Obesity Clinical Trial
Official title:
Comparison of Intravenous Ibuprofen and Erector Spinae Plane Block for Postoperative Pain Management After Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study
Verified date | December 2021 |
Source | Medipol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Laparoscopic sleeve gastrectomy (LSG) is defined as the first-step bariatric surgery for patients in the high surgical risk group. It has been shown that the laparoscopic approach has lower complication rates, shorter hospital stays, and earlier mobilization compared to open surgery. However, postoperative pain management is very important because it might cause major morbidity, especially pulmonary complications in the early postoperative period. The intravenous (IV) form of ibuprofen has been used in the pain treatment since 2009. It has been shown to be effective, safe and with less adverse effects in the treatment of postoperative pain. It has been reported that ibuprofen provides effective postoperative pain management after LSG surgery. The ultrasound (US) guided erector spina plane block (ESPB) is a novel interfacial plan block defined by Forero et al. ESPB provides thoracic analgesia at T5 level, abdominal analgesia at T7-9 level. In the literature, it has been reported that ESPB provides effective analgesia after LSG surgery. The aim of this study is to compare US-guided ESPB and IV ibuprofen for postoperative analgesia management after LSG surgery.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | November 30, 2020 |
Est. primary completion date | November 30, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | Inclusion Criteria: - American Society of Anesthesiologists (ASA) classification I-II - Scheduled for laparoscopic sleeve gastrectomy surgery under general anesthesia Exclusion Criteria: - history of bleeding diathesis, - receiving anticoagulant treatment, - known local anesthetics and opioid allergy, - infection of the skin at the site of the needle puncture, - pregnancy or lactation, - patients who do not accept the procedure |
Country | Name | City | State |
---|---|---|---|
Turkey | Istanbul Medipol University Hospital | Istanbul | Bagcilar |
Lead Sponsor | Collaborator |
---|---|
Medipol University |
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
Ciftci B, Ekinci M, Celik EC, Kaciroglu A, Karakaya MA, Demiraran Y, Ozdenkaya Y. Comparison of Intravenous Ibuprofen and Paracetamol for Postoperative Pain Management after Laparoscopic Sleeve Gastrectomy. A Randomized Controlled Study. Obes Surg. 2019 Mar;29(3):765-770. doi: 10.1007/s11695-018-3613-1. — View Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Opioid consumption | The primary aim is to compare postoperative opioid consumption | Changes from baseline opioid consumption at postoperative 1, 2, 4, 8, 16 and 24 hours. | |
Secondary | Pain scores (Visual analogue scores-VAS) | Postoperative pain assessment will be performed using the VAS score (0 = no pain, 10 = the most severe pain felt). The VAS scores at rest and during mobilization will be recorded | Changes from baseline pain scores at postoperative 1, 2, 4, 8, 16 and 24 hours. |
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