ObesityNCT05663658
External Oblique Intercostal Plane Block for Laparoscopic Sleeve Gastrectomy
A study testing External oblique intercostal plane block in people with Obesity and Analgesia, run by Istinye University at 1 site in Turkey (Türkiye).
Trial summary
The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Obesity, Analgesia, Postoperative Pain
- What is being tested?
- External oblique intercostal plane block
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 23 Dec 2022to 15 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
- Age between 18 and 80 years
- Patients with American Society of Anesthesiology (ASA) physical status II-III
- Patients scheduled for a laparoscopic sleeve gastrectomy
Who cannot join
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the EOI Plane Block area
- Advanced hepatic or renal failure
- Chronic pain syndromes
- Alcohol or drug abuse
- Severe pulmonary and/or cardiovascular disease
- Psychiatric disorders
Trial locations and contacts
1 site in 1 country.
About this study
Official title: External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
The external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy.
Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.
Read the detailed description
Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
- Conditions
- Obesity, Analgesia, Postoperative Pain
- Being tested
- Intravenous morphine patient control device, External oblique intercostal plane block
- Medical subject headings
- Obesity, Agnosia, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intravenous morphine patient control deviceOther
24-hour morphine consumption will be recorded
External oblique intercostal plane blockOther
External oblique intercostal plane block will be administered before the surgery.
| Study group | Role | What they receive |
|---|---|---|
| Control group | Active comparator | The patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia Receives: Other: Intravenous morphine patient control device |
| External oblique intercostal plane block group | Active comparator | The patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia Receives: Other: Intravenous morphine patient control device; Other: External oblique intercostal plane block |
What is being measured
The primary outcome is the main question the study is designed to answer.
Morphine consumption
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
Measured: Postoperative 24 hours
Secondary outcomes (4)
Postoperative visual analog scale scores
Postoperative pain will be assessed using a visual analog scale (VAS) (from 0 = no pain to 10 = maximum possible pain) for the first 24 hours.
Measured: Postoperative 24 hours
Time to first rescue analgesic
The time for administration of first rescue analgesic will be recorded.
Measured: postoperative 24 hours
Rescue analgesic drug consumption
The amount of rescue analgesic in mg required by the patient will be recorded for the first 24 hours.
Measured: postoperative 24 hours
Incidence of postoperative nausea and vomiting
Number of patients developing postoperative nausea and vomiting will be recorded for the first 24 hours
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start23 Dec 2022
- Primary completion1 May 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Istinye 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istinye University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Sait Kavakli, M.D., Principal investigator, Istinye UniversityTaylan Sahin, M.D., Principal investigator, Istinye University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05663658
- Sponsor's protocol ID
- anestezi1
- Status last verified
- Jan 2023
- First submitted
- 15 Dec 2022
- Last updated
- 26 May 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Kavakli AS, Sahin T, Koc U, Karaveli A. Ultrasound-Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled, Patient and Observer-Blinded Study. Obes Surg. 2024 May;34(5):1505-1512. doi: 10.1007/s11695-024-07174-9. Epub 2024 Mar 18.
PubMed 38499943
Study at a glance
From the registry record, last updated by the sponsor on 26 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- External Oblique Intercostal Plane Block for Postoperative Analgesia in Obese Patients Undergoing Laparoscopic Sleeve Gastrectomy
- ClinicalTrials.gov ID
- NCT05663658
- Acronym / sponsor ID
- anestezi1
- Conditions
- Obesity, Analgesia, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Istinye UniversityUniversity, hospital or other
- Study start
- 23 Dec 2022 (actual)
- Primary completion
- 1 May 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 23 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 external oblique intercostal (EOI) plane block is a novel approach upper abdominal wall analgesia. The EOI plane block can provide dermatomal sensory blockade of T6-T10 at the anterior axillary line and T6-T9 at the midline. It may be used for postoperative analgesia in obese patients because it is superficial and rapidly identifiable and performed in the supine position. the aim of this study is to investigate the postoperative analgesic efficacy of external oblique intercostal plane block in obese patients undergoing laparoscopic sleeve gastrectomy.
Researchers will compare the external oblique intercostal plane block group with control group to see if the EOI plane block is effective for postoperative analgesia in patients undergoing sleeve gastrectomy.
Detailed description
Patients scheduled for elective laparoscopic sleeve gastrectomy will be separated into 2 groups: Control Group and External Oblique Intercostal Plane Block Group. Patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia. Patients in External Oblique Intercostal Plane Block Group will be performed bilateral External Oblique Intercostal Plane Block before the surgery and received patient controlled analgesia with morphine for postoperative analgesia. Morphine consumption for first postoperative 24 hours, visual analog scale scores, time to need for first rescue analgesia, amount of rescue analgesic drug, incidence of postoperative nausea and vomiting will be recorded.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control group | Active comparator | Other: Intravenous morphine patient control deviceThe patients in Control Group will be received patient controlled analgesia with morphine for postoperative analgesia |
| External oblique intercostal plane block group | Active comparator | Other: Intravenous morphine patient control device, Other: External oblique intercostal plane blockThe patients in external oblique intercostal plane block group will be received EOI plane block and patient controlled analgesia with morphine for postoperative analgesia |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age between 18 and 80 years
- Patients with American Society of Anesthesiology (ASA) physical status II-III
- Patients scheduled for a laparoscopic sleeve gastrectomy
Key exclusion criteria (8 listed)
- Allergy to local anesthetics
- Coagulopathy
- Skin infection at the EOI Plane Block area
- Advanced hepatic or renal failure
- Chronic pain syndromes
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 |
|---|---|---|
| Intravenous morphine patient control device24-hour morphine consumption will be recorded | Other | Control group, External oblique intercostal plane block group |
| External oblique intercostal plane blockExternal oblique intercostal plane block will be administered before the surgery. | Other | External oblique intercostal plane block group |
Primary outcome
Morphine consumption
Time frame: Postoperative 24 hours
The amount of morphine required by the patient and given by the device will be recorded for the first 24 hours.
4 secondary outcomes
Postoperative visual analog scale scores
Time frame: Postoperative 24 hours
Time to first rescue analgesic
Time frame: postoperative 24 hours
Rescue analgesic drug consumption
Time frame: postoperative 24 hours
Incidence of postoperative nausea and vomiting
Time frame: postoperative 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 26 May 2023.
- Derived from this study: PubMed 38499943Kavakli AS, Sahin T, Koc U, Karaveli A. Ultrasound-Guided External Oblique Intercostal Plane Block for Postoperative Analgesia in Laparoscopic Sleeve Gastrectomy: A Prospective, Randomized, Controlled, Patient and Observer-Blinded Study. Obes Surg. 2024 May;34(5):1505-1512. doi: 10.1007/s11695-024-07174-9. Epub 2024 Mar 18.
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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.
Ali Sait Kavakli, M.D. principal investigator
Istinye University
Taylan Sahin, M.D. principal investigator
Istinye 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 External oblique intercostal plane block in people with Obesity and Analgesia, run by Istinye 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 3 inclusion and 8 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 26 May 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?
Morphine consumption (time frame: Postoperative 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 NCT05663658, which also lists 1 linked publication.
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 26 May 2023.