Postoperative PainNCT07777172
Recto-Intercostal Fascial Plane and External Oblique Intercostal Blocks for Pain in Laparoscopic Cholecystectomyin Laparoscopic Cholecystectomy
A study testing Group EOIPB (External Oblique Intercostal Plane Block) and Group EOIPB + RIFPB (Combined Blocks) in people with Postoperative Pain and Cholecystectomy, Laparoscopic, run by Ankara Etlik City Hospital at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain, Cholecystectomy, Laparoscopic
- What is being tested?
- Group EOIPB (External Oblique Intercostal Plane Block) and Group EOIPB + RIFPB (Combined Blocks)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 14 Sep 2026to 15 Mar 2027
- Phase
- Interventional
- 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
Who may be able to join
- Aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients scheduled for elective laparoscopic cholecystectomy
Who cannot join
- Known allergy to local anesthetics
- Infection at the procedure/injection site
- Severe coagulopathy or use of anticoagulants
- Chronic opioid consumption or history of neuropathic pain
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
Ankara Etlik City Hospital
Ankara, Yenimahalle\Ankara, 06170
İbrahim MD Topcu, 05437860316, ibrahimtpc78@gmail.com
Musa Assoc.Prof Zengin, 00905307716235, musazengin@gmail.com
About this study
Official title: Does the Addition of Recto-Intercostal Fascial Plane Block to External Oblique Intercostal Plane Block Improve the Quality of Postoperative Analgesia in Laparoscopic Cholecystectomy? A Randomized Controlled Trial
Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort.
This randomized controlled trial aims to evaluate the efficacy of adding a recto-intercostal fascial plane block (RIFPB) to an external oblique intercostal plane block (EOIPB). Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to receive either an EOIPB alone or a combination of EOIPB and RIFPB. The primary objective is to determine if the combined block approach provides superior postoperative analgesia, evaluated by compared to the EOIPB alone.
- Conditions
- Postoperative Pain, Cholecystectomy, Laparoscopic
- Being tested
- Group EOIPB (External Oblique Intercostal Plane Block), Group EOIPB + RIFPB (Combined Blocks)
- Keywords
- External Oblique Intercostal Plane Block, Recto-Intercostal Fascial Plane Block, Fascial Plane Block, Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group EOIPB (External Oblique Intercostal Plane Block)Procedure or surgery
Patients will undergo bilateral EOIPB procedure using 20 ml of 0.20% bupivacaine on each side under ultrasound guidance.
Group EOIPB + RIFPB (Combined Blocks)Procedure or surgery
Patients will undergo bilateral EOIPB and RIFPB procedures under ultrasound guidance using 20 ml of 0.20% bupivacaine for the EOIPB block and 15 ml of 0.20% bupivacaine for the RIFPB on each side.
| Study group | Role | What they receive |
|---|---|---|
| Group EOIPB (External Oblique Intercostal Plane Block) | Active comparator | Patients in this group will undergo ultrasound-guided external oblique intercostal plane block (EOIPB) after general anesthesia and before surgical incision. The block will be performed bilaterally using 20 mL of % 0.20 bupivacaine on each side. Receives: Procedure: Group EOIPB (External Oblique Intercostal Plane Block) |
| Group EOIPB + RIFPB (Combined Blocks) | Active comparator | Patients in this group will receive both an ultrasound-guided external oblique intercostal plane block (EOIPB) and a recto-intercostal fascial plane block(RIFPB) after the induction of general anesthesia and prior to surgical incision. The procedures will be performed bilaterally. The EOIPB block will be administered using 20 mL of % 0.20 bupivacaine, and the RIFPB will be administered using 15 mL of % 0.20 bupivacaine on each side. Receives: Procedure: Group EOIPB + RIFPB (Combined Blocks) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain Intensity
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery.
Measured: 4 hours after surgery
Secondary outcomes (4)
Postoperative Pain Intensity
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 1, 8, 12, and 24 hours after surgery.
Measured: Up to 24 hours
Postoperative Pain Intensity
ain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) while coughing. Pain assessment will be made at 1, 4, 8, 12, and 24 hours after surgery.
Measured: Up to 24 hours
Total Postoperative Opioid Consumption
The total amount of opioid consumed by the patient will be recorded.
Measured: Up to 24 hours
Severity of Postoperative Nausea and Vomiting (PONV)
The severity of postoperative nausea will be assessed using an 11-point numerical rating scale (NRS), ranging from 0 to 10, where 0 indicates no nausea and 10 indicates the worst possible nausea. Vomiting will be recorded as the number of vomiting episodes. Nausea severity will be assessed at 1, 4, 8, 12, and 24 hours after surgery. Higher NRS scores indicate greater nausea severity.
