Obesity Clinical Trial
Official title:
Comparison of the Efficacy of Ultrasound-guided Erector Spinae Plane Block for Postoperative Analgesia in Patients Undergoing Laparoscopic Bariatric Surgery
NCT number | NCT04189289 |
Other study ID # | 21/16 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | December 3, 2019 |
Est. completion date | April 6, 2020 |
Verified date | December 2019 |
Source | Antalya Training and Research Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The aim of the study is to evaluate the effect of erector spinae plane (ESP) block on postoperative analgesic consumption in patients undergoing laparoscopic bariatric surgery
Status | Completed |
Enrollment | 54 |
Est. completion date | April 6, 2020 |
Est. primary completion date | April 3, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - elective bariatric surgery - American Society of Anesthesiology (ASA) II-III - 18 - 65 years - body mass index (BMI) 40-60 kg/m2 Exclusion Criteria: - ASA =4 - under 18 years of age or over 65 years of age - declining to give written informed consent - have neurological and/or psychiatric disorders - cooperation cannot be established - accompanying laparoscopic cholecystectomy or paraumbilical hernia repair - history of bariatric surgery - the block cannot be applied due to bleeding disorders or localized skin infection at the injection site - with hepatic, neuromuscular, cardiac and/or renal failure - history of allergy to the local anesthetics - patients undergoing open surgery |
Country | Name | City | State |
---|---|---|---|
Turkey | Antalya Training and Research Hospital, Department of Anesthesiology and Reanimation | Antalya |
Lead Sponsor | Collaborator |
---|---|
Antalya Training and Research Hospital |
Turkey,
Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581. — View Citation
Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | analgesia consumption | postoperative 24 hours | 24 hours | |
Secondary | Postoperative Numeric Rating Scale (NRS) score | postoperative pain assessment will be performed using NRS score (NRS 0=no pain, NRS 10= most severe possible). | postoperative 0, 1, 3, 6, 12, 24 hours |
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