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NCT Number: NCT07445854

Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques

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.

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Key information

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Samsun University, Samsun Training and Research Hospital

Samsun, Ilkadım, 55200, Turkey (Türkiye)

Location status: Recruiting

Location contact

Hatice Selçuk Kuşderci

CONTACT

905052159896

Mert Yilmaz

CONTACT

905326699555

About this study

This single-center, prospective observational study will be conducted at Samsun University Training and Research Hospital operating rooms between November 2025 and June 2026.

The study will include patients aged 18-75 years, classified as ASA I-III, who are scheduled for elective laparoscopic cholecystectomy and have provided written informed consent. For pain management, these patients will undergo either serratus intercostal plane block (SIPB) or external oblique plane block (EOPB) under ultrasound guidance. Patients receiving one of these two block techniques will be observed, and the sensory block areas created will be evaluated.

Both blocks will be performed bilaterally and under ultrasound guidance immediately before surgery. 0.25% bupivacaine will be used for the block applications, and 25 mL of local anesthetic will be injected into each side (a total of 50 mL). Thirty minutes after the block, patients will be evaluated for cutaneous sensory block using the "pinprick test." This evaluation will be standardized according to specific dermatome levels, covering the midline and both abdominal quadrants, in order to describe sensory loss on the skin.

The data obtained will be analyzed to determine the dermatomal spread and the minimum and maximum areas of effect of the blocks. Additionally, findings related to block application time will be recorded observationally. A comparison between the groups will be made, and the degree of overlap between the sensory block areas and the surgical incision site will be evaluated.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

External Oblique Plane Block (EOPB)

Procedure

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.

Serratus Intercostal Plane Block (SIPB)

Procedure

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.

Primary outcomes

  1. Cutaneous Sensory Block Area of EOPB and SIPB

    Time frame: 30 minutes after block application

    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.

Secondary outcomes

  1. Coverage of Surgical Port Entry Sites by the Sensory Block Area

    Time frame: 30 minutes after block application

    After examination and mapping of the cutaneous sensory area, surgical port entry sites will be marked on the patient by the surgeon. Port entry sites covered and not covered by the sensory block area will be assessed and compared between the two groups on a percentage basis.

  2. Maximum and Minimum Spread of the Cutaneous Sensory Block Area

    Time frame: 30 minutes after block application

    The minimum and maximum dermatomal boundaries of the cutaneous sensory block area produced by each regional anesthesia technique will be assessed using sensory mapping and compared between the two groups.

  3. Block Application Duration

    Time frame: From needle insertion to completion of local anesthetic injection

    During regional anesthesia administration, the duration of block application will be measured in minutes for each technique and compared between the two groups.

Study contacts

Contact information is provided by the study sponsor or research team.

Hatice Selcuk Kusderci, M.D.

CONTACT

[email protected]

+905052159896

Mert Yılmaz, M.D.

CONTACT

[email protected]

+905326699555

Sponsors and collaborators

Lead sponsor

Samsun University

Other

Registry information

Official study title

Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques in Laparoscopic Cholecystectomy Surgery: A Prospective Observational Study

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 3, 2026
Registry last updated
Mar 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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