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WithdrawnNCT01125059Updated Apr 22, 2015

Methadone Versus Placebo in Spine Fusion

An interventional study of Methadone and Saline in Postoperative Pain, sponsored by Northwestern University. Withdrawn at 1 site in United States. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2015-04-22.

Sponsored by Northwestern University · Not applicable, Interventional, and Treatment

Why this study was withdrawn
Unable to fulfill recruitment
Phase
Not applicable
Study type
Interventional
Enrollment
0
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

What is the influence of methadone on postoperative analgesia after lumbar interbody fusion in opioid naïve patients or patients who are taking less than equivalent of 15 mg IV morphine each day? What is the incidence of opioid related postoperative side effects after the administration of methadone in the operating room?

Read the detailed description

Hypothesis:

  1. We hypothesize that 0.2 mg/kg of methadone will result in decreased postoperative hydromorphone consumption compared to hydromorphone alone in opioid naïve patients or patients who are taking less than the equivalent of 15 mg IV morphine a day undergoing lumbar interbody fusion.
  2. We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
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Conditions studied

  • Postoperative Pain

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Keywords

  • hydromorphone
  • lumbar posterior spinal fusion
  • lumbosacral spondylosis