Analgesia After Laparoscopic CholecystectomyNCT07750769
Opioid-Free Analgesia for Laparoscopic Cholecystectomy
A study testing EOI with OFA and OFA in people with Analgesia After Laparoscopic Cholecystectomy, run by Assiut University.
Trial summary
laparoscopic cholecystectomy (LC) is often accompanied by moderate-to-severe postoperative pain. opioid-free anesthesia (OFA) consists of a variety of non-opioid narcotic drugs and techniques. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia After Laparoscopic Cholecystectomy
- What is being tested?
- EOI with OFA and OFA
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- 15 Oct 2026to 15 Oct 2028
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients scheduled for elective laparoscopic cholecystectomy (LC) surgery under general anesthesia, American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 65 years old of either sex
Who cannot join
- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or known allergy to amide local anesthetics)
- Pregnancy or breastfeeding women
- Body mass index (BMI) > 35 Kg/m2
- History of hepatic, renal, or cardiac disease
- Chronic opioid use, or history of chronic pain (pain present for more than 6 months)
- Thoracic deformity
- Neuropsychiatric disorders
- Patient refusal.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Analgesic Efficacy of Opioid-Free Anesthesia Protocol Combined With Ultrasound-Guided External Oblique Intercostal Plane Block for Laparoscopic Cholecystectomy: A Prospective Randomized Comparative Study
laparoscopic cholecystectomy (LC) is often accompanied by moderate-to-severe postoperative pain. opioid-free anesthesia (OFA) consists of a variety of non-opioid narcotic drugs and techniques.
Read the detailed description
opioid-free anesthesia (OFA) can control postoperative pain effectively and reduce opioid drug consumption.
The external oblique intercostal plane (EOI) block is easy to perform and may provide effective analgesia for laparoscopic cholecystectomy.
- Being tested
- EOI with OFA, OFA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOI with OFAProcedure or surgery
Patients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol
OFADrug
Patients will receive an opioid-free anesthesia (OFA) protocol
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | Patients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol Receives: Procedure: EOI with OFA |
| Group II | Placebo comparator | Patients will receive an opioid-free anesthesia (OFA) protocol Receives: Drug: OFA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia
Assessed in microgram
Measured: The first six hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2026
- Study start15 Oct 2026 (estimated)
- Primary completion15 Oct 2028 (estimated)
- Study completion15 Oct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Analgesia After Laparoscopic CholecystectomyStudies 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 N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham Seham Moeen, M.D., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07750769
- Sponsor's protocol ID
- SM82026
- Status last verified
- Aug 2026
- First submitted
- 2 Aug 2026
- Last updated
- 6 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Opioid-Free Anesthesia Protocol Combined With Ultrasound-Guided External Oblique Intercostal Plane Block for Laparoscopic Cholecystectomy: A Prospective Randomized Comparative Study
- ClinicalTrials.gov ID
- NCT07750769
- Acronym / sponsor ID
- SM82026
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 15 Oct 2026 (estimated)
- Primary completion
- 15 Oct 2028 (estimated)
- Study completion
- 15 Oct 2028 (estimated)
- First posted
- 6 Aug 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.
laparoscopic cholecystectomy (LC) is often accompanied by moderate-to-severe postoperative pain. opioid-free anesthesia (OFA) consists of a variety of non-opioid narcotic drugs and techniques.
Detailed description
opioid-free anesthesia (OFA) can control postoperative pain effectively and reduce opioid drug consumption.
The external oblique intercostal plane (EOI) block is easy to perform and may provide effective analgesia for laparoscopic cholecystectomy.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group I | Active comparator | Procedure: EOI with OFAPatients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol |
| Group II | Placebo comparator | Drug: OFAPatients will receive an opioid-free anesthesia (OFA) protocol |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients scheduled for elective laparoscopic cholecystectomy (LC) surgery under general anesthesia, American Society of Anesthesiologists (ASA) physical status I-II, aged from 18 to 65 years old of either sex
Key exclusion criteria (8 listed)
- Contraindications to regional block (coagulopathy, infection at the needle insertion site, or known allergy to amide local anesthetics)
- Pregnancy or breastfeeding women
- Body mass index (BMI) > 35 Kg/m2
- History of hepatic, renal, or cardiac disease
- Chronic opioid use, or history of chronic pain (pain present for more than 6 months)
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 |
|---|---|---|
| EOI with OFAPatients will receive ultrasound-guided external oblique intercostal plane (EOI) block added to an opioid-free anesthesia (OFA) protocol | Procedure or surgery | Group I |
| OFAPatients will receive an opioid-free anesthesia (OFA) protocol | Drug | Group II |
Primary outcome
the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia
Time frame: The first six hours after surgery
Assessed in microgram
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 6 Aug 2026.
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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.
Seham Seham Moeen, M.D. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing EOI with OFA and OFA in people with Analgesia After Laparoscopic Cholecystectomy, run by Assiut University.
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 1 inclusion and 8 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 6 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Seham M Moeen, M.D. (01006386324 ext. 02, seham.moeen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the amount of fentanyl consumption used for pain relief in the first six hours after laparoscopic cholecystectomy (LC) under general anesthesia (time frame: The first six 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 6 Aug 2026.