Measured: Up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Aug 2026
- Study start14 Sep 2026
- Primary completion1 Mar 2027 (estimated)
- Study completion15 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Ankara Etlik City HospitalThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ankara Etlik City Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, İbrahim Topcu, Ankara Etlik City Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07777172
- Sponsor's protocol ID
- AEŞH-EK-2026-170
- Status last verified
- Oct 2026
- First submitted
- 17 Aug 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does the Addition of Recto-Intercostal Fascial Plane Block to External Oblique Intercostal Plane Block Improve the Quality of Postoperative Analgesia in Laparoscopic Cholecystectomy? A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07777172
- Acronym / sponsor ID
- AEŞH-EK-2026-170
- Conditions
- Postoperative Pain, Cholecystectomy, Laparoscopic
- Keywords
- External Oblique Intercostal Plane Block, Recto-Intercostal Fascial Plane Block, Fascial Plane Block, Regional Anesthesia, Postoperative Analgesia, Multimodal Analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Ankara Etlik City HospitalOther government
- Study start
- 14 Sep 2026 (actual)
- Primary completion
- 1 Mar 2027 (estimated)
- Study completion
- 15 Mar 2027 (estimated)
- First posted
- 20 Aug 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.
Laparoscopic cholecystectomy is a common surgical procedure that can cause significant postoperative pain, particularly originating from trocar insertion sites. Regional anesthesia techniques are frequently used as part of multimodal analgesia to improve patient comfort.
This randomized controlled trial aims to evaluate the efficacy of adding a recto-intercostal fascial plane block (RIFPB) to an external oblique intercostal plane block (EOIPB). Patients scheduled for elective laparoscopic cholecystectomy will be randomly assigned to receive either an EOIPB alone or a combination of EOIPB and RIFPB. The primary objective is to determine if the combined block approach provides superior postoperative analgesia, evaluated by compared to the EOIPB alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group EOIPB (External Oblique Intercostal Plane Block) | Active comparator | Procedure: Group EOIPB (External Oblique Intercostal Plane Block)Patients in this group will undergo ultrasound-guided external oblique intercostal plane block (EOIPB) after general anesthesia and before surgical incision. The block will be performed bilaterally using 20 mL of % 0.20 bupivacaine on each side. |
| Group EOIPB + RIFPB (Combined Blocks) | Active comparator | Procedure: Group EOIPB + RIFPB (Combined Blocks)Patients in this group will receive both an ultrasound-guided external oblique intercostal plane block (EOIPB) and a recto-intercostal fascial plane block(RIFPB) after the induction of general anesthesia and prior to surgical incision. The procedures will be performed bilaterally. The EOIPB block will be administered using 20 mL of % 0.20 bupivacaine, and the RIFPB will be administered using 15 mL of % 0.20 bupivacaine on each side. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Aged between 18 and 75 years
- American Society of Anesthesiologists (ASA) physical status I, II, or III
- Patients scheduled for elective laparoscopic cholecystectomy
Key exclusion criteria (4 listed)
- Known allergy to local anesthetics
- Infection at the procedure/injection site
- Severe coagulopathy or use of anticoagulants
- Chronic opioid consumption or history of neuropathic pain
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 EOIPB (External Oblique Intercostal Plane Block)Patients will undergo bilateral EOIPB procedure using 20 ml of 0.20% bupivacaine on each side under ultrasound guidance. | Procedure or surgery | Group EOIPB (External Oblique Intercostal Plane Block) |
| Group EOIPB + RIFPB (Combined Blocks)Patients will undergo bilateral EOIPB and RIFPB procedures under ultrasound guidance using 20 ml of 0.20% bupivacaine for the EOIPB block and 15 ml of 0.20% bupivacaine for the RIFPB on each side. | Procedure or surgery | Group EOIPB + RIFPB (Combined Blocks) |
Primary outcome
Postoperative Pain Intensity
Time frame: 4 hours after surgery
Pain will be assessed using a visual analog scale from 0 mm (no pain) to 100 mm (worst pain) at rest. Pain assessment at rest will be made at 4 hours after surgery.
4 secondary outcomes
Postoperative Pain Intensity
Time frame: Up to 24 hours
Postoperative Pain Intensity
Time frame: Up to 24 hours
Total Postoperative Opioid Consumption
Time frame: Up to 24 hours
Severity of Postoperative Nausea and Vomiting (PONV)
Time frame: Up to 24 hours
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 16 Oct 2026.
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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.
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 EOIPB (External Oblique Intercostal Plane Block) and Group EOIPB + RIFPB (Combined Blocks) in people with Postoperative Pain and Cholecystectomy, Laparoscopic, run by Ankara Etlik City 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 3 inclusion and 4 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 16 Oct 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 İbrahim MD Topcu (05437860316, ibrahimtpc78@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Pain Intensity (time frame: 4 hours after 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 16 Oct 2026.