NCT07101835

Brief Summary

n obese patients, adequate pain relief in the postoperative period is a crucial parameter that affects patient comfort and hospital stay. Improving patient comfort and recovery quality can be achieved by minimizing undesirable effects such as nausea, vomiting, and inadequate analgesia. This study aimed to evaluate the impact of the external oblique intercostal block on postoperative dermatomal distribution, acute pain scores, and opioid consumption during the first 24 hours after laparoscopic sleeve gastrectomy surgery.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Aug 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

July 28, 2025

Completed
4 days until next milestone

Study Start

First participant enrolled

August 1, 2025

Completed
2 days until next milestone

First Posted

Study publicly available on registry

August 3, 2025

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2025

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

December 15, 2025

Completed
Last Updated

December 23, 2025

Status Verified

December 1, 2025

Enrollment Period

3 months

First QC Date

July 28, 2025

Last Update Submit

December 16, 2025

Conditions

Keywords

external oblique intercostal blockacute pain

Outcome Measures

Primary Outcomes (1)

  • Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Upper Abdominal Wall Following External Oblique Intercostal Block

    Participants will undergo sensory assessment using a standardized cold sensation test at 30 minutes post-block to evaluate the maximum sensory blockade. The data will be recorded as the area of sensory loss (in cm) along the anterior abdominal wall, and the results will be aggregated to report the maximum area of sensory blockade achieved with the external oblique intercostal block. Cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. A successful block is defined as a complete loss or reduction of cold sensitivity.

    30 minutes after the blocks

Secondary Outcomes (6)

  • Cumulative opioid consumption in the first 24 hours after surgery

    Postoperative Day 1

  • Acute pain scores

    Postoperative Day 1

  • The number of patients who required rescue analgesia

    Postoperative Day 1

  • The incidences of postoperative nausea and vomiting (PONV)

    Postoperative Day 1

  • The number of patients with complications

    Postoperative 7 days on an average

  • +1 more secondary outcomes

Study Arms (1)

Group EOIB

bilateral EOIB (60 ml, %0.25 bupivacaine, totally) + IV morphine patient-controlled analgesia (PCA)

Procedure: Bilateral ultrasound guided external oblique intercostal block (EOIB)Drug: ıv morphine PCA

Interventions

Bilateral ultrasound-guided EOIB (total of 60 ml, %0.25 bupivacaine) will be performed + IV morphine PCA Patients scheduled for LSG will receive a Bilateral ultrasound guided external oblique intercostal block (EOIB) preoperatively, and sensory block status will be evaluated after 30 minutes.

Also known as: EOIB
Group EOIB

ıV PCA of 0,5mg/ml morphine (the bolus dose is 20 μg/kg, the lock-in time of 6-10 minutes, the 4-hour limit is adjusted to be 80% of the calculated total amount).

Also known as: morphine PCA
Group EOIB

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

patients undergoing laparoscopic sleeve gastrectomy

You may qualify if:

  • years

You may not qualify if:

  • Patients who did not sign the informed consent form and did not wish to participate in the study
  • Patients with a history of opioid use lasting longer than four weeks
  • Patients with chronic pain
  • Patients with a history of allergy or hypersensitivity to local anesthetics or opioids
  • Presence of severe cardiac, hepatic, or renal disease
  • Patients with alcohol or drug addiction
  • Conditions contraindicating the application of regional anesthesia
  • Patients with severe psychiatric disorders such as psychosis or dementia that limit cooperation
  • Block failure identified by dermatomal examination after the procedure
  • Patients with a STOP-BANG score \> 5

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ondokuz Mayis University

Samsun, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Acute PainObesity, Morbid

Condition Hierarchy (Ancestors)

PainNeurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsObesityOverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody Weight

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assistant professor

Study Record Dates

First Submitted

July 28, 2025

First Posted

August 3, 2025

Study Start

August 1, 2025

Primary Completion

November 1, 2025

Study Completion

December 15, 2025

Last Updated

December 23, 2025

Record last verified: 2025-12

Locations