Clinical trial NCT03886896: Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy
Official title: Efficacy of Intravenous Lidocaine Infusion on Pain Relief in Children Undergoing Laparoscopic Appendectomy: Randomized Controlled Trial.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Acute Appendicitis
Postoperative Pain
Postoperative Nausea and Vomiting
Keywords: systemic lidocaine
nalbuphine
postoperative pain
multimodal analgesia
laparoscopic appendectomy
laparoscopy
recovery
Lead sponsor: Medical University of Warsaw
Sponsor class: OTHER
First posted: 2019-03-22
Enrollment: 74
Sex: ALL
Minimum age (years): 18
Maximum age (years): 18
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Postoperative opioid consumption
timeFrame: 24 hours after surgery
Secondary outcomes:
measure: Intraoperative opioid consumption
timeFrame: Intraoperative - from induction of anesthesia to extubation
measure: Intraoperative volatile anesthetic consumption
timeFrame: Intraoperative - from induction of anesthesia to extubation
measure: Time to first perception of significant pain
timeFrame: 24 hours after surgery
measure: Incidence of postoperative nausea and vomiting (PONV)
timeFrame: 24 hours after surgery
measure: Side effects of lidocaine will be documented
timeFrame: 24 hours after surgery
Other outcomes:
Locations:
city: Warsaw
country: Poland
facility: University Clinic Centre of Medical University of Warsaw
Study officials:
affiliation: Medical University of Warsaw
name: Maciej Kaszyński
role: PRINCIPAL_INVESTIGATOR
References:
citation: Kaszynski M, Stankiewicz B, Palko KJ, Darowski M, Pagowska-Klimek I. Impact of lidocaine on hemodynamic and respiratory parameters during laparoscopic appendectomy in children. Sci Rep. 2022 Aug 18;12(1):14038. doi: 10.1038/s41598-022-18243-3.
citation: Kaszynski M, Lewandowska D, Sawicki P, Wojcieszak P, Pagowska-Klimek I. Efficacy of intravenous lidocaine infusions for pain relief in children undergoing laparoscopic appendectomy: a randomized controlled trial. BMC Anesthesiol. 2021 Jan 5;21(1):2. doi: 10.1186/s12871-020-01218-0.