Hospital Universitario de Caracas
Caracas, Miranda, 1040, Venezuela
NCT Number: NCT07678385
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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Notify Me18 year–45 year
All sexes
Interventional
Phase 4
Caracas, Miranda, 1040, Venezuela
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.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
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.
Time frame: From surgery completion through 24 hours after surgery.
Total postoperative opioid requirement during the first 24 hours after surgery.
Time frame: From surgery completion through 24 hours after surgery.
Incidence of postoperative nausea and vomiting requiring treatment
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.
Time frame: From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
Time from surgery completion until hospital discharge.
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.
Hospital Universitario de Caracas
Other
Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
Acronym: LIDO-APP
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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