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Completed

NCT Number: NCT07678385

Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy

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.

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Key information

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Hospital Universitario de Caracas

Caracas, Miranda, 1040, Venezuela

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lidocaine (drug)

Drug

Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.

Normal Saline Placebo Infusion

Drug

Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.

Primary outcomes

  1. Postoperative pain intensity

    Time frame: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.

    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.

Secondary outcomes

  1. Total opioid comsumption

    Time frame: From surgery completion through 24 hours after surgery.

    Total postoperative opioid requirement during the first 24 hours after surgery.

  2. Post operative nausea and vomiting

    Time frame: From surgery completion through 24 hours after surgery.

    Incidence of postoperative nausea and vomiting requiring treatment

  3. Time to return of bowel function

    Time frame: From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.

    Time from surgery completion to first flatus or bowel movement.

  4. Lengh of hospital stay

    Time frame: From surgery completion until hospital discharge (anticipated within 72 hours after surgery).

    Time from surgery completion until hospital discharge.

  5. Plasma lidocaine concentration

    Time frame: 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

    Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile.

Sponsors and collaborators

Lead sponsor

Hospital Universitario de Caracas

Other

Registry information

Official study title

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

Acronym: LIDO-APP

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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