Laparoscopic Sleeve GastrectomyNCT07816055
Efficacy of Ultrasound-guided External Oblique Intercostal Plane Block Versus Port-site Local Anesthetic Infiltration for Postoperative Analgesia and Pulmonary Function After Laparoscopic Sleeve Gastrectomy
A study testing Port-Site Local Anesthetic Infiltration and External Oblique Intercostal Block in people with Laparoscopic Sleeve Gastrectomy, run by Assiut University.
Trial summary
Obesity poses severe global health risks and induces complex cardiorespiratory alterations, making perioperative care critical. For patients with morbid obesity, Laparoscopic Sleeve Gastrectomy (LSG) is the most effective long-term treatment. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Sleeve Gastrectomy
- What is being tested?
- Port-Site Local Anesthetic Infiltration and External Oblique Intercostal Block
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Dec 2027
- Phase
- Interventional
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
- • Age 18-65 years
- BMI between 35 kg/m2 and 40 kg/m²
- ASA (I-II-III)
- Elective laparoscopic sleeve gastrectomy
- Ability to provide informed consent
Who cannot join
- • Patient refusal
- Allergy to local anesthetics
- Coagulopathy
- Infection at injection site
- Chronic opioid use
- Hepatic failure
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- Renal failure
- Conversion to open surgery
- OSAS-home CPAP
- Cardiac patients
- Super morbid >50 kg / m²
About this study
Obesity poses severe global health risks and induces complex cardiorespiratory alterations, making perioperative care critical. For patients with morbid obesity, Laparoscopic Sleeve Gastrectomy (LSG) is the most effective long-term treatment. However, despite being minimally invasive, LSG causes significant early postoperative pain from trocar insertion, pneumo-peritoneum, and visceral trauma. Uncontrolled pain can lead to impaired respiratory function, delayed recovery, and increased opioid-related side effects. Enhanced Recovery After Surgery (ERAS) protocols emphasize opioid-sparing multimodal analgesia. While local port-site infiltration is inexpensive and simple, its effects are localized and short-lived, often requiring supplemental opioids. In contrast, the ultrasound-guided External Oblique Intercostal (EOI) block targets the fascial plane between the external oblique and intercostal muscles (T6-T10). It provides superficial, easily identifiable landmarks in obese patients and delivers widespread sensory blockade across the upper anterior abdominal wall. To evaluate superior pain management strategies, a prospective, randomized, controlled study compares the analgesic efficacy of ultrasound-guided bilateral EOI block versus conventional port-site local anesthetic infiltration in patients undergoing elective LSG. Key Study Metrics (First 24 Postoperative Hours) Primary Outcomes: Total postoperative opioid consumption and pain scores. Secondary Outcomes: Time to first rescue analgesia, incidence of postoperative nausea and vomiting (PONV), overall patient satisfaction, and recovery metrics. Ultimately, demonstrating the superior efficacy of the EOI block over port-site infiltration may refine perioperative analgesic protocols, reduce opioid dependence, and improve recovery outcomes in bariatric surgery.
- Conditions
- Laparoscopic Sleeve Gastrectomy
- Being tested
- Port-Site Local Anesthetic Infiltration, External Oblique Intercostal Block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Port-Site Local Anesthetic InfiltrationProcedure or surgery
patients undergoing laparoscopic sleeve gastrectomy receiving port-site infiltration with 5 ml 0.25% bupivacaine at each port site.
External Oblique Intercostal BlockProcedure or surgery
ultrasound-guided external oblique intercostal block with 30 ml 0.25% bupivacaine bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| Group I | Active comparator | External Oblique Intercostal Block, EOI Receives: Procedure: External Oblique Intercostal Block |
| Group II | Active comparator | Port-Site Local Anesthetic Infiltration Receives: Procedure: Port-Site Local Anesthetic Infiltration |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Total opioid consumption (IV NALUFIN) during the first 24 postoperative hours
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2026
- Study startOct 2026 (estimated)
- Primary completionOct 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic Sleeve GastrectomyStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 54 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hazem Samir Mohamed Ahmed, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07816055
- Sponsor's protocol ID
- EOIPB VS Local Analgesia LSG
- Status last verified
- Sep 2026
- First submitted
- 7 Sep 2026
- Last updated
- 11 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No