ObesityNCT05614921
External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy
A study testing ultrasound guided external oblique intercostal plane block and Wound infiltration in people with Obesity, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
The morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago. Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Obesity
- What is being tested?
- ultrasound guided external oblique intercostal plane block and Wound infiltration
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Nov 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 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 Obesity surgery
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. Wound Infiltration for Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study
The morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago.
Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged postoperative pain may cause early ambulation and delay performing deep breathing exercises.
Read more
Using regional anesthetic techniques results in less opioid use and better pain management. External oblique internal costal block; It is a new block that provides dermatomal sensory blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be used as part of multimodal analgesia in laparoscopic cases.
There is no study in the literature regarding the use of external oblique plane block in bariatric surgery yet.
- Conditions
- Obesity
- Being tested
- ultrasound guided external oblique intercostal plane block, Wound infiltration
- Medical subject headings
- Obesity
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 30 ml local anesthetic each side
Wound infiltrationOther
5 ml local anesthetic for each trocar 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 |
| Wound infiltration | Active comparator | Wound infiltration to trocar sites before surgery Receives: Other: Wound infiltration |
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 posted14 Nov 2022
- Study start15 Nov 2022
- Primary completion1 Apr 2023
- Study completion15 May 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies 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
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Collaborators
- Erzurum City Hospital, Bursa City Hospital
- Responsible party
- Principal investigator, Ali Ahiskalioglu, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05614921
- Sponsor's protocol ID
- atauniobesity
- Status last verified
- May 2023
- First submitted
- 7 Nov 2022
- Last updated
- 31 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.
PubMed 35249704Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.
PubMed 35776242
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound Guided External Oblique Intercostal Plane Block vs. Wound Infiltration for Laparoscopic Sleeve Gastrectomy: Prospective Randomized Study
- ClinicalTrials.gov ID
- NCT05614921
- Acronym / sponsor ID
- atauniobesity
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Collaborators
- Erzurum City Hospital, Bursa City Hospital
- Study start
- 15 Nov 2022 (actual)
- Primary completion
- 1 Apr 2023 (actual)
- Study completion
- 15 May 2023 (actual)
- First posted
- 14 Nov 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 morbidity and mortality associated with being overweight or obese have been known to the medical profession since Hippocrates, more than 2500 years ago.
Pain that develops following bariatric surgery may prolong recovery time. Most morbidly obese patients have obstructive sleep apnea and cardiac comorbidities. In these patients, prolonged postoperative pain may cause early ambulation and delay performing deep breathing exercises.
Using regional anesthetic techniques results in less opioid use and better pain management. External oblique internal costal block; It is a new block that provides dermatomal sensory blockage involving T6-T10 in the anterior axillary line and T6-T9 in the midline. It can be used as part of multimodal analgesia in laparoscopic cases.
There is no study in the literature regarding the use of external oblique plane block in bariatric surgery yet.
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 |
| Wound infiltration | Active comparator | Other: Wound infiltrationWound infiltration to trocar sites before surgery |
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 Obesity surgery
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 30 ml local anesthetic each side | Other | External oblique intercostal plane block |
| Wound infiltration5 ml local anesthetic for each trocar side | Other | Wound infiltration |
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 31 May 2023.
- Background: PubMed 35249704White L, Ji A. External oblique intercostal plane block for upper abdominal surgery: use in obese patients. Br J Anaesth. 2022 May;128(5):e295-e297. doi: 10.1016/j.bja.2022.02.011. Epub 2022 Mar 3. No abstract available.
- Background: PubMed 35776242Cosarcan SK, Yavuz Y, Dogan AT, Ercelen O. Can Postoperative Pain Be Prevented in Bariatric Surgery? Efficacy and Usability of Fascial Plane Blocks: a Retrospective Clinical Study. Obes Surg. 2022 Sep;32(9):2921-2929. doi: 10.1007/s11695-022-06184-9. Epub 2022 Jul 1.
- 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 Wound infiltration in people with Obesity, 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 31 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?
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 NCT05614921, which also lists 2 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 31 May 2023.