Laparoscopic Appendectomy, Post Operative Pain, Acute
Conditions
Keywords
MULTI-MODAL ANALGESIA, LIDOCAINE INFUSION, POST-OPERATIVE PAIN, OPIOID SPARING, DOUBLE-BLIND TRIAL, RANDOMIZED CONTROLED TRIAL
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.
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.
Interventions
DRUGLidocaine (drug)
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.
Sponsors
Hospital Universitario de Caracas
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
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.
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Postoperative pain intensity | 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
| Measure | Time frame | Description |
|---|---|---|
| Total opioid comsumption | From surgery completion through 24 hours after surgery. | Total postoperative opioid requirement during the first 24 hours after surgery. |
| Post operative nausea and vomiting | From surgery completion through 24 hours after surgery. | Incidence of postoperative nausea and vomiting requiring treatment |
| Time to return of bowel function | 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. |
| Lengh of hospital stay | From surgery completion until hospital discharge (anticipated within 72 hours after surgery). | Time from surgery completion until hospital discharge. |
| 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 | Plasma lidocaine concentrations measured at predefined intraoperative and postoperative time points to evaluate systemic exposure and pharmacokinetic profile. |
Countries
Venezuela
Contacts
PRINCIPAL_INVESTIGATORJOSEPH A VERAZA, MD
sociedad medica joseph veraza
Outcome results
None listed