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Pain, PostoperativePhase 4NCT02775474

Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

A Phase 4 study testing Use of Intraoperative Intravenous Methadone and Use of Intraoperative Intravenous Fentanyl in people with Pain, Postoperative and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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… Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Pain, Postoperative, Chronic Pain
What is being tested?
Use of Intraoperative Intravenous Methadone and Use of Intraoperative Intravenous Fentanyl
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
32 participants
Where
1 siteBrazil
Study dates
Jun 2016to Jan 2017
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

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

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Brazil1 site

  • Hospital das Clínicas da FMUSP

    São Paulo, São Paulo, 05403-000

Other trials in Brazil

About this study

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.

Read the 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.

Being tested
Use of Intraoperative Intravenous Methadone, Use of Intraoperative Intravenous Fentanyl
Keywords
Methadone, Pain, Postoperative, Chronic Pain, Bariatric Surgery
Medical subject headings
Pain, Postoperative, Chronic Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Use of Intraoperative Intravenous MethadoneDrug

    Also called 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

  • Use of Intraoperative Intravenous FentanylDrug

    Also called Methadone

    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

Study groups in NCT02775474
Study groupRoleWhat they receive
MethadoneExperimentalMethadone used as anesthesia opioid: induction with 0,15 mg / kg intravenous methadone. Boluses of 0,05 mg / kg intravenous methadone as needed intraoperatively
Receives: Drug: Use of Intraoperative Intravenous Methadone
FentanylActive comparatorFentanyl used as anesthesia opioid: induction with 6 mcg / kg intravenous fentanyl. Boluses of 2 mug / kg intravenous fentanyl as needed intraoperatively
Receives: Drug: Use of Intraoperative Intravenous Fentanyl

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Pain

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

    Measured: Until 3 months postoperatively

Secondary outcomes (3)

  1. Postoperative opioid consumption

    Postoperative opioid consumption will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months

    Measured: Until 3 months postoperatively

  2. 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

    Measured: Until 3 months postoperatively

  3. 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

    Measured: 3 months postoperatively

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 May 2016 (estimated)
  2. Study startJun 2016
  3. Primary completionJan 2017
  4. Study completionJan 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02775474
Sponsor's protocol ID
52792616.9.0000.0068
Status last verified
Jan 2017
First submitted
12 May 2016
Last updated
26 Jan 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 6802264

  • 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.

    PubMed 18501052

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

    PubMed 15832538

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

    PubMed 21173206

  • 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.

    PubMed 6742480

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

    PubMed 16012416

  • 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.

    PubMed 20418538

  • 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.

    PubMed 22063370

  • 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.

    PubMed 1609941

  • 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.

    PubMed 2039637

  • 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.

    PubMed 15082974

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Use of Intraoperative Intravenous Methadone and Use of Intraoperative Intravenous Fentanyl in people with Pain, Postoperative and Chronic Pain, run by University of Sao Paulo General Hospital at 1 site in Brazil.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Jan 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Pain (time frame: Until 3 months postoperatively). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02775474, which also lists 11 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.

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