AnalgesiaNCT06172465
Comparison of OSTAP and EOIP Blocks in Laparoscopic Cholecystectomies
A study testing EOIP and OSTAP in people with Analgesia and Pain, Post Operative, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Analgesia, Pain, Post Operative
- What is being tested?
- EOIP and OSTAP
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Jan 2024to 25 Nov 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- BMI < 35 kg/m² Patients with ASA scores I and II
Who cannot join
- Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies
Laparoscopic cholecystectomy (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.
Read the detailed description
Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.
For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.
- Conditions
- Analgesia, Pain, Post Operative
- Being tested
- EOIP, OSTAP
- Keywords
- laparoscopic cholecystectomy, oblique subcostal transversus abdominis plane block, external oblique interfascial plane block
- Medical subject headings
- Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EOIPOther
Ultrasound guided External oblique intercostal block will be performed bilaterally.
OSTAPOther
Ultrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally.
| Study group | Role | What they receive |
|---|---|---|
| group external oblique intercostal plane block | Active comparator | While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules at end of the surgery. Receives: Other: EOIP |
| group oblique subcostal transversus abdominis plane block | Active comparator | Ultrasound-guided bilateral OSTAP block performed at end of the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed Receives: Other: OSTAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
tramadol consumption in the first 24 hours after surgery
Measured: up to 24 hours
Secondary outcomes (3)
NRS scores
NRS scores in the first 24 hours after surgery
Measured: At 1,3, 6, 12, 18, 24 hours
Quality of recovery
QR15 scores
Measured: 24 hours
Nausea and vomiting
Nausea and vomiting scores in the first 24 hours
Measured: At 1,3, 6, 12, 18, 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2023
- Study start5 Jan 2024
- Primary completion24 Nov 2024
- Study completion25 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AnalgesiaStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- two interventional group
- Masking
- Triple blind
- Who is masked
- Participant, 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
- gamze MD ertaş, specialist, Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06172465
- Sponsor's protocol ID
- trunk block
- Status last verified
- Nov 2024
- First submitted
- 7 Dec 2023
- Last updated
- 27 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Bilateral Oblique Transversus Abdominis Plane Block (OSTAPB) and Bilateral External Oblique Intercostal Plane Block (EOIPB) in Laparoscopic Cholecystectomies
- ClinicalTrials.gov ID
- NCT06172465
- Acronym / sponsor ID
- trunk block
- Conditions
- Analgesia, Pain, Post Operative
- Keywords
- laparoscopic cholecystectomy, oblique subcostal transversus abdominis plane block, external oblique interfascial plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 5 Jan 2024 (actual)
- Primary completion
- 24 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 15 Dec 2023 (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 (LC) surgery causes postoperative severe pain. As part of multimodal analgesia aimed at reducing postoperative opioid consumption and providing effective analgesia, ultrasound (US)-guided transversus abdominis plane block (TAP) and external oblique intercostal plane block (EOIPB) will be applied as regional anesthesia methods. There is no study in the literature comparing OSTAP and EOIP blocks, and our goal is to evaluate the analgesic effectiveness between OSTAP and EOIP blocks in LC surgeries.
Detailed description
Patients will be divided into two groups, and general anesthesia will be administered to all. Before extubation, one group will receive an external oblique intercostal nerve block, while the other group will receive an oblique subcostal transversus abdominis plane block. The randomization of the study will be carried out by a computer-generated randomization code (computer-generated) by a physician who will not be involved in patient follow-up. The interfascial plane block (either external oblique intercostal block or oblique subcostal block) will be provided to an anesthesiologist in a sealed envelope by an independent assistant staff member outside the study. The patient will not be aware of which block is applied. The anesthesiologist performing the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be conducted by another anesthesiologist unaware of the study.
For standardization, the block procedure will be performed by an experienced anesthesiologist who has completed at least 20 previous successful and uncomplicated procedures.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
- Model description
- two interventional group
| Arm | Type | Receives |
|---|---|---|
| group external oblique intercostal plane block | Active comparator | Other: EOIPWhile patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules at end of the surgery. |
| group oblique subcostal transversus abdominis plane block | Active comparator | Other: OSTAPUltrasound-guided bilateral OSTAP block performed at end of the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- BMI < 35 kg/m² Patients with ASA scores I and II
Key exclusion criteria (1 listed)
- Patients who do not want to be included in the study Psychiatric and neurological disease with blurred consciousness Patients with ASA > 3 BMI > 35 kg/m² Abnormality in coagulation parameters History of allergy to local anesthetic drugs Infection at the injection site
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 |
|---|---|---|
| EOIPUltrasound guided External oblique intercostal block will be performed bilaterally. | Other | group external oblique intercostal plane block |
| OSTAPUltrasound guided oblique subcostal transversus abdominis plane block will be performed bilaterally. | Other | group oblique subcostal transversus abdominis plane block |
Primary outcome
Postoperative opioid consumption
Time frame: up to 24 hours
tramadol consumption in the first 24 hours after surgery
3 secondary outcomes
NRS scores
Time frame: At 1,3, 6, 12, 18, 24 hours
Quality of recovery
Time frame: 24 hours
Nausea and vomiting
Time frame: At 1,3, 6, 12, 18, 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 27 Nov 2024.
- 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.
gamze MD ertaş, specialist principal investigator
Samsun University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing EOIP and OSTAP in people with Analgesia and Pain, Post Operative, 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 1 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 27 Nov 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: up to 24 hours). 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 27 Nov 2024.