Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

NCT ID: NCT02775474

Last Updated: 2017-01-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 32 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-06-30
• Study Completion Date: 2017-01-31

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.

Conditions

Pain, Postoperative; Chronic Pain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: QUADRUPLE

Study Groups

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

Group Type: EXPERIMENTAL

Use of Intraoperative Intravenous Methadone

Intervention Type: DRUG

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

Fentanyl

Fentanyl used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively

Group Type: ACTIVE_COMPARATOR

Use of Intraoperative Intravenous Fentanyl

Intervention Type: DRUG

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

Interventions

Use of Intraoperative Intravenous 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

Intervention Type: DRUG

Use of Intraoperative Intravenous 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

Intervention Type: DRUG

Other Intervention Names

Methadone; Methadone

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University of Sao Paulo General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Felipe Chiodini Machado

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claudia Palmeira, MD, PhD

Role: STUDY_CHAIR

University of Sao Paulo General Hospital

Hazem Ashmawi, MD, PhD

Role: STUDY_DIRECTOR

University of Sao Paulo General Hospital

Locations

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, Brazil

Countries

Brazil

References

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: BACKGROUND

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Reference Type: RESULT

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Other Identifiers

52792616.9.0000.0068

Identifier Type: -

Identifier Source: org_study_id