Obese PatientsNCT07809425
External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery
A study testing Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption. and Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). in people with Obese Patients, run by Menoufia University at 1 site in Egypt.
Trial summary
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Obese Patients
- What is being tested?
- Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption. and Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Sep 2026to 1 Feb 2027
- Phase
- Interventional
- 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
- Age 18-60 years.
- BMI ≥ 35 kg/m².
- ASA physical status II or III.
- Scheduled for elective laparoscopic Roux en Y gastric bypass.
- Ability to provide written informed consent.
Who cannot join
- Refusal.
- Allergy or contraindication to lidocaine, fentanyl, ropivacaine, or any study medication.
- Chronic opioid use or dependence.
- Significant hepatic (AST/ALT> 3× normal, cirrhosis) or renal impairment (CrCl< 30 mL/min).
- Second or third degree AV block or significant bradyarrhythmia without pacemaker.
- Coagulopathy, anticoagulation incompatible with regional anesthesia, or infection at block site.
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- Pregnancy or lactation.
- Severe psychiatric or cognitive disorder.
- Failed bilateral EOIB (absence of sensory loss in T6-T10 after 30 min) - excluded from analysis.
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, 1 recruiting
- Recruiting
Faculty of Medicine
Alexandria
Nevine Mostafa Soliman, +201128861471, mostafanevine@gmail.com
About this study
Official title: External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery: a Randomized Controlled Trial
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events.
- Conditions
- Obese Patients
- Being tested
- Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption., Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption.Drug
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events.
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).Other
Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).
| Study group | Role | What they receive |
|---|---|---|
| Group L (lidocaine) | Active comparator | Bilateral EOIB + fentanyl 1 μg/kg loading + lidocaine 1.5 mg/kg loading + lidocaine infusion 1.5 mg/kg/h. Receives: Drug: Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption. |
| Group P (placebo) | Placebo comparator | Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). Receives: Other: Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total intraoperative fentanyl consumption
Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.
Measured: Intraoperative time, during surgery
Secondary outcomes (3)
Postoperative morphine consumption
Postoperative morphine consumption (mg) at 24 hours.
Measured: The first 24 hours
First rescue fentanyl and time to first postoperative morphine
Time to first rescue fentanyl (from induction to first bolus) and Time to first postoperative morphine (from PACU arrival to first dose).
Measured: The first 24 hours
Pain scores
Pain scores (VAS score ranging 0-100) at Post Anesthetic Care Unit arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.
Measured: Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 hours.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2026
- Study start15 Sep 2026 (estimated)
- Primary completion15 Jan 2027 (estimated)
- Study completion1 Feb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obese PatientsStudies of the same condition, open and under way.
- More trials run by Menoufia 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Menoufia University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nevine Mostafa Soliman, Menoufia University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07809425
- Sponsor's protocol ID
- 8/2026ANET3
- Status last verified
- Aug 2026
- First submitted
- 30 Aug 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 11 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Block With or Without Intravenous Lidocaine Infusion for Analgesia in Patients Undergoing Gastric Bypass Surgery: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07809425
- Acronym / sponsor ID
- 8/2026ANET3
- Conditions
- Obese Patients
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Menoufia UniversityUniversity, hospital or other
- Study start
- 15 Sep 2026 (estimated)
- Primary completion
- 15 Jan 2027 (estimated)
- Study completion
- 1 Feb 2027 (estimated)
- First posted
- 9 Sep 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.
Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group L (lidocaine) | Active comparator | Drug: Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption.Bilateral EOIB + fentanyl 1 μg/kg loading + lidocaine 1.5 mg/kg loading + lidocaine infusion 1.5 mg/kg/h. |
| Group P (placebo) | Placebo comparator | Other: Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years.
- BMI ≥ 35 kg/m².
- ASA physical status II or III.
- Scheduled for elective laparoscopic Roux en Y gastric bypass.
- Ability to provide written informed consent.
Key exclusion criteria (9 listed)
- Refusal.
- Allergy or contraindication to lidocaine, fentanyl, ropivacaine, or any study medication.
- Chronic opioid use or dependence.
- Significant hepatic (AST/ALT> 3× normal, cirrhosis) or renal impairment (CrCl< 30 mL/min).
- Second or third degree AV block or significant bradyarrhythmia without pacemaker.
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 |
|---|---|---|
| Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption.Adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption (ANI guided rescue) compared to placebo, without increasing adverse events. | Drug | Group L (lidocaine) |
| Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate).Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). | Other | Group P (placebo) |
Primary outcome
Total intraoperative fentanyl consumption
Time frame: Intraoperative time, during surgery
Total intraoperative fentanyl consumption (μg) = loading dose (1 μg/kg) + rescue boluses.
3 secondary outcomes
Postoperative morphine consumption
Time frame: The first 24 hours
First rescue fentanyl and time to first postoperative morphine
Time frame: The first 24 hours
Pain scores
Time frame: Upon arrival, 1 hour, 2 hours, 6 hours, 12 hours, 24 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 11 Sep 2026.
- Individual participant dataSharing planned: Undecided
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Investigatore hypothesize that adding a perioperative lidocaine infusion (1.5 mg/kg loading + 1.5 mg/kg/h) to bilateral EOIB and low dose fentanyl loading reduces intraoperative fentanyl consumption. and Bilateral EOIB + fentanyl 1 μg/kg loading + normal saline loading (equivalent volume) + normal saline infusion (equivalent rate). in people with Obese Patients, run by Menoufia 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 5 inclusion and 9 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: looking for participants now, as of the sponsor's last update on 11 Sep 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 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.
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 Nevine Mostafa Soliman (+201128861471, mostafanevine@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total intraoperative fentanyl consumption (time frame: Intraoperative time, during 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 11 Sep 2026.