Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy (LIDO-APP)

Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial

This randomized, double-blind, placebo-controlled clinical trial evaluated whether intraoperative intravenous lidocaine infusion improves postoperative analgesia and recovery in patients undergoing laparoscopic appendectomy. The primary objective was to assess postoperative pain intensity and opioid consumption. Secondary outcomes included postoperative nausea and vomiting, time to bowel function recovery, length of hospital stay, plasma lidocaine concentrations, and adverse events.

Study Overview

• Status: Completed
• Conditions: Post Operative Pain, Acute; Laparoscopic Appendectomy
• Intervention / Treatment: Drug: Lidocaine (drug); Drug: Normal Saline Placebo Infusion

Detailed Description

Postoperative pain following laparoscopic appendectomy remains an important clinical concern despite advances in multimodal analgesia. Intravenous lidocaine has been proposed as an effective adjunct because of its analgesic, anti-inflammatory, and antihyperalgesic properties, but evidence in laparoscopic appendectomy remains limited.

This prospective, randomized, double-blind, placebo-controlled trial compared continuous intraoperative intravenous lidocaine infusion with placebo in patients undergoing laparoscopic appendectomy under standardized general anesthesia. Patients were randomly allocated to receive either lidocaine or placebo according to the study protocol.

The primary outcome was postoperative pain intensity measured using the Visual Analogue Scale (VAS). Secondary outcomes included opioid requirements, postoperative nausea and vomiting, return of bowel function, length of hospital stay, incidence of adverse events, and perioperative plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points.

The study aimed to determine the clinical efficacy and safety of intravenous lidocaine infusion as part of multimodal perioperative analgesia for laparoscopic appendectomy and to correlate analgesic effects with measured plasma lidocaine concentrations.

• Study Type: Interventional
• Enrollment (Actual): 225
• Phase: Phase 4

Contacts and Locations

Study Locations

• Venezuela
  • Miranda
    • Caracas, Miranda, Venezuela, 1040
      • Hospital Universitario de Caracas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: Yes

Description

Inclusion Criteria:

• Adults aged 18 to 45 years.
• ASA physical status I or II.
• Scheduled for laparoscopic appendectomy under general anesthesia.
• Able to provide written informed consent.

Exclusion Criteria:

• History of cardiac conduction disorders or documented arrhythmias.
• Hepatic insufficiency.
• Renal insufficiency.
• Chronic or long-term opioid therapy.
• Known or suspected hypersensitivity to amide-type local anesthetics.
• Hemodynamic instability at the time of admission to the operating room.
• Body mass index greater than 35 kg/m².

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intravenous lidocaine group; Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.	Drug: Lidocaine (drug); Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
Placebo Comparator: Placebo group; Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.	Drug: Normal Saline Placebo Infusion; Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Postoperative pain intensity	Postoperative pain intensity assessed using the Visual Analogue Scale (VAS, 0-10), where 0 indicates no pain and 10 indicates the worst imaginable pain. Lower scores indicate better analgesic efficacy.	At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Total opioid comsumption	Total postoperative opioid requirement during the first 24 hours after surgery.	From surgery completion through 24 hours after surgery.
Post operative nausea and vomiting	Incidence of postoperative nausea and vomiting requiring treatment	From surgery completion through 24 hours after surgery.
Time to return of bowel function	Time from surgery completion to first flatus or bowel movement.	From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
Lengh of hospital stay	Time from surgery completion until hospital discharge.	From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
Plasma lidocaine concentration	Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.	From baseline through 1 hour after admission to the post-anesthesia care unit (PACU), with plasma lidocaine concentrations assessed at baseline, 30 minutes after study drug infusion initiation, 90 minutes after study drug infusion initiation, and 1 hour

Collaborators and Investigators

• Sponsor: Hospital Universitario de Caracas
• Investigators: Principal Investigator: JOSEPH A VERAZA, MD, sociedad medica joseph veraza

Study record dates

Study Major Dates

• Study Start (Actual): February 1, 2024
• Primary Completion (Actual): January 1, 2025
• Study Completion (Actual): January 1, 2025

Study Registration Dates

• First Submitted: June 14, 2026
• First Submitted That Met QC Criteria: June 28, 2026
• First Posted (Actual): July 1, 2026

Study Record Updates

• Last Update Posted (Actual): July 1, 2026
• Last Update Submitted That Met QC Criteria: June 28, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Keywords: MULTI-MODAL ANALGESIA; LIDOCAINE INFUSION; POST-OPERATIVE PAIN; OPIOID SPARING; DOUBLE-BLIND TRIAL; RANDOMIZED CONTROLED TRIAL
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Pain, Postoperative; Organic Chemicals; Anilides; Amides; Aniline Compounds; Amines; Acetanilides; Lidocaine; Pharmaceutical Preparations
• Other Study ID Numbers: HUC-LIDO-APP-2024-001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: Individual participant data (IPD) will not be publicly shared. De-identified data may be made available by the corresponding author upon reasonable request and subject to institutional and ethical approval.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No