Pain ManagementNCT06869837
EOIPB in Laparoscopic Cholecystectomy: Impact on Opioid Consumption Guided by ANI and Analgesia Quality
A study testing Group EOİPB in people with Pain Management and Laparoscopic Cholecystectomy Surgery, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain Management, Laparoscopic Cholecystectomy Surgery
- What is being tested?
- Group EOİPB
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 8 Apr 2025to 20 Dec 2025
- Phase
- Interventional
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Participants who will undergo elective laparoscopic cholecystectomy surgery,
- Age 18-70,
- ASA I-II physical status,
- Body mass index (BMI) < 35 kg/m²,
- Participants who have written consent to participate in the study
Who cannot join
- Participants with routine analgesic consumption,
- Those with coagulopathy,
- Those with a history of local anesthetic allergy,
- Those with cardiac arrhythmia and pacemaker,
- ASA III and above, Those with dementia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Samsun University, Samsun Training and Research Hospital
Samsun, İ̇lkadim
About this study
Official title: Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial
The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.
Read the detailed description
Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.
- Being tested
- Group EOİPB
- Keywords
- external oblique intercostal plane block
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group EOİPBOther
Bilateral external oblique intercostal plane block under USG guidance will be applied 45 minutes before cholecystectomy surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group EOİPB | Active comparator | Bilateral External oblique intercostal plane block will be applied 45 minutes before surgery. Receives: Other: Group EOİPB |
| Group Control | No intervention | No intervention will be made in this group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative opioid consumption
Total amount of remifentanil consumed during cholecystectomy surgery
Measured: During surgery
Secondary outcomes (3)
Numeric rating scale for postoperative pain intensity
Evaluated with a Numerical rating scale (NRS) from 0 to 10. (0=no pain; 10=worst imaginable pain)
Measured: up to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours)
Quality of Recovery - 15 score
The impact of surgical and anesthetic interventions on perioperative quality of life and ability to resume routine life activities will be assessed using the Quality of Recovery (QoR) tool. Each question is scored between 0 and 10. The survey result varies between 0-150 points based on the answers given by the patients. Higher scores indicate better recovery.
Measured: Postoperative 24th hour
Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)
Evaluated with a NRS from 0 to 10 and fentanyl will be administered when NRS is 4 and above. Fentanyl consumed will be recorded.
Measured: 30 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start8 Apr 2025
- Primary completion15 Dec 2025
- Study completion20 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Samsun University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- HALE K CELIK, Study director, SAMSUN UNİVERSITY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06869837
- Sponsor's protocol ID
- OMUKAEK 2024/269
- Status last verified
- Apr 2025
- First submitted
- 4 Mar 2025
- Last updated
- 6 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The datasets used and/ or analysed during the current study are available from the corresponding author on reasonable request.
Study at a glance
From the registry record, last updated by the sponsor on 6 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of External Oblique Intercostal Plane Block Applied in Laparoscopic Cholecystectomy Surgery on Intraoperative Opioid ConsumptionDetermined by ANI (Analgesia Nociceptive Index) and Postoperative Analgesia Quality Guide; A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06869837
- Acronym / sponsor ID
- OMUKAEK 2024/269
- Keywords
- external oblique intercostal plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 8 Apr 2025 (actual)
- Primary completion
- 15 Dec 2025 (actual)
- Study completion
- 20 Dec 2025 (actual)
- First posted
- 11 Mar 2025 (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.
The aim of the study was to evaluate the response of regional anesthesia to remifentanyl consumption in patients undergoing laparoscopic cholecystectomy surgery.
Detailed description
Routine anesthesia and analgesia protocol will be applied to all participants. The study aims to evaluate the remifentanyl consumption of the participants by dividing them into two groups as those with and without block and then performing their monitoring (pulse, mean arterial pressure with noninvasive measurement, oxygen saturation, Analgesia Nociception Index, Bispectral index). Remifentanil level will be adjusted according to the ANI value. The target is to keep the ANI between 50-70.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group EOİPB | Active comparator | Other: Group EOİPBBilateral External oblique intercostal plane block will be applied 45 minutes before surgery. |
| Group Control | No intervention | –No intervention will be made in this group. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Participants who will undergo elective laparoscopic cholecystectomy surgery,
- Age 18-70,
- ASA I-II physical status,
- Body mass index (BMI) < 35 kg/m²,
- Participants who have written consent to participate in the study
Key exclusion criteria (5 listed)
- Participants with routine analgesic consumption,
- Those with coagulopathy,
- Those with a history of local anesthetic allergy,
- Those with cardiac arrhythmia and pacemaker,
- ASA III and above, Those with dementia
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 |
|---|---|---|
| Group EOİPBBilateral external oblique intercostal plane block under USG guidance will be applied 45 minutes before cholecystectomy surgery. | Other | Group EOİPB |
Primary outcome
Intraoperative opioid consumption
Time frame: During surgery
Total amount of remifentanil consumed during cholecystectomy surgery
3 secondary outcomes
Numeric rating scale for postoperative pain intensity
Time frame: up to 24 hours (Will be evaluated at 1, 3, 6, 9, 12, 18, 24 hours)
Quality of Recovery - 15 score
Time frame: Postoperative 24th hour
Fentanyl consumption at 30 minutes after arrival in the PACU(post anesthesia care unit)
Time frame: 30 minutes
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 6 Jan 2026.
- Individual participant dataSharing planned: No. The datasets used and/ or analysed during the current study are available from the corresponding author on reasonable request.
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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.
HALE K CELIK study director
SAMSUN UNİVERSITY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group EOİPB in people with Pain Management and Laparoscopic Cholecystectomy Surgery, 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 5 inclusion and 5 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 6 Jan 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?
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?
Intraoperative opioid consumption (time frame: During surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 6 Jan 2026.