AnalgesiaNCT05632991
External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy
A study testing ultrasound guided external oblique intercostal plane block and Subcostal Transversus Abdominis Plan Block Group in people with Analgesia, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Analgesia
- What is being tested?
- ultrasound guided external oblique intercostal plane block and Subcostal Transversus Abdominis Plan Block Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Dec 2022to 1 Jan 2024
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- American Society of Anesthesiologist's physiologic state I-III patients
- Laparoscopic cholecystectomy
Who cannot join
- Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Ultrasound Guided External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Prospective Randomized Study
The laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time.
However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery.
The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.
- Conditions
- Analgesia
- Being tested
- ultrasound guided external oblique intercostal plane block, Subcostal Transversus Abdominis Plan Block Group
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound guided external oblique intercostal plane blockOther
ultrasound guided external oblique intercostal plane block 20 ml local anesthetic each side
Subcostal Transversus Abdominis Plan Block GroupOther
ultrasound guided Subcostal Transversus Abdominis Plan Block Group 20 ml local anesthetic each side
| Study group | Role | What they receive |
|---|---|---|
| External oblique intercostal plane block | Active comparator | Ultrasound-guided External oblique intercostal plane block before surgery Receives: Other: ultrasound guided external oblique intercostal plane block |
| Subcostal Transversus Abdominis Plan Block Group | Active comparator | Ultrasound-guided Subcostal Transversus Abdominis Plan Block Group Receives: Other: Subcostal Transversus Abdominis Plan Block Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
First 24 hours total fentanyl consumption with patient controlled analgesia
Measured: first 24 hours
Secondary outcomes (1)
Visual analog pain score
Post operative pain will be evaluated with a Visual Analogue Scale (VAS) score of 0-10 (0= no pain and 10= worst imaginable pain)
Measured: postextubation 0-24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2022
- Study start1 Dec 2022
- Primary completion1 Sep 2023
- Study completion1 Jan 2024
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 AnalgesiaStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe 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, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05632991
- Sponsor's protocol ID
- ataunilapcholecystectomy
- Status last verified
- Mar 2024
- First submitted
- 21 Nov 2022
- Last updated
- 1 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
PubMed 24400824Leitao MM Jr, Malhotra V, Briscoe G, Suidan R, Dholakiya P, Santos K, Jewell EL, Brown CL, Sonoda Y, Abu-Rustum NR, Barakat RR, Gardner GJ. Postoperative pain medication requirements in patients undergoing computer-assisted ("Robotic") and standard laparoscopic procedures for newly diagnosed endometrial cancer. Ann Surg Oncol. 2013 Oct;20(11):3561-7. doi: 10.1245/s10434-013-3064-9.
PubMed 23797751Al S, Ahiskalioglu A, Karapinar YE, Yayik AM, Aydin ME, Celik EC, Ahiskalioglu EO, Doymus O. External oblique intercostal plane block as an alternative to subcostal TAP block for laparoscopic cholecystectomy: a prospective randomized study. BMC Anesthesiol. 2025 Dec 5;26(1):26. doi: 10.1186/s12871-025-03548-3.
PubMed 41351140
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided External Oblique Intercostal Plane Block vs. Transversus Abdominis Plane Block for Laparoscopic Cholecystectomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05632991
- Acronym / sponsor ID
- ataunilapcholecystectomy
- Conditions
- Analgesia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (actual)
- Primary completion
- 1 Sep 2023 (actual)
- Study completion
- 1 Jan 2024 (actual)
- First posted
- 1 Dec 2022 (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 laparoscopic approach has become the gold standard for many abdominal surgical procedures, including cholecystectomy. Compared to laparotomy, laparoscopy allows smaller incisions, reduces perioperative stress response, reduces postoperative pain, and results in shorter recovery time.
However, anaesthesia concerns in patients undergoing laparoscopic surgery are different from patients undergoing open abdominal surgery.
The aim of this study is to investigate the effect of the external oblique intercostal block, which is a new block, on postoperative pain score and opioid consumption.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| External oblique intercostal plane block | Active comparator | Other: ultrasound guided external oblique intercostal plane blockUltrasound-guided External oblique intercostal plane block before surgery |
| Subcostal Transversus Abdominis Plan Block Group | Active comparator | Other: Subcostal Transversus Abdominis Plan Block GroupUltrasound-guided Subcostal Transversus Abdominis Plan Block Group |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- American Society of Anesthesiologist's physiologic state I-III patients
- Laparoscopic cholecystectomy
Key exclusion criteria (1 listed)
- Chronic pain bleeding disorders renal or hepatic insufficiency patients on chronic non-steroidal anti-inflammatory medications emergency cases
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 |
|---|---|---|
| ultrasound guided external oblique intercostal plane blockultrasound guided external oblique intercostal plane block 20 ml local anesthetic each side | Other | External oblique intercostal plane block |
| Subcostal Transversus Abdominis Plan Block Groupultrasound guided Subcostal Transversus Abdominis Plan Block Group 20 ml local anesthetic each side | Other | Subcostal Transversus Abdominis Plan Block Group |
Primary outcome
Postoperative opioid consumption
Time frame: first 24 hours
First 24 hours total fentanyl consumption with patient controlled analgesia
1 secondary outcome
Visual analog pain score
Time frame: postextubation 0-24 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 1 Apr 2024.
- Background: PubMed 24400824Woldu SL, Weinberg AC, Bergman A, Shapiro EY, Korets R, Motamedinia P, Badani KK. Pain and analgesic use after robot-assisted radical prostatectomy. J Endourol. 2014 May;28(5):544-8. doi: 10.1089/end.2013.0783. Epub 2014 Jan 30.
- Background: PubMed 23797751Leitao MM Jr, Malhotra V, Briscoe G, Suidan R, Dholakiya P, Santos K, Jewell EL, Brown CL, Sonoda Y, Abu-Rustum NR, Barakat RR, Gardner GJ. Postoperative pain medication requirements in patients undergoing computer-assisted ("Robotic") and standard laparoscopic procedures for newly diagnosed endometrial cancer. Ann Surg Oncol. 2013 Oct;20(11):3561-7. doi: 10.1245/s10434-013-3064-9.
- Derived from this study: PubMed 41351140Al S, Ahiskalioglu A, Karapinar YE, Yayik AM, Aydin ME, Celik EC, Ahiskalioglu EO, Doymus O. External oblique intercostal plane block as an alternative to subcostal TAP block for laparoscopic cholecystectomy: a prospective randomized study. BMC Anesthesiol. 2025 Dec 5;26(1):26. doi: 10.1186/s12871-025-03548-3.
- Individual participant dataSharing planned: Undecided
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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?
A study testing ultrasound guided external oblique intercostal plane block and Subcostal Transversus Abdominis Plan Block Group in people with Analgesia, run by Ataturk 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 2 inclusion and 1 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 1 Apr 2024. 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?
Postoperative opioid consumption (time frame: first 24 hours). 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 NCT05632991, 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 1 Apr 2024.