Regional Anesthesia MorbidityNCT05284695
THE EFFICIENCY OF FASCIAL PLANE BLOCKS IN BARIATRIC SURGERY
An observational study of Regional Anesthesia Morbidity and Post Operative Pain, run by V.K.V. American Hospital, Istanbul at 1 site in Turkey (Türkiye).
Trial summary
Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery [1]. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Regional Anesthesia Morbidity, Post Operative Pain, Bariatric Surgery Candidate
- What is being tested?
- Bariatric surgery
- Type of treatment
- Surgery or procedure
- How many people
- 113 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Fascial plane blocks and postoperative analgesia efficacy were investigated in bariatric surgery patients.
Who may be able to join
- Patients undergoing elective bariatric surgery
Who cannot join
- Patients with a history of cerebrovascular events
- Alzheimer's and dementia
- inadequate cognitive functions
- history of chronic pain
- long-term opioid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: CAN POSTOPERATIVE PAIN BE PREVENTED IN BARIATRIC SURGERY? EFFICACY AND USABILITY OF FASCIAL PLANE BLOCKS: A RETROSPECTIVE CLINICAL STUDY
Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery [1]. Opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. Providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgeryThe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (TAP), rectus sheath block (RB), the erector spinae plane block (ESPB) and the external oblique intercostal block (EOI). In this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at VKV American Hospital between January 2019 and December 2021 were reviewed retrospectively.
- Being tested
- Bariatric surgery
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bariatric surgeryProcedure or surgery
Patients undergoing elective bariatric surgery
| Study group | Role | What they receive |
|---|---|---|
| TAP + RB | transversus abdominis plane block and rectus sheath block Receives: Procedure: Bariatric surgery | |
| ESPB | Erector spinae plane block Receives: Procedure: Bariatric surgery | |
| EOI | External oblique intercostal block Receives: Procedure: Bariatric surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative analgesia
Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined
Measured: 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 posted17 Mar 2022
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Observational
- Observational model
- Case only
- Time perspective
- Retrospective
- Enrolment
- 113 participants (actual)
Sponsor and investigators
- Lead sponsor
- V.K.V. American Hospital, Istanbul
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sami Kaan Coşarcan, V.K.V. American Hospital, Istanbul
- Investigators
- sami kaan coşarcan, Study chair, American hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05284695
- Sponsor's protocol ID
- Cosarcan4
- Status last verified
- Mar 2022
- First submitted
- 25 Feb 2022
- Last updated
- 2 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
PubMed 28403427Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
PubMed 28085788Park CH, Nam SJ, Choi HS, Kim KO, Kim DH, Kim JW, Sohn W, Yoon JH, Jung SH, Hyun YS, Lee HL; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Comparative Efficacy of Bariatric Surgery in the Treatment of Morbid Obesity and Diabetes Mellitus: a Systematic Review and Network Meta-Analysis. Obes Surg. 2019 Jul;29(7):2180-2190. doi: 10.1007/s11695-019-03831-6.
PubMed 31037599Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.
PubMed 29077813Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
PubMed 30802933Cosarcan 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 2 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- CAN POSTOPERATIVE PAIN BE PREVENTED IN BARIATRIC SURGERY? EFFICACY AND USABILITY OF FASCIAL PLANE BLOCKS: A RETROSPECTIVE CLINICAL STUDY
- ClinicalTrials.gov ID
- NCT05284695
- Acronym / sponsor ID
- Cosarcan4
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 113 participants (actual)
- Lead sponsor
- V.K.V. American Hospital, IstanbulUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 17 Mar 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.
