Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05284695
Other study ID # Cosarcan4
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 1, 2019
Est. completion date December 31, 2021

Study information

Verified date March 2022
Source V.K.V. American Hospital, Istanbul
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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]. 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.


Recruitment information / eligibility

Status Completed
Enrollment 113
Est. completion date December 31, 2021
Est. primary completion date December 31, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Intervention

Procedure:
Bariatric surgery
Patients undergoing elective bariatric surgery

Locations

Country Name City State
Turkey American Hsopital Istanbul

Sponsors (1)

Lead Sponsor Collaborator
V.K.V. American Hospital, Istanbul

Country where clinical trial is conducted

Turkey, 

References & Publications (5)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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 an — View Citation

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. Review. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary postoperative analgesia Postoperative pain assessment of patients will be made with a numeric rating scale (NRS). Postoperative opioid consumption will be examined 0 - 24 hours
See also
  Status Clinical Trial Phase
Recruiting NCT05650307 - CV Imaging of Metabolic Interventions
Not yet recruiting NCT05536466 - The Influence of Having Bariatric Surgery on the Pharmacokinetics, Safety and Efficacy of the Novel Non-nucleoside Reverse Transcriptase Inhibitor Doravirine N/A
Active, not recruiting NCT04583683 - Effects of Very Low Calorie Diet vs Metabolic Surgery on Weight Loss and Obesity Comorbidities N/A
Completed NCT04099654 - The Effect of Core Stabilization Exercise Program in Obese Subjects Awaiting Bariatric Surgery N/A
Completed NCT03809182 - Effect of Dexmedetomidine on Postoperative Glucose and Insulin Levels. Phase 4
Completed NCT03638843 - Endoscopic Gastric Mucosal Devitalization (GMD) as a Primary Obesity Therapy - Part 2 N/A
Withdrawn NCT05845359 - Intraoperative Methadone for Postoperative Pain Control Phase 4
Not yet recruiting NCT04343040 - Perioperative Evaluation of Glucose Profile Using Continuous Glucose Monitoring System in Glucose Intolerant Patients N/A
Withdrawn NCT03095404 - Intravenous Lidocaine for Post-Operative Pain Control in Patients Undergoing Bariatric Bowel Surgery Early Phase 1
Recruiting NCT03100292 - Korean OBEsity Surgical Treatment Study N/A
Active, not recruiting NCT04357119 - Common Limb Length in One-anastomosis Gastric Bypass N/A
Completed NCT03210207 - Gastric Plication in Mexican Patients N/A
Completed NCT04883268 - Focusing on Body Functionality After Bariatric Surgery N/A
Completed NCT02300168 - Neuromuscular Blockade: Outcome and Recovery for Laparoscopic Bariatric Surgery N/A
Unknown status NCT01264120 - The Impact of a Bariatric Rehabilitation Service on Patient Outcomes N/A
Recruiting NCT03972319 - Omega-3 Supplementation for LIver VolumE Reduction Study (OLIVER) Study Early Phase 1
Terminated NCT04626232 - Comparison of the Sleeve Gastrectomy Technique With a Nissen Fundoplication Added to the Conventional Sleeve Gastrectomy Technique in Morbidly Obese Patients N/A
Completed NCT03643783 - Impact of Plasma Soluble Prorenin Receptor in Obese and Type 2 Diabetic Patients
Completed NCT04219852 - Contraception and Bariatric Surgery: Evaluation of Contraception and Contraceptive Knowledge of Women Undergoing Bariatric Surgery at the University Hospital of Reims
Recruiting NCT05570474 - Effect of Protein Supplementation on Fat Free Mass Preservation After Bariatric Surgery N/A