A Phase 4 interventional study of Lidocaine (drug) and Normal Saline Placebo Infusion in Post Operative Pain, Acute and Laparoscopic Appendectomy, sponsored by Hospital Universitario de Caracas. Completed at 1 site in Venezuela. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-01.
Sponsored by Hospital Universitario de Caracas · Phase 4, Interventional, and Treatment
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.
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.
Exclusion Criteria:
Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.
Drug: Lidocaine (drug)
Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.
Drug: Normal Saline Placebo Infusion
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.
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.
Time frame: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
Total opioid comsumption
Total postoperative opioid requirement during the first 24 hours after surgery.
Time frame: From surgery completion through 24 hours after surgery.
Post operative nausea and vomiting
Incidence of postoperative nausea and vomiting requiring treatment
Time frame: From surgery completion through 24 hours after surgery.
Time to return of bowel function
Time from surgery completion to first flatus or bowel movement.
Time frame: 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.
Time frame: 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.
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
Plan to share: No — 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.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario de Caracas