Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

Phase 4

Completed

• Conditions: Pain, Postoperative; Chronic Pain
• Interventions: Drug: Use of Intraoperative Intravenous Methadone; Drug: Use of Intraoperative Intravenous Fentanyl

• Registration Number: NCT02775474
• Lead Sponsor: University of Sao Paulo General Hospital

Brief Summary

The recent increase in obesity has led to an increase in the need for bariatric surgery. In this group of patients the postoperative pain management is of vital importance. One strategy to improve postoperative analgesia is the use of intraoperative methadone, specially in those patients which regional anesthesia is not feasible. There is evidence that the use of intraoperative methadone can lead to a analgesia lasting 24 to 36 hours, while not associated with increased side effects when compared to other opioids with short or intermediate duration of action. In this study the investigators will evaluate the efficacy of intraoperative methadone in reducing postoperative pain and opioid consumption.

Detailed Description

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.

Study Timeline

• Study First Submitted: 2016-05-12
• Study First Submitted QC: 2016-05-16
• Study First Posted: 2016-05-17
• Study Start: 2016-06
• Status Verified: 2017-01
• Primary Completion: 2017-01
• Study Completion: 2017-01
• Last Update Submitted: 2017-01-25
• Last Update Posted: 2017-01-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 32

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Methadone	Use of Intraoperative Intravenous 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
Fentanyl	Use of Intraoperative Intravenous Fentanyl	Fentanyl used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively

Primary Outcome Measures

Name	Time	Method
Postoperative Pain	Until 3 months postoperatively	Postoperative pain will be evaluated using a verbal numerical pain scale (ranging from 0 to 10)

Secondary Outcome Measures

Name	Time	Method
Chronic postoperative pain	3 months postoperatively	Patients will be evaluated for chronic pain 3 months postoperatively through a questionnaire which includes questions about numerical verbal scale of pain in the last three months, analgesic consumption and satisfaction with analgesia regimen
Side effects	Until 3 months postoperatively	Nausea, vomiting, itching, urinary retention, respiratory depression, sedation will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months
Postoperative opioid consumption	Until 3 months postoperatively	Postoperative opioid consumption will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months

Trial Locations

Locations (1)

Hospital das Clínicas da FMUSP; 🇧🇷 Sao Paulo, Brazil