Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadım, 55200, Turkey (Türkiye)
Location status: Recruiting
NCT Number: NCT07445854
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.
Interested in participating?
Request Info18 year–75 year
All sexes
Observational
Samsun, Ilkadım, 55200, Turkey (Türkiye)
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
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.
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.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Hatice Selcuk Kusderci, M.D.
CONTACT
Mert Yılmaz, M.D.
CONTACT
Samsun University
Other
Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques in Laparoscopic Cholecystectomy Surgery: A Prospective Observational Study
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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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