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

NCT07816055 | Not Yet Recruiting DMC

• 1 other identifier: EOIPB VS Local Analgesia LSG
• Study Type: interventional
• Target: 54
• Locations: 0 countries
• Sites: N/A

Brief 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. 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

Outcome Measures

Primary Outcomes (1)

• Total opioid consumption

  Total opioid consumption (IV NALUFIN) during the first 24 postoperative hours

  24 hours

Study Arms (2)

Group I

ACTIVE COMPARATOR

External Oblique Intercostal Block, EOI

Procedure: External Oblique Intercostal Block

Group II

ACTIVE COMPARATOR

Port-Site Local Anesthetic Infiltration

Procedure: Port-Site Local Anesthetic Infiltration

Interventions

Port-Site Local Anesthetic Infiltration PROCEDURE

patients undergoing laparoscopic sleeve gastrectomy receiving port-site infiltration with 5 ml 0.25% bupivacaine at each port site.

Group II

External Oblique Intercostal Block PROCEDURE

ultrasound-guided external oblique intercostal block with 30 ml 0.25% bupivacaine bilaterally.

Group I

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patient refusal
• Allergy to local anesthetics
• Coagulopathy
• Infection at injection site
• Chronic opioid use
• Hepatic failure
• Renal failure
• Conversion to open surgery
• OSAS-home CPAP
• Cardiac patients
• Super morbid \>50 kg / m²

Sponsors & Collaborators

• Assiut University: lead

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Resident doctor at Anesthesia, Intensive Care and Pain Management

Study Record Dates

• First Submitted: September 7, 2026
• First Posted: September 11, 2026
• Study Start: October 1, 2026
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: September 11, 2026

Record last verified: 2026-09