Laparoscopic CholecystectomyNCT06712498
INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS OF EXTERNAL OBLIQUE INTERCOSTAL PLAN BLOCK IN PATIENTS UNDERGOING LAPARASCOPIC CHOLESYSTECTOMY OPERATION
An observational study of Laparoscopic Cholecystectomy, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Laparoscopic Cholecystectomy
- What is being tested?
- External Oblique Intercostal Plane Block
- Type of treatment
- Surgery or procedure
- How many people
- 64 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 26 Nov 2024to 30 Dec 2024
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- None posted in the registry
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: operating
Who may be able to join
- Patients aged between 18-65
- and with ASA1-2 were included.
- Exclusion Criteria:• Patients younger than 18 years of age and older than 65 years of age
- Patients allergic to local anesthetics
- Patients with opioid and alcohol addiction
- Patients with perioperative signs of acute cholecystitis
- Patients with contraindications for laparoscopic surgery
- Cases with ASA III-IV were not included in the study.
Who cannot join
None listed.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Health Sciences University Gazi Yaşargil Training and Research Hospital
Diyarbakır, Kayapınar, 21070
About this study
Official title: INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS
Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.
- Conditions
- Laparoscopic Cholecystectomy
- Being tested
- External Oblique Intercostal Plane Block, control group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
External Oblique Intercostal Plane BlockProcedure or surgery
After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally).
control groupDrug
No intervention
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal plan block group | After endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). Receives: Procedure: External Oblique Intercostal Plane Block | |
| control group | No Intervention Receives: Drug: control group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Numeric Rating Scale
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome
Measured: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Visual Analogue Scale
The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing 'no pain' and 'worst pain imaginable'. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.
Measured: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Secondary outcomes (6)
Riker Sedation Agitation Scale
7 Dangerous Agitation ... If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome.
Measured: Immediately after extubation
Patient satisfaction score
Patients' satisfaction with the quality of pain management will be evaluated on the second postoperative day using the following scale: 1 = very unsatisfied; 2 = highly dissatisfied; 3 = medium; 4 = very satisfactory; 5 = very satisfactory
Measured: at the 24th postoperative hour
Postoperative vomiting and nausea
Postoperative vomiting and nausea: yes or no
Measured: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Opioid use
Tramadol use
Measured: Postoperative 24 hours
Mean Arter Pressure
mm/hg
Measured: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Heart Rate
beats/minute
Measured: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2024
- Study start26 Nov 2024
- Primary completion26 Dec 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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
- 64 participants (actual)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mazlum Dursun, Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06712498
- Sponsor's protocol ID
- mazlum
- Status last verified
- Nov 2024
- First submitted
- 26 Nov 2024
- Last updated
- 24 Nov 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dursun M, Soner HT, Topalel S, Erbatur ME, Uzundere O, Kaya S, Gokcek E. Effects of external oblique intercostal plane block on postoperative pain and analgesic requirement in laparoscopic cholecystectomy: a prospective randomized controlled trial. BMC Anesthesiol. 2026 Jun 17. doi: 10.1186/s12871-026-04029-x. Online ahead of print.
PubMed 42310559
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- INVESTIGATION OF THE INTRAOPERATIVE AND POSTOPERATIVE EFFECTS
- ClinicalTrials.gov ID
- NCT06712498
- Acronym / sponsor ID
- mazlum
- Conditions
- Laparoscopic Cholecystectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 64 participants (actual)
- Lead sponsor
- Saglik Bilimleri Universitesi Gazi Yasargil Training and Research HospitalUniversity, hospital or other
- Study start
- 26 Nov 2024 (actual)
- Primary completion
- 26 Dec 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 2 Dec 2024 (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.
Objective: Regional anesthesia techniques, such as peripheral nerve blocks, have a lower side effect profile and higher patient satisfaction compared to central blocks. With the introduction of Ultrasonography (USG), these techniques have become more commonly and reliably performed. The purpose of our study is to compare parameters such as intraoperative hemodynamics, postoperative analgesic requirement, and patient satisfaction between patients undergoing External Oblique Intercostal Plane Block (EOIB) with those who did not receive EOIB, which has few studies conducted on it.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal plan block group | – | Procedure: External Oblique Intercostal Plane BlockAfter endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). |
| control group | – | Drug: control groupNo Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- operating
Key inclusion criteria (8 listed)
- Patients aged between 18-65
- and with ASA1-2 were included.
- Exclusion Criteria:• Patients younger than 18 years of age and older than 65 years of age
- Patients allergic to local anesthetics
- Patients with opioid and alcohol addiction
Key exclusion criteria (0 listed)
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 Intercostal Plane BlockAfter endotracheal intubation, a 22-gauge 100 mm long block needle will be inserted at the T6-T7 level under USG guidance and bilateral EOIB will be applied with 20 cc of 0.25% Bupivacaine on each side under the external oblique intercostal muscle (total 40ml bilaterally). | Procedure or surgery | External oblique intercostal plan block group |
| control groupNo intervention | Drug | control group |
Primary outcome
Numeric Rating Scale
Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
They will be numbered from 1 to 10. If reporting a score on a scale, please include the unabbreviated scale title, the minimum and maximum values, and whether higher scores mean a better or worse outcome
Visual Analogue Scale
Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
The Visual Analogue Scale (VAS) is a subjective measure of pain. It consists of a 10cm line with two endpoints representing 'no pain' and 'worst pain imaginable'. Patients are asked to rate their pain by placing a mark on the line corresponding to their current level of pain. The distance along the line from the 'no pain' marker is then measured with a ruler giving a pain score out of 10.
6 secondary outcomes
Riker Sedation Agitation Scale
Time frame: Immediately after extubation
Patient satisfaction score
Time frame: at the 24th postoperative hour
Postoperative vomiting and nausea
Time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours
Opioid use
Time frame: Postoperative 24 hours
Mean Arter Pressure
Time frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Heart Rate
Time frame: when you come to the operating room table, after block Intraoperative 10 minutes,30 minutes postoperative 2,6,12 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2025.
- Derived from this study: PubMed 42310559Dursun M, Soner HT, Topalel S, Erbatur ME, Uzundere O, Kaya S, Gokcek E. Effects of external oblique intercostal plane block on postoperative pain and analgesic requirement in laparoscopic cholecystectomy: a prospective randomized controlled trial. BMC Anesthesiol. 2026 Jun 17. doi: 10.1186/s12871-026-04029-x. Online ahead of print.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
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, run by Saglik Bilimleri Universitesi Gazi Yasargil Training and Research Hospital 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 8 inclusion and 0 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: finished, as of the sponsor's last update on 24 Nov 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Numeric Rating Scale (time frame: Postoperative 30.second,2 hours, 6 hours,12 hours,24 hours). The study lists 2 primary outcomes in all. 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 NCT06712498, which also lists 1 linked publication.
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 24 Nov 2025.