AnalgesiaNCT05444985
Postoperative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgery
A study testing Pain Management in people with Analgesia and Pain, Postoperative, run by Samsun University at 1 site in Turkey (Türkiye).
Trial summary
The aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Analgesia, Pain, Postoperative
- What is being tested?
- Pain Management
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Jul 2022to 9 May 2023
- 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
- No healthy volunteers
- 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: Post-operative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgeries.
The aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.
Read the detailed description
The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, external oblique intercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (external oblique intercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.
For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed at least 20 previous successful and uncomplicated procedures.
- Conditions
- Analgesia, Pain, Postoperative
- Being tested
- Pain Management
- Keywords
- External oblique intercostal block, Pain management
- 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.
Pain ManagementOther
Regional anesthetic techniques for peri-operative pain management after surgery.
| Study group | Role | What they receive |
|---|---|---|
| External Oblique Intercostal Block Group | Experimental | While patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening. Receives: Other: Pain Management |
| Control | Active comparator | Patients in the control group will not have any intervention concerning regional anesthesia. Receives: Other: Pain Management |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative opioid consumption
Contramal consumption in the first 24 hours after surgery
Measured: 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 posted6 Jul 2022
- Study start17 Jul 2022
- Primary completion9 May 2023
- Study completion9 May 2023
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
- One interventional group and one control 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
- Hatice Kusderci, M.D., Principal investigator, Samsun University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05444985
- Sponsor's protocol ID
- HATICE55
- Status last verified
- Jul 2023
- First submitted
- 28 Jun 2022
- Last updated
- 21 Jul 2023
- 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 21 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-operative Analgesic Effects of Bilateral External Oblique Intercostal Block in Laparoscopic Cholecystectomy Surgeries.
- ClinicalTrials.gov ID
- NCT05444985
- Acronym / sponsor ID
- HATICE55
- Conditions
- Analgesia, Pain, Postoperative
- Keywords
- External oblique intercostal block, Pain management
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Samsun UniversityUniversity, hospital or other
- Study start
- 17 Jul 2022 (actual)
- Primary completion
- 9 May 2023 (actual)
- Study completion
- 9 May 2023 (actual)
- First posted
- 6 Jul 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 aim of our study is to reduce postoperative pain by performing external oblique intercostal block in L/S cholecystectomy surgeries. Our main goal is to provide well managed post-operative analgesia.
Detailed description
The patients will be divided into two groups and general anesthesia will be applied to all of them. There will be no regional anesthetic technique to be performed, on the other hand, external oblique intercostal nerve block will be applied to patients in the other group before the patients are extubated. Study randomization is done with computer-generated randomization codes (computer-generated) by a physician who will not participate in patient follow-up. Interfascial plane block (external oblique intercostal block) will be given to the anesthesiologist in a sealed envelope by an independent assistant staff outside the study, the patient will not know which block is applied. The anesthetist who made the block will not participate in the pain follow-up of the patients. Postoperative pain assessment and data collection will be performed by another anesthetist blinded to the study.
For the standardization, the block procedure will be performed by an experienced anesthesiologist who has performed 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
- One interventional group and one control group.
| Arm | Type | Receives |
|---|---|---|
| External Oblique Intercostal Block Group | Experimental | Other: Pain ManagementWhile patients are still under general anesthesia, external oblique intercostal block (EOIB) will be performed bilaterally according to appropriate asepsis/antisepsis rules before awakening. |
| Control | Active comparator | Other: Pain ManagementPatients in the control group will not have any intervention concerning regional anesthesia. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- BMI < 35 kg/m²
- Patients with ASA scores I and II
Key exclusion criteria (7 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
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 |
|---|---|---|
| Pain ManagementRegional anesthetic techniques for peri-operative pain management after surgery. | Other | Control, External Oblique Intercostal Block Group |
Primary outcome
Postoperative opioid consumption
Time frame: 24 hours
Contramal 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 21 Jul 2023.
- 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.
Hatice Kusderci, M.D. 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 Pain Management in people with Analgesia and Pain, Postoperative, 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 2 inclusion and 7 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 21 Jul 2023. 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: 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 21 Jul 2023.