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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.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Official record

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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
Show all 11Show fewer
  • 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.

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 groups in NCT07816055
Study groupRoleWhat they receive
Group IActive comparatorExternal Oblique Intercostal Block, EOI
Receives: Procedure: External Oblique Intercostal Block
Group IIActive comparatorPort-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.

  1. 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.

  1. First posted11 Sep 2026
  2. Study startOct 2026 (estimated)
  3. Primary completionOct 2027 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

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)
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

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