Laparoscopic CholecystectomyNCT07445854
Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain Management, run by Samsun University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Laparoscopic Cholecystectomy, Postoperative Pain Management, Regional Anesthesia
- What is being tested?
- External Oblique Plane Block (EOPB) and Serratus Intercostal Plane Block (SIPB)
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 2025to 1 Jun 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Samsun University, Samsun Training and Research Hospital
Samsun, Ilkadım, 55200
Hatice Selçuk Kuşderci, 905052159896
Mert Yilmaz, 905326699555
About this study
Official title: 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.
Read the 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.
- Being tested
- External Oblique Plane Block (EOPB), Serratus Intercostal Plane Block (SIPB)
- Keywords
- regional anesthesia, Pain Management, Sensory Mapping, serratus intercostal plane block, external oblique plane block, eopb, sipb
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Plane Block (EOPB)Procedure or surgery
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 or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Procedure: Serratus Intercostal Plane Block (SIPB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 30 minutes after block application
Secondary outcomes (3)
Coverage of Surgical Port Entry Sites by the Sensory Block Area
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.
Measured: 30 minutes after block application
Maximum and Minimum Spread of the Cutaneous Sensory Block Area
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.
Measured: 30 minutes after block application
Block Application Duration
During regional anesthesia administration, the duration of block application will be measured in minutes for each technique and compared between the two groups.
Measured: From needle insertion to completion of local anesthetic injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2026
- Study start15 Nov 2025
- Primary completion15 May 2026 (estimated)
- Study completion1 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Laparoscopic CholecystectomyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hatice Selcuk Kusderci, M.D., Principal investigator, Samsun University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07445854
- Sponsor's protocol ID
- GOKAEK 2025/20/13
- Status last verified
- Feb 2026
- First submitted
- 21 Nov 2025
- Last updated
- 3 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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.
PubMed 29381568Dost 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.
PubMed 40449315Genc 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.
PubMed 39545654
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sensory Analysis and Cutaneous Mapping of Different Regional Anesthesia Techniques in Laparoscopic Cholecystectomy Surgery: A Prospective Observational Study
- ClinicalTrials.gov ID
- NCT07445854
- Acronym / sponsor ID
- GOKAEK 2025/20/13
- Keywords
- regional anesthesia, Pain Management, Sensory Mapping, serratus intercostal plane block, external oblique plane block, eopb, sipb
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 15 May 2026 (estimated)
- Study completion
- 1 Jun 2026 (estimated)
- First posted
- 3 Mar 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| EOPB Group | – | Procedure: External Oblique Plane Block (EOPB)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. |
| SIPB Group | – | Procedure: Serratus Intercostal Plane Block (SIPB)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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| External Oblique Plane Block (EOPB)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. | Procedure or surgery | EOPB Group |
| Serratus Intercostal Plane Block (SIPB)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. | Procedure or surgery | SIPB Group |
Primary outcome
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.
3 secondary outcomes
Coverage of Surgical Port Entry Sites by the Sensory Block Area
Time frame: 30 minutes after block application
Maximum and Minimum Spread of the Cutaneous Sensory Block Area
Time frame: 30 minutes after block application
Block Application Duration
Time frame: From needle insertion to completion of local anesthetic injection
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2026.
- Background: PubMed 29381568Nielsen 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.
- Background: PubMed 40449315Dost 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.
- Background: PubMed 39545654Genc 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hatice Selcuk Kusderci, M.D. principal investigator
Samsun University Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Laparoscopic Cholecystectomy and Postoperative Pain Management, run by Samsun University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 3 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hatice Selcuk Kusderci, M.D. (+905052159896, drkusderci@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cutaneous Sensory Block Area of EOPB and SIPB (time frame: 30 minutes after block application). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07445854, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Mar 2026; AzTrials last refreshed its copy on 6 Nov 2026.