- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07445854
Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques
Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques in Laparoscopic Cholecystectomy Surgery: A Prospective Observational Study
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.
Study Overview
Status
Intervention / Treatment
Detailed Description
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.
Study Type
Enrollment (Estimated)
Contacts and Locations
Study Contact
- Name: Hatice Selcuk Kusderci, M.D.
- Phone Number: +905052159896
- Email: drkusderci@hotmail.com
Study Contact Backup
- Name: Mert Yılmaz, M.D.
- Phone Number: +905326699555
- Email: dryilmazmert@gmail.com
Study Locations
-
-
Ilkadım
-
Samsun, Ilkadım, Turkey (Türkiye), 55200
- Recruiting
- Samsun University, Samsun Training and Research Hospital
-
Contact:
- Hatice Selçuk Kuşderci
- Phone Number: 905052159896
-
Contact:
- Mert Yilmaz
- Phone Number: 905326699555
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
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.
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
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. |
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.
|
|
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. |
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes after block application
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
|
30 minutes after block application
|
|
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.
|
30 minutes after block application
|
|
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.
|
From needle insertion to completion of local anesthetic injection
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Hatice Selcuk Kusderci, M.D., Samsun University Training and Research Hospital
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- GOKAEK 2025/20/13
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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