Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?
Primary Purpose
Pain, Postoperative, Chronic Pain
Status
Completed
Phase
Phase 4
Locations
Brazil
Study Type
Interventional
Intervention
Use of Intraoperative Intravenous Methadone
Use of Intraoperative Intravenous Fentanyl
Sponsored by
About this trial
This is an interventional prevention trial for Pain, Postoperative focused on measuring Methadone, Pain, Postoperative, Chronic Pain, Bariatric Surgery
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
Sites / Locations
- Hospital das Clínicas da FMUSP
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Methadone
Fentanyl
Arm Description
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 used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively
Outcomes
Primary Outcome Measures
Postoperative Pain
Postoperative pain will be evaluated using a verbal numerical pain scale (ranging from 0 to 10)
Secondary Outcome Measures
Postoperative opioid consumption
Postoperative opioid consumption will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months
Side effects
Nausea, vomiting, itching, urinary retention, respiratory depression, sedation will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months
Chronic postoperative pain
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
Full Information
NCT ID
NCT02775474
First Posted
May 12, 2016
Last Updated
January 25, 2017
Sponsor
University of Sao Paulo General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02775474
Brief Title
Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?
Official Title
Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?
Study Type
Interventional
2. Study Status
Record Verification Date
January 2017
Overall Recruitment Status
Completed
Study Start Date
June 2016 (undefined)
Primary Completion Date
January 2017 (Actual)
Study Completion Date
January 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Sao Paulo General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Chronic Pain
Keywords
Methadone, Pain, Postoperative, Chronic Pain, Bariatric Surgery
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
32 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Methadone
Arm Type
Experimental
Arm Description
Methadone used as anesthesia opioid: induction with 0,15 mg / kg intravenous methadone. Boluses of 0,05 mg / kg intravenous methadone as needed intraoperatively
Arm Title
Fentanyl
Arm Type
Active Comparator
Arm Description
Fentanyl used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively
Intervention Type
Drug
Intervention Name(s)
Use of Intraoperative Intravenous Methadone
Other Intervention Name(s)
Methadone
Intervention Description
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
Intervention Name(s)
Use of Intraoperative Intravenous Fentanyl
Other Intervention Name(s)
Methadone
Intervention Description
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
Primary Outcome Measure Information:
Title
Postoperative Pain
Description
Postoperative pain will be evaluated using a verbal numerical pain scale (ranging from 0 to 10)
Time Frame
Until 3 months postoperatively
Secondary Outcome Measure Information:
Title
Postoperative opioid consumption
Description
Postoperative opioid consumption will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months
Time Frame
Until 3 months postoperatively
Title
Side effects
Description
Nausea, vomiting, itching, urinary retention, respiratory depression, sedation will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months
Time Frame
Until 3 months postoperatively
Title
Chronic postoperative pain
Description
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
Time Frame
3 months postoperatively
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claudia Palmeira, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Hazem Ashmawi, MD, PhD
Organizational Affiliation
University of Sao Paulo General Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Hospital das Clínicas da FMUSP
City
Sao Paulo
ZIP/Postal Code
05403-000
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
6802264
Citation
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Results Reference
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PubMed Identifier
18501052
Citation
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Results Reference
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PubMed Identifier
15832538
Citation
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Results Reference
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PubMed Identifier
21173206
Citation
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Results Reference
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PubMed Identifier
6742480
Citation
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Results Reference
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PubMed Identifier
16012416
Citation
Inturrisi CE. Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):435-7.
Results Reference
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PubMed Identifier
20418538
Citation
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Results Reference
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PubMed Identifier
22063370
Citation
Udelsmann A, Maciel FG, Servian DC, Reis E, de Azevedo TM, Melo Mde S. Methadone and morphine during anesthesia induction for cardiac surgery. Repercussion in postoperative analgesia and prevalence of nausea and vomiting. Rev Bras Anestesiol. 2011 Nov-Dec;61(6):695-701. doi: 10.1016/S0034-7094(11)70078-2. English, Multiple languages.
Results Reference
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PubMed Identifier
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Citation
Chui PT, Gin T. A double-blind randomised trial comparing postoperative analgesia after perioperative loading doses of methadone or morphine. Anaesth Intensive Care. 1992 Feb;20(1):46-51. doi: 10.1177/0310057X9202000109.
Results Reference
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PubMed Identifier
2039637
Citation
Richlin DM, Reuben SS. Postoperative pain control with methadone following lower abdominal surgery. J Clin Anesth. 1991 Mar-Apr;3(2):112-6. doi: 10.1016/0952-8180(91)90007-a.
Results Reference
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Citation
Fernandez AZ Jr, Demaria EJ, Tichansky DS, Kellum JM, Wolfe LG, Meador J, Sugerman HJ. Multivariate analysis of risk factors for death following gastric bypass for treatment of morbid obesity. Ann Surg. 2004 May;239(5):698-702; discussion 702-3. doi: 10.1097/01.sla.0000124295.41578.ab.
Results Reference
result
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Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?
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