- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05284695
The EFFICIENCY of FASCIAL PLANE BLOCKS in BARIATRIC SURGERY
March 26, 2025 updated by: Sami Kaan Coşarcan, V.K.V. American Hospital, Istanbul
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.
Study Overview
Status
Completed
Intervention / Treatment
Study Type
Observational
Enrollment (Actual)
113
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Istanbul, Turkey, 34365
- American Hsopital
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
Fascial plane blocks and postoperative analgesia efficacy were investigated in bariatric surgery patients.
Description
Inclusion Criteria:
- Patients undergoing elective bariatric surgery
Exclusion Criteria:
- Patients with a history of cerebrovascular events
- Alzheimer's and dementia
- inadequate cognitive functions
- history of chronic pain
- long-term opioid therapy
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
Intervention / Treatment |
|---|---|
|
TAP + RB
transversus abdominis plane block and rectus sheath block
|
Patients undergoing elective bariatric surgery
|
|
ESPB
Erector spinae plane block
|
Patients undergoing elective bariatric surgery
|
|
EOI
External oblique intercostal block
|
Patients undergoing elective bariatric surgery
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
0 - 24 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: sami kaan coşarcan, American Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Frauenknecht 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.
- Subramani 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.
- Chin 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.
- Cosarcan 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.
- 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. Erratum In: JAMA Surg. 2019 Mar 1;154(3):272. doi: 10.1001/jamasurg.2018.5476.
- Park 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
January 1, 2019
Primary Completion (Actual)
December 31, 2021
Study Completion (Actual)
December 31, 2021
Study Registration Dates
First Submitted
February 25, 2022
First Submitted That Met QC Criteria
March 8, 2022
First Posted (Actual)
March 17, 2022
Study Record Updates
Last Update Posted (Actual)
April 2, 2025
Last Update Submitted That Met QC Criteria
March 26, 2025
Last Verified
March 1, 2022
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Cosarcan4
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.