Post Operative Pain, AcutePhase 4LIDO-APPNCT07678385
Intraoperative Intravenous Lidocaine for Pain After Laparoscopic Appendectomy
A Phase 4 study testing Lidocaine (drug) in people with Post Operative Pain, Acute and Laparoscopic Appendectomy, run by Hospital Universitario de Caracas at 1 site in Venezuela.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Post Operative Pain, Acute, Laparoscopic Appendectomy
- What is being tested?
- Lidocaine (drug)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 225 participants
- Where
- 1 siteVenezuela
- Study dates
- 1 Feb 2024to 1 Jan 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
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.
Read the 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.
- Being tested
- Lidocaine (drug), Normal Saline Placebo Infusion
- Keywords
- MULTI-MODAL ANALGESIA, LIDOCAINE INFUSION, POST-OPERATIVE PAIN, OPIOID SPARING, DOUBLE-BLIND TRIAL, RANDOMIZED CONTROLED TRIAL
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine (drug)Drug
Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol.
Normal Saline Placebo InfusionDrug
Intravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding.
| Study group | Role | What they receive |
|---|---|---|
| Intravenous lidocaine group | Experimental | Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol. Receives: Drug: Lidocaine (drug) |
| Placebo group | Placebo comparator | Participants received an equivalent volume of normal saline placebo under identical anesthetic conditions. Receives: Drug: Normal Saline Placebo Infusion |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.
Secondary outcomes (5)
Total opioid comsumption
Total postoperative opioid requirement during the first 24 hours after surgery.
Measured: From surgery completion through 24 hours after surgery.
Post operative nausea and vomiting
Incidence of postoperative nausea and vomiting requiring treatment
Measured: From surgery completion through 24 hours after surgery.
Time to return of bowel function
Time from surgery completion to first flatus or bowel movement.
Measured: 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.
Measured: 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.
Measured: 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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jul 2026
- Study start1 Feb 2024
- Primary completion1 Jan 2025
- Study completion1 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Post Operative Pain, AcuteStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 225 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario de Caracas
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joseph Alejandro Veraza Almeida, Hospital Universitario de Caracas
- Investigators
- JOSEPH A VERAZA, MD, Principal investigator, sociedad medica joseph veraza
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07678385
- Sponsor's protocol ID
- HUC-LIDO-APP-2024-001
- Acronym
- LIDO-APP
- Status last verified
- Jun 2026
- First submitted
- 14 Jun 2026
- Last updated
- 1 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intraoperative Intravenous Lidocaine Infusion for Postoperative Analgesia and Recovery After Laparoscopic Appendectomy: A Randomized, Double-blind, Placebo-controlled Trial
- ClinicalTrials.gov ID
- NCT07678385
- Acronym / sponsor ID
- LIDO-APP / HUC-LIDO-APP-2024-001
- Keywords
- MULTI-MODAL ANALGESIA, LIDOCAINE INFUSION, POST-OPERATIVE PAIN, OPIOID SPARING, DOUBLE-BLIND TRIAL, RANDOMIZED CONTROLED TRIAL
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 225 participants (actual)
- Lead sponsor
- Hospital Universitario de CaracasUniversity, hospital or other
- Study start
- 1 Feb 2024 (actual)
- Primary completion
- 1 Jan 2025 (actual)
- Study completion
- 1 Jan 2025 (actual)
- First posted
- 1 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| Intravenous lidocaine group | Experimental | Drug: Lidocaine (drug)Participants received intraoperative intravenous lidocaine infusion in addition to standardized general anesthesia according to the study protocol. |
| Placebo group | Placebo comparator | Drug: Normal Saline Placebo InfusionParticipants received an equivalent volume of normal saline placebo under identical anesthetic conditions. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lidocaine (drug)Intravenous lidocaine administered as a bolus followed by continuous infusion during laparoscopic appendectomy according to the study protocol. | Drug | Intravenous lidocaine group |
| Normal Saline Placebo InfusionIntravenous isotonic saline administered using the same infusion schedule as the active treatment to maintain blinding. | Drug | Placebo group |
Primary outcome
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.
5 secondary outcomes
Total opioid comsumption
Time frame: From surgery completion through 24 hours after surgery.
Post operative nausea and vomiting
Time frame: From surgery completion through 24 hours after surgery.
Time to return of bowel function
Time frame: From surgery completion to first flatus or bowel movement, assessed through 24 hours after surgery.
Lengh of hospital stay
Time frame: From surgery completion until hospital discharge (anticipated within 72 hours after surgery).
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
JOSEPH A VERAZA, MD principal investigator
sociedad medica joseph veraza
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Lidocaine (drug) in people with Post Operative Pain, Acute and Laparoscopic Appendectomy, run by Hospital Universitario de Caracas at 1 site in Venezuela.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Venezuela. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative pain intensity (time frame: At 0 (PACU admission), 4, 8, 12, and 24 hours after surgery.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Jul 2026.