 17, 2020
• Est. primary completion date: January 15, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Months to 18 Years

Eligibility

Inclusion Criteria:

1. Age between 18 months and 18 year-old

2. Patients with American Society of Anaesthesiologists physical status (ASA) class 1/1E, 2/2E, 3/3E

3. Patients undergoing laparoscopic appendectomy

Exclusion Criteria:

1. Allergy to local anesthetics or contraindication to use of lidocaine

2. Patients with American Society of Anaesthesiologists physical status (ASA) IV or more.

3. Severe cardiovascular disease

4. Preoperative bradycardia

5. Preoperative atrioventricular block

6. Renal failure

7. Chronic treatment with analgesics

8. Parents' refusal

Related Conditions & MeSH terms

• Acute Appendicitis
• Appendicitis
• Pain, Postoperative
• Postoperative Nausea and Vomiting
• Postoperative Pain
• Vomiting

Intervention

Drug:
• Lidocaine
Lidocaine infusion during surgery

Locations

Country	Name	City	State
Poland	University Clinic Centre of Medical University of Warsaw	Warsaw

Sponsors (1)

Lead Sponsor	Collaborator
Medical University of Warsaw

Country where clinical trial is conducted

Poland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative opioid consumption	Total nalbuphine requirement in milligrams during the first 24 hours after surgery	24 hours after surgery
Secondary	Intraoperative opioid consumption	Intraoperative fentanyl consumption - amount of fentanyl in micrograms/kilogram participant`s body weight	Intraoperative - from induction of anesthesia to extubation
Secondary	Intraoperative volatile anesthetic consumption	Intraoperative sevoflurane consumption in milliliters. Investigators use a standard protocol of fresh gas flow.	Intraoperative - from induction of anesthesia to extubation
Secondary	Time to first perception of significant pain	Time to first dose of nalbuphine - pain score > 3 points. Assessing Face - Legs - Activity - Crying - Consolability Scale/Numerical Rating Scale/Visual Analog Pain Scale depending on participant`s age.	24 hours after surgery
Secondary	Incidence of postoperative nausea and vomiting (PONV)	Evaluated on a four-point ordinal scale. 0 = none, 1 = nausea, 2 = vomiting 1/hr, 3 = vomiting > 1/hr	24 hours after surgery
Secondary	Side effects of lidocaine will be documented	Number of Participants with: headedness, tinnitus, perioral numbness, arrythmia.	24 hours after surgery