Enhanced Recovery After AnesthesiaPhase 2/3IVNCT07150481
Intraoperative Lidocaine Infusion
A Phase 2/3 study testing IV Lidocaine infusion and IV normal saline in people with Enhanced Recovery After Anesthesia, run by Assiut University at 1 site in Egypt.
Trial summary
This study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Enhanced Recovery After Anesthesia
- What is being tested?
- IV Lidocaine infusion and IV normal saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteEgypt
- Study dates
- Oct 2025to Mar 2027
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Patients aged 18 - 60 years
- Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
- ASA physical status I-II
- BMI < 35 kg/m2
- Preoperative CRP <20 mg/L
- Informed consent provided
Who cannot join
- Acute cholecystitis or biliary pancreatitis
- Conversion to open surgery
- Pre-op CRP >20 mg/L
- Allergy to lidocaine or local anesthetics
- Known hepatic or renal dysfunction
- Chronic inflammatory conditions
Show all 11Show fewer
- Current immunosuppressive therapy
- Cardiac arrhythmias or heart block without pacemaker
- ASA physical status III, IV or above
- Pregnancy or breastfeeding
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Assiut university main hospital
Asyut, Assiut Governorate, Egypt,, 71515
Noha Y Mohammed, MD, 01001890194 ext. +2, noha.hagagy@gmail.com
Afaf R Youssef, MBBCH, 01207787689 ext. +2, aymansamaan214@gmail.com
About this study
Official title: Effect of Intravenous Lidocaine Infusion on Postoperative Inflammatory Response in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Double Blind Controlled Clinical Trial
This study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy.
Read the detailed description
Laparoscopic cholecystectomy is considered a minimally invasive procedure; however, it still provokes a measurable systemic inflammatory response. This reaction is primarily driven by factors such as tissue manipulation, peritoneal insufflation, and surgical stress. C-reactive protein (CRP), a widely validated acute-phase reactant, serves as a reliable biomarker to monitor postoperative inflammation, typically peaking within 24 to 48 hours following surgery. Other inflammatory markers such as white blood cell (WBC) count, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6 (IL-6) also exhibit perioperative changes, reflecting the underlying cytokine-mediated stress response. Monitoring these biomarkers provides insight into the extent of tissue injury and can help predict postoperative recovery or complications. Therefore, modulating the inflammatory response-such as through intravenous lidocaine infusion-may improve postoperative outcomes, including pain control, gastrointestinal recovery, and length of hospital stay.
- Conditions
- Enhanced Recovery After Anesthesia
- Being tested
- IV Lidocaine infusion, IV normal saline
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IV Lidocaine infusionDrug
2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure
IV normal salineDrug
IV normal saline 0.9% , rate 50 ml/h
| Study group | Role | What they receive |
|---|---|---|
| Group L | Active comparator | IV Lidocaine infusion: Receives: Drug: IV Lidocaine infusion |
| Group C | Placebo comparator | IV normal saline Receives: Drug: IV normal saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative CRP level
measurement of Postoperative CRP level
Measured: postoperative day 1 (24 hours postoperative)
Secondary outcomes (4)
Pain scores (VNS)
verbal numerical scale from 0-10. (0 = no pain, 10 = worst imaginable pain The patient verbally reports the number that best reflects their pain intensity.
Measured: 2, 6, 12, 24 hours
GIT motility
Time to first pass of faeces or flatus/bowel movement
Measured: within 24 hours
Postoperative complications
nausea, vomiting, ileus, infection
Measured: within 48 hours
Time to ambulation
time of patient discharge from the hospital
Measured: within 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Sep 2025
- Study startOct 2025 (estimated)
- Primary completionDec 2026 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Enhanced Recovery After AnesthesiaStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Noha Yahia Mohammd El-hagagy, Assiut University
- Investigators
- Noha Y Mohamed, MD, Principal investigator, Lecturer in anesthesia and intensive care department, faculty of medicine,Noha Y Mohammed, MD, Principal investigator, Lecturer in anesthesia and intensive care department, faculty of medicine,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07150481
- Sponsor's protocol ID
- Afaf Radi
- Acronym
- IV
- Status last verified
- Aug 2025
- First submitted
- 25 Aug 2025
- Last updated
- 2 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Intravenous Lidocaine Infusion on Postoperative Inflammatory Response in Patients Undergoing Laparoscopic Cholecystectomy: A Randomized Double Blind Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07150481
- Acronym / sponsor ID
- IV / Afaf Radi
- Conditions
- Enhanced Recovery After Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- Oct 2025 (estimated)
- Primary completion
- Dec 2026 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 2 Sep 2025 (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 study aims to evaluate the analgesic and anti-inflammatory effect of perioperative intravenous lidocaine infusion and in turn the return of gastric motility in patients undergoing elective laparoscopic cholecystectomy.
