Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

Chronic Pain Clinical Trial

Official title:

Does Intraoperative Methadone Prevent Postoperative Pain in Bariatric Surgery?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02775474
• Other study ID #: 52792616.9.0000.0068
• Status: Completed
• Phase: Phase 4
• First received: May 12, 2016
• Last updated: January 25, 2017
• Start date: June 2016
• Est. completion date: January 2017

Study information

• Verified date: January 2017
• Source: University of Sao Paulo General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 32
• Est. completion date: January 2017
• Est. primary completion date: January 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Pain
• Pain, Postoperative

Intervention

Drug:
• 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
• 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

Locations

Country	Name	City	State
Brazil	Hospital das Clínicas da FMUSP	Sao Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo General Hospital

Country where clinical trial is conducted

Brazil, 

References & Publications (11)

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. — View 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. — View Citation

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. — View Citation

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. — View Citation

Gourlay GK, Wilson PR, Glynn CJ. Methadone produces prolonged postoperative analgesia. Br Med J (Clin Res Ed). 1982 Feb 27;284(6316):630-1. — View Citation

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

Kharasch ED. Intraoperative methadone: rediscovery, reappraisal, and reinvigoration? Anesth Analg. 2011 Jan;112(1):13-6. doi: 10.1213/ANE.0b013e3181fec9a3. — View Citation

Richlin DM, Reuben SS. Postoperative pain control with methadone following lower abdominal surgery. J Clin Anesth. 1991 Mar-Apr;3(2):112-6. — View Citation

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. Review. Erratum in: Palliat Support Care. 2008 Sep;6(3):321. — View Citation

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

* Note: There are 11 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Pain	Postoperative pain will be evaluated using a verbal numerical pain scale (ranging from 0 to 10)	Until 3 months postoperatively
Secondary	Postoperative opioid consumption	Postoperative opioid consumption will be evaluated at fixed postoperative times: 2h, 6h, 24h, 48h, 72h and 3 months	Until 3 months postoperatively
Secondary	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	Until 3 months postoperatively
Secondary	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	3 months postoperatively