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EOIB for Laparoscopic Sleeve Gastrectomy

Extent of Sensory Blockade After External Oblique Intercostal Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT07101835
Enrollment
20
Registered
2025-08-03
Start date
2025-08-01
Completion date
2025-12-15
Last updated
2025-12-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pain, Morbid Obesity, Regional Anesthesia

Keywords

external oblique intercostal block, acute pain

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.

Detailed description

In this observational study, patients undergoing laparoscopic sleeve gastrectomy who received either superficial or deep parasternal intercostal plane blocks were evaluated for sensory distribution. Sensory assessment was conducted by a blinded investigator 30 minutes after block administration. Cold sensation testing was performed using small ice tubes applied to the abdominal wall. Sensations were categorized as Normal, Reduced, or No cold. A successful block was defined as the loss or reduction of cold sensitivity within the expected dermatomal distribution, whereas a normal cold sensation was considered block failure. Assessments began at the midline, including the epigastric region and trocar insertion sites, and progressed laterally toward the anterior axillary line. The extent of sensory coverage was recorded on the skin surface, and marked dermatomal areas were subsequently subjected to digital analysis. To evaluate block duration, regression of sensory changes was reassessed at 12 and 24 hours postoperatively using the same cold sensation criteria.

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.

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).

Sponsors

Ondokuz Mayıs University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No

Inclusion criteria

* 18-65 years

Exclusion criteria

* 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

Design outcomes

Primary

MeasureTime frameDescription
Extent of Sensory Blockade Measured by Cold Sensation Testing Across the Upper Abdominal Wall Following External Oblique Intercostal Block30 minutes after the blocksParticipants 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.

Secondary

MeasureTime frameDescription
Acute pain scoresPostoperative Day 1Pain at rest and while coughing will be assessed by numerical rating scale (NRS) scores at 0, 3, 6, 12, 18, and 24 hours after extubation. The NRS is an 11-point numeric scale that ranges from 0 to 10. The NRS is an 11-point scale consisting of integers from 0 to 10: 0 indicates no pain and 10 indicates the worst pain ever possible. One day before the surgery, all patients will be informed about NRS and instructed on how to use a patient-controlled analgesia device.
The number of patients who required rescue analgesiaPostoperative Day 1The number of patients requiring rescue analgesics will be recorded over 24 hours.
Cumulative opioid consumption in the first 24 hours after surgeryPostoperative Day 1The secondary outcome will be defined as cumulative opioid consumption during the first 12 hours following surgery, calculated in intravenous morphine milligram equivalents (IV-MME). This will include both PCA-administered morphine and rescue intravenous tramadol, in accordance with the standardized ESAIC conversion guidelines. Patients may request opioids using a PCA device when their NRS score is ≥ 4.
The number of patients with complicationsPostoperative 7 days on an averageThe number of patients has any complications -directly related to the block or the drug used in the block- will be recorded
Regression of Sensory Blockade at 12 and 24 Hours Post-BlockPostoperative Day 1Block regression will be evaluated at 12 and 24 hours after block administration using cold sensation testing with ice tubes. The cold sensation will be categorized as Normal Cold, Reduced Cold, or No Cold Sensation. Participants who report Normal Cold sensation will be considered to have experienced block regression.
The incidences of postoperative nausea and vomiting (PONV)Postoperative Day 1The severity of postoperative nausea and vomiting (PONV) will be assessed using a descriptive verbal rating scale at 0, 3, 6, 12, 18, and 24 hours after extubation. If a score of 3 or more, ondansetron 4 mg IV will be administered and will repeat after 8 hours if required. The PONV scale is 0 = no nausea; 1 = slight nausea; 2 = moderate nausea; 3 = vomiting once; and 4 = vomiting more than once.

Countries

Turkey (Türkiye)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026