Detailed description
Laparoscopic cholecystectomy is considered a minimally invasive procedure; however, it still provokes a measurable systemic inflammatory response. This reaction is primarily driven by factors such as tissue manipulation, peritoneal insufflation, and surgical stress. C-reactive protein (CRP), a widely validated acute-phase reactant, serves as a reliable biomarker to monitor postoperative inflammation, typically peaking within 24 to 48 hours following surgery. Other inflammatory markers such as white blood cell (WBC) count, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6 (IL-6) also exhibit perioperative changes, reflecting the underlying cytokine-mediated stress response. Monitoring these biomarkers provides insight into the extent of tissue injury and can help predict postoperative recovery or complications. Therefore, modulating the inflammatory response-such as through intravenous lidocaine infusion-may improve postoperative outcomes, including pain control, gastrointestinal recovery, and length of hospital stay.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- group L: lidocaine IV infusion group C: normal saline 0.9% IV infusion
| Arm | Type | Receives |
|---|---|---|
| Group L | Active comparator | Drug: IV Lidocaine infusionIV Lidocaine infusion: |
| Group C | Placebo comparator | Drug: IV normal salineIV normal saline |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Patients aged 18 - 60 years
- Elective laparoscopic cholecystectomy for symptomatic cholelithiasis or chronic cholecystitis
- ASA physical status I-II
- BMI < 35 kg/m2
- Preoperative CRP <20 mg/L
Key exclusion criteria (11 listed)
- Acute cholecystitis or biliary pancreatitis
- Conversion to open surgery
- Pre-op CRP >20 mg/L
- Allergy to lidocaine or local anesthetics
- Known hepatic or renal dysfunction
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 |
|---|---|---|
| IV Lidocaine infusion2 mg/kg/h (the total dose of lidocaine per hour will be calculated and add to normal saline 0.9% to total volume 50 ml and infused by a rate 50 ml/h till the end of the procedure | Drug | Group L |
| IV normal salineIV normal saline 0.9% , rate 50 ml/h | Drug | Group C |
Primary outcome
Postoperative CRP level
Time frame: postoperative day 1 (24 hours postoperative)
measurement of Postoperative CRP level
4 secondary outcomes
Pain scores (VNS)
Time frame: 2, 6, 12, 24 hours
GIT motility
Time frame: within 24 hours
Postoperative complications
Time frame: within 48 hours
Time to ambulation
Time frame: within 48 hours
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Enhanced Recovery After Anesthesia
Enrolling by invitation
Long-term Follow-up of Bio-signals and Quality of Recovery Following Implementation of ERAS Based on the Mobile Application
Gynecologic Surgery, General Anesthesia
Recruiting
Maltodextrin Versus Sugar Water Carbohydrate Loading and Gastric Volume in Geriatric Lower Limb Orthopedic Surgery
Respiratory Aspiration, Hyperglycemia
RecruitingPhase 4
Tranexamic Acid for Bleeding Reduction During TURP Surgery
Benign Prostatic Hyperplasia, Transurethral Resection of the Prostate
RecruitingPhase 4
Intravenous Dexamethasone With Single-Shot Versus Continuous Brachial Plexus Block for Rebound Pain After Shoulder Surgery
Pain, Postoperative, Rebound Pain
Not yet recruiting
Intraoperative Infusion of Dexmedetomidine Versus Lidocaine or Magnesium Sulphate for Enhanced Quality of Recovery After Spine Surgery Fixation
Opioid Free Anesthesia, Opioid Based Anesthesia
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.
Noha Y Mohamed, MD principal investigator
Lecturer in anesthesia and intensive care department, faculty of medicine,
Noha Y Mohammed, MD principal investigator
Lecturer in anesthesia and intensive care department, faculty of medicine,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing IV Lidocaine infusion and IV normal saline in people with Enhanced Recovery After Anesthesia, run by Assiut University at 1 site in Egypt.
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 6 inclusion and 11 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: opening soon, as of the sponsor's last update on 2 Sep 2025. 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 Egypt. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Noha Y Mohammed, MD (+201001890194, noha.hagagy@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative CRP level (time frame: postoperative day 1 (24 hours postoperative)). 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 2 Sep 2025.