Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?
關鍵詞
抽象
描述
Despite recent developments in postoperative pain control, many patients still suffer from moderate to severe pain after surgery. It is estimated that postoperative severe pain occurs in 20 to 40% of surgical procedures. With the recent increase in obesity incidence in the last years, the need for bariatric surgical intervention is greater. The management of postoperative pain in obese patients is particularly important, since this population have increased susceptibility to cardiovascular, pulmonary and thromboembolic perioperatively.
One of the strategies to improve pain management in the perioperative period is the intraoperative use of intravenous methadone, given its pharmacokinetic profile, specially in those patients in which regional anesthesia is contraindicated. Methadone is an opioid μ (MOR) receptor agonist, also a glutamate antagonist by blocking the N-methyl-D-aspartate (NMDA) receptor and a reuptake of serotonin and noradrenaline inhibitor. Intraoperative analgesia generated by administration of 20 to 30 mg methadone can last 24 to 36 hours. There is also evidence that methadone at 0.2 to 0.3 mg / kg is not associated with an increased incidence of side effects compared to other opioids with short or intermediate duration of action, such as fentanyl, sufentanyl and morphine.
The aim of this study is to evaluate the efficacy of intraoperative methadone in reducing postoperative pain and opioid consumption in patients undergoing open gastroplasty with or without associated Roux Y. Patients will undergo standardized general anesthesia, and the opioid used in anesthesia induction is methadone 0.15 mg / kg fentanyl or 6 mcg / kg bolus with additional if necessary. After extubation a intravenous morphine patient controlled analgesia device will be already available in the operating room. Groups will be compared regarding opioid consumption, pain scores, side effects, patient satisfaction and development of chronic postoperative pain.
日期
| 最後驗證: | 12/31/2016 |
| 首次提交: | 05/11/2016 |
| 提交的預估入學人數: | 05/15/2016 |
| 首次發布: | 05/16/2016 |
| 上次提交的更新: | 01/24/2017 |
| 最近更新發布: | 01/25/2017 |
| 實際學習開始日期: | 05/31/2016 |
| 預計主要完成日期: | 12/31/2016 |
| 預計完成日期: | 12/31/2016 |
狀況或疾病
干預/治療
Drug: Methadone
Drug: Fentanyl
相
手臂組
| 臂 | 干預/治療 |
|---|---|
| Experimental: Methadone Methadone used as anesthesia opioid: induction with 0,15 mg / kg intravenous methadone. Boluses of 0,05 mg / kg intravenous methadone as needed intraoperatively | Drug: Methadone The intervention group will be given intravenous methadone at a fixed induction dose (0,15 mg / kg) and intraoperative boluses as judged necessary by the anesthesiologist |
| Active Comparator: Fentanyl Fentanyl used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively | Drug: Fentanyl The active control group will be given intravenous fentanyl at a fixed induction dose (6 mg / kg) and intraoperative boluses as judged necessary by the anesthesiologist |
資格標準
| 有資格學習的年齡 | 18 Years 至 18 Years |
| 有資格學習的性別 | All |
| 接受健康志願者 | 是 |
| 標準 | Inclusion Criteria: - Open bariatric surgery - No contraindications for any drugs used during the trial - Read, understood and signed the informed consent Exclusion Criteria: - Laparoscopic bariatric surgery - Known allergy to any drugs used during the trial - Cardiovascular disease - Creatinine clearance lower than 60 mL/min/1.73 m2 - Chronic usage of opioids - History of personality disorder |
結果
主要結果指標
1. Postoperative Pain [Until 3 months postoperatively]
次要成果指標
1. Postoperative opioid consumption [Until 3 months postoperatively]
2. Side effects [Until 3 months postoperatively]
3. Chronic postoperative pain [3 months postoperatively]
