Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy

NCT07678385 | Completed Phase 4

• 1 other identifier: HUC-LIDO-APP-2024-001
• Study Type: interventional
• Target: 225
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Post Operative Pain, Acute; Laparoscopic Appendectomy

Keywords

MULTI-MODAL ANALGESIA; LIDOCAINE INFUSION; POST-OPERATIVE PAIN; OPIOID SPARING; DOUBLE-BLIND TRIAL; RANDOMIZED CONTROLED TRIAL

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• Total opioid comsumption

  From surgery completion through 24 hours after surgery.

• Post operative nausea and vomiting

  From surgery completion through 24 hours after surgery.

• Time to return of bowel function

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

• Lengh of hospital stay

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

• Plasma lidocaine concentration

  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

Study Arms (2)

Intravenous lidocaine group

EXPERIMENTAL

Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol.

Drug: Lidocaine (drug)

Placebo group

PLACEBO COMPARATOR

Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions.

Drug: Normal Saline Placebo Infusion

Interventions

Lidocaine (drug) DRUG

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

Intravenous lidocaine group

Normal Saline Placebo Infusion DRUG

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

Placebo group

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario de Caracas: lead

Study Sites (1)

Hospital Universitario de Caracas

Caracas, Miranda, 1040, Venezuela

Location

MeSH Terms

Conditions

Pain, Postoperative

Interventions

Lidocaine; Pharmaceutical Preparations

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Acetanilides; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Officials

• JOSEPH A VERAZA, MD

  sociedad medica joseph veraza

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Participants, anesthesia providers, investigators, and outcome assessors were blinded to treatment allocation throughout the study. Intravenous lidocaine and placebo solutions were prepared in identical syringes by personnel not involved in patient management or outcome assessment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Model Details: Participants were randomly assigned in a parallel-group design to receive either intravenous lidocaine infusion or placebo during laparoscopic appendectomy under standardized general anesthesia. Both groups received identical perioperative management except for the study intervention.

Study Record Dates

• First Submitted: June 14, 2026
• First Posted: July 1, 2026
• Study Start: February 1, 2024
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: July 1, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

VE (1)