NCT02775474

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
32

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 12, 2016

Completed
5 days until next milestone

First Posted

Study publicly available on registry

May 17, 2016

Completed
15 days until next milestone

Study Start

First participant enrolled

June 1, 2016

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2017

Completed
Last Updated

January 26, 2017

Status Verified

January 1, 2017

Enrollment Period

7 months

First QC Date

May 12, 2016

Last Update Submit

January 25, 2017

Conditions

Pain, PostoperativeChronic Pain

Keywords

MethadonePain, PostoperativeChronic PainBariatric Surgery

Outcome Measures

Primary Outcomes (1)

  • Postoperative Pain

    Postoperative pain will be evaluated using a verbal numerical pain scale (ranging from 0 to 10)

    Until 3 months postoperatively

Secondary Outcomes (3)

  • Postoperative opioid consumption

    Until 3 months postoperatively

  • Side effects

    Until 3 months postoperatively

  • Chronic postoperative pain

    3 months postoperatively

Study Arms (2)

Methadone

EXPERIMENTAL

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: Use of Intraoperative Intravenous Methadone

Fentanyl

ACTIVE COMPARATOR

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

Drug: Use of Intraoperative Intravenous Fentanyl

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

Also known as: Methadone
Methadone
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

Also known as: Methadone
Fentanyl

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Open bariatric surgery
  • No contraindications for any drugs used during the trial
  • Read, understood and signed the informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital das Clínicas da FMUSP

São Paulo, São Paulo, 05403-000, Brazil

Location

Related Publications (11)

  • Gourlay GK, Wilson PR, Glynn CJ. Methadone produces prolonged postoperative analgesia. Br Med J (Clin Res Ed). 1982 Feb 27;284(6316):630-1. doi: 10.1136/bmj.284.6316.630. No abstract available.

    PMID: 6802264BACKGROUND

  • Shaiova L, Berger A, Blinderman CD, Bruera E, Davis MP, Derby S, Inturrisi C, Kalman J, Mehta D, Pappagallo M, Perlov E. Consensus guideline on parenteral methadone use in pain and palliative care. Palliat Support Care. 2008 Jun;6(2):165-76. doi: 10.1017/S1478951508000254.

    PMID: 18501052BACKGROUND

  • Toombs JD, Kral LA. Methadone treatment for pain states. Am Fam Physician. 2005 Apr 1;71(7):1353-8.

    PMID: 15832538BACKGROUND

  • Kharasch ED. Intraoperative methadone: rediscovery, reappraisal, and reinvigoration? Anesth Analg. 2011 Jan;112(1):13-6. doi: 10.1213/ANE.0b013e3181fec9a3. No abstract available.

    PMID: 21173206BACKGROUND

  • Gourlay GK, Willis RJ, Wilson PR. Postoperative pain control with methadone: influence of supplementary methadone doses and blood concentration--response relationships. Anesthesiology. 1984 Jul;61(1):19-26.

    PMID: 6742480BACKGROUND

  • Inturrisi CE. Pharmacology of methadone and its isomers. Minerva Anestesiol. 2005 Jul-Aug;71(7-8):435-7.

    PMID: 16012416BACKGROUND

  • Gottschalk A, Durieux ME, Nemergut EC. Intraoperative methadone improves postoperative pain control in patients undergoing complex spine surgery. Anesth Analg. 2011 Jan;112(1):218-23. doi: 10.1213/ANE.0b013e3181d8a095. Epub 2010 Apr 24.

    PMID: 20418538BACKGROUND

  • 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.

    PMID: 22063370BACKGROUND

  • 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.

    PMID: 1609941BACKGROUND

  • 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.

    PMID: 2039637BACKGROUND

  • 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.

    PMID: 15082974RESULT

MeSH Terms

Conditions

Pain, PostoperativeChronic Pain

Interventions

Methadone

Condition Hierarchy (Ancestors)

Postoperative ComplicationsPathologic ProcessesPathological Conditions, Signs and SymptomsPainNeurologic ManifestationsSigns and Symptoms

Intervention Hierarchy (Ancestors)

KetonesOrganic Chemicals

Study Officials

  • Claudia Palmeira, MD, PhD

    University of Sao Paulo General Hospital

    STUDY CHAIR

  • Hazem Ashmawi, MD, PhD

    University of Sao Paulo General Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
MD

Study Record Dates

First Submitted

May 12, 2016

First Posted

May 17, 2016

Study Start

June 1, 2016

Primary Completion

January 1, 2017

Study Completion

January 1, 2017

Last Updated

January 26, 2017

Record last verified: 2017-01

Locations

BR(1)