At a glance

ClinicalIndex Comparison Record

Phase 4Completed· 32 enrolled

Drug / intervention

Use of Intraoperative Intravenous Methadone +1 moredrug

Likely dose

Use of Intraoperative Intravenous Methadone 0,15 mgfrom record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02775474

NCT02775474Phase 4Completed

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Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

University of Sao Paulo General Hospital·interventional·Posted May 17, 2016·Updated Jan 26, 2017

In Brief

A Phase 4 clinical trial evaluating Use of Intraoperative Intravenous Methadone and Use of Intraoperative Intravenous Fentanyl for Pain, Postoperative and Chronic Pain. Completed, enrolled 32 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsPain, Postoperative, Chronic Pain

CountriesBrazil

Collaborators--

Timeline

Phase 4CompletedFinished

2017201820192020202120222023202420252026

First PostedMay 2016

Enrollment StartJun 2016

Primary CompletionJan 2017

TodayJul 2026

First PostedMay 17, 2016

Enrollment StartJun 1, 2016

Primary CompletionJan 1, 2017

TodayJul 2, 2026

Enrollment to primary: 7 monthsPosted 10.1 years ago

Interventions

Use of Intraoperative Intravenous Methadonedrug

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

Use of Intraoperative Intravenous Fentanyldrug

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