Bariatric surgery effectively produces weight loss and reduces obesity-related comorbidities. Although it is mostly performed with minimally invasive techniques, the patients may still suffer from moderate-to-severe pain immediately after surgery [1]. Opioids remain the first choice for multimodal analgesia in the treatment of postoperative pain. Providing analgesia after bariatric surgery might be challenging due to a high prevalence of obstructive sleep apnea syndrome and the increased sensitivity to respiratory depression triggered by opioid overuse after surgeryThe most common plane block techniques utilized during laparoscopic bariatric surgery are transversus abdominis plane block (TAP), rectus sheath block (RB), the erector spinae plane block (ESPB) and the external oblique intercostal block (EOI). In this study, we have evaluated the auxiliary benefit of these various techniques in reduction of the postoperative in bariatric surgery. patients who had laparoscopic bariatric surgery at VKV American Hospital between January 2019 and December 2021 were reviewed retrospectively.
Study design
- Observational model
- Case only
- Time perspective
- Retrospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| TAP + RB | – | Procedure: Bariatric surgerytransversus abdominis plane block and rectus sheath block |
| ESPB | – | Procedure: Bariatric surgeryErector spinae plane block |
| EOI | – | Procedure: Bariatric surgeryExternal oblique intercostal block |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Fascial plane blocks and postoperative analgesia efficacy were investigated in bariatric surgery patients.
Key inclusion criteria (1 listed)
- Patients undergoing elective bariatric surgery
Key exclusion criteria (5 listed)
- Patients with a history of cerebrovascular events
- Alzheimer's and dementia
- inadequate cognitive functions
- history of chronic pain
- long-term opioid therapy
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 |
|---|---|---|
| Bariatric surgeryPatients undergoing elective bariatric surgery | Procedure or surgery | EOI, ESPB, TAP + RB |
Primary outcome
postoperative analgesia
Time frame: 0 - 24 hours
Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined
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 2 Apr 2025.
- Background: PubMed 28403427Brummett CM, Waljee JF, Goesling J, Moser S, Lin P, Englesbe MJ, Bohnert ASB, Kheterpal S, Nallamothu BK. New Persistent Opioid Use After Minor and Major Surgical Procedures in US Adults. JAMA Surg. 2017 Jun 21;152(6):e170504. doi: 10.1001/jamasurg.2017.0504. Epub 2017 Jun 21.
- Background: PubMed 28085788Chin KJ, McDonnell JG, Carvalho B, Sharkey A, Pawa A, Gadsden J. Essentials of Our Current Understanding: Abdominal Wall Blocks. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):133-183. doi: 10.1097/AAP.0000000000000545.
- Results publication: PubMed 31037599Park CH, Nam SJ, Choi HS, Kim KO, Kim DH, Kim JW, Sohn W, Yoon JH, Jung SH, Hyun YS, Lee HL; Korean Research Group for Endoscopic Management of Metabolic Disorder and Obesity. Comparative Efficacy of Bariatric Surgery in the Treatment of Morbid Obesity and Diabetes Mellitus: a Systematic Review and Network Meta-Analysis. Obes Surg. 2019 Jul;29(7):2180-2190. doi: 10.1007/s11695-019-03831-6.
- Results publication: PubMed 29077813Subramani Y, Nagappa M, Wong J, Patra J, Chung F. Death or near-death in patients with obstructive sleep apnoea: a compendium of case reports of critical complications. Br J Anaesth. 2017 Nov 1;119(5):885-899. doi: 10.1093/bja/aex341.
- Results publication: PubMed 30802933Frauenknecht J, Kirkham KR, Jacot-Guillarmod A, Albrecht E. Analgesic impact of intra-operative opioids vs. opioid-free anaesthesia: a systematic review and meta-analysis. Anaesthesia. 2019 May;74(5):651-662. doi: 10.1111/anae.14582. Epub 2019 Feb 25.
- Derived from this study: 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.
sami kaan coşarcan study chair
American hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Regional Anesthesia Morbidity and Post Operative Pain, run by V.K.V. American Hospital, Istanbul 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 5 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 2 Apr 2025. 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 analgesia (time frame: 0 - 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 NCT05284695, which also lists 6 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 2 Apr 2025.