Intravenous Lidocaine in Children Undergoing Laparoscopic Appendectomy

NCT ID: NCT03886896

Last Updated: 2020-05-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 74 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-03-22
• Study Completion Date: 2020-01-17

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.

Conditions

Acute Appendicitis; Postoperative Pain; Postoperative Nausea and Vomiting

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Group A - lidocaine group

Group A: children receiving standard general anesthesia with intravenous lidocaine infusion 1,5 mg/kg for 5 minutes before induction of anesthesia. After 5 minutes, lidocaine infusion continued at rate of 1.5 mg/kg/h during operation, and discontinued before move the patients to PACU.

Group Type: EXPERIMENTAL

Lidocaine

Intervention Type: DRUG

Lidocaine infusion during surgery

Group B - control group

Group B: children receiving standard general anesthesia (involving fentanyl and sevoflurane) without lidocaine infusion

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Lidocaine

Lidocaine infusion during surgery

Intervention Type: DRUG

Other Intervention Names

Intravenous lidocaine infusion

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

• Minimum Eligible Age: 18 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Medical University of Warsaw

OTHER

Sponsor Role: lead

Responsible Party

Maciej Kaszyński

Principal Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Maciej Kaszyński

Role: PRINCIPAL_INVESTIGATOR

Medical University of Warsaw

Locations

University Clinic Centre of Medical University of Warsaw

Warsaw, , Poland

Countries

Poland

References

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.

Reference Type: DERIVED

PMID: 35982198 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 33397287 (View on PubMed)

Other Identifiers

Lido01

Identifier Type: -

Identifier Source: org_study_id