NCT07445854

Brief Summary

This prospective observational study aims to evaluate and compare the sensory block distribution and regression patterns of two regional anesthesia techniques - External Oblique Plane Block (EOPB) and Serratus Intercostal Plane Block (SIPB) - in patients undergoing laparoscopic cholecystectomy. Thirty adult patients (ASA I-III, BMI ≤ 35 kg/m², ≥50 kg) scheduled for elective laparoscopic cholecystectomy procedures will be included, with 20 in each block group. Sensory block areas will be assessed using pinprick test, and dermatomal mapping will visualize the spread. The findings are expected to improve understanding of block behavior and guide multimodal analgesia strategies in laparoscopic cholecystectomy.

Trial Health

77
On Track

Trial Health Score

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

Enrollment
40

participants targeted

Target at P25-P50 for all trials

Timeline
2mo left

Started Nov 2025

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

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

Study Progress77%
Nov 2025Jun 2026

Study Start

First participant enrolled

November 15, 2025

Completed
6 days until next milestone

First Submitted

Initial submission to the registry

November 21, 2025

Completed
3 months until next milestone

First Posted

Study publicly available on registry

March 3, 2026

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2026

Expected
17 days until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

March 3, 2026

Status Verified

February 1, 2026

Enrollment Period

6 months

First QC Date

November 21, 2025

Last Update Submit

February 25, 2026

Conditions

Keywords

regional anesthesiaPain ManagementSensory Mappingserratus intercostal plane blockexternal oblique plane blockeopbsipb

Outcome Measures

Primary Outcomes (1)

  • Cutaneous Sensory Block Area of EOPB and SIPB

    The primary outcome is the dermatomal mapping of the cutaneous sensory block areas produced by the serratus intercostal plane block (SIPB) and external oblique plane block (EOPB), and the comparison of sensory block extent between the two techniques.

    30 minutes after block application

Secondary Outcomes (3)

  • Coverage of Surgical Port Entry Sites by the Sensory Block Area

    30 minutes after block application

  • Maximum and Minimum Spread of the Cutaneous Sensory Block Area

    30 minutes after block application

  • Block Application Duration

    From needle insertion to completion of local anesthetic injection

Study Arms (2)

EOPB Group

Patients undergoing laparoscopic cholecystectomy who receive an ultrasound-guided External Oblique Plane Block (EOPB) for postoperative analgesia. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points.

Procedure: External Oblique Plane Block (EOPB)

SIPB Group

Patients undergoing laparoscopic cholecystectomy who receive an ultrasound-guided Serratus Intercostal Plane Block (SIPB) for postoperative analgesia. Bilateral blocks will be performed using 0.25% bupivacaine (25 mL per side, total 50 mL). Sensory block areas will be evaluated using pinprick at predefined time points.

Procedure: Serratus Intercostal Plane Block (SIPB)

Interventions

Ultrasound-guided External Oblique Plane Block (EOPB) performed bilaterally using 0.25% bupivacaine (25 mL per side, total 50 mL) for postoperative analgesia in laparoscopic cholecystectomy.

EOPB Group

Ultrasound-guided Serratus Intercostal Plane Block (SIPB) performed bilaterally using 0.25% bupivacaine (25 mL per side, total 50 mL) for postoperative analgesia in laparoscopic cholecystectomy.

SIPB Group

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients who are scheduled to undergo elective laparoscopic cholecystectomy surgery under general anesthesia at the Department of Anesthesiology, Samsun University Training and Research Hospital. A total of 40 patients will be enrolled and divided into two groups: EOPB (n=20) and SIPB (n=20). Each participant will receive ultrasound-guided regional anesthesia according to their assigned group, and sensory mapping will be performed postoperatively.

You may qualify if:

  • Patients scheduled for elective laparoscopic cholecystectomy surgery and who have received a regional anesthesia technique for this purpose.
  • Aged between 18-75 years.
  • Belonging to ASA I-III group.
  • Having provided written informed consent.

You may not qualify if:

  • Patients who refuse to participate.
  • Patients who did not receive a block.
  • Patients classified as ASA IV.
  • History of previous abdominal surgery (affecting the laparoscopic approach).
  • Patients with cognitive dysfunction or inability to cooperate.
  • Patients diagnosed with psychiatric disorders (schizophrenia, mania, depression, etc.).
  • Patients who have been using antipsychotic medication for more than 4 weeks.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55200, Turkey (Türkiye)

RECRUITING

Related Publications (3)

  • Nielsen TD, Moriggl B, Barckman J, Kolsen-Petersen JA, Soballe K, Borglum J, Bendtsen TF. The Lateral Femoral Cutaneous Nerve: Description of the Sensory Territory and a Novel Ultrasound-Guided Nerve Block Technique. Reg Anesth Pain Med. 2018 May;43(4):357-366. doi: 10.1097/AAP.0000000000000737.

    PMID: 29381568BACKGROUND
  • Dost B, Turunc E, Kaya C, Sahin CA, Genc C, Yucel SM, Demirag MK, Karakaya D. Maximum extension and regression rate of cutaneous sensory block: superficial vs. deep parasternal intercostal plane blocks in patients undergoing open cardiac surgery. J Clin Anesth. 2025 Jul;105:111888. doi: 10.1016/j.jclinane.2025.111888. Epub 2025 May 30.

    PMID: 40449315BACKGROUND
  • Genc C, Tulgar S, Akgun C, Avci MA, Yesilyurt B, Yildiz B, DE Cassai A. Maximum extension and regression rate of cutaneous sensory block obtained with the external oblique intercostal block or the modified thoracoabdominal nerves block through perichondrial approach in patients undergoing laparoscopic cholecystectomy. Minerva Anestesiol. 2024 Nov;90(11):979-988. doi: 10.23736/S0375-9393.24.18213-2.

    PMID: 39545654BACKGROUND

MeSH Terms

Conditions

Agnosia

Condition Hierarchy (Ancestors)

Perceptual DisordersNeurobehavioral ManifestationsNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Hatice Selcuk Kusderci, M.D.

    Samsun University Training and Research Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hatice Selcuk Kusderci, M.D.

CONTACT

Mert Yılmaz, M.D.

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 21, 2025

First Posted

March 3, 2026

Study Start

November 15, 2025

Primary Completion (Estimated)

May 15, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

March 3, 2026

Record last verified: 2026-02

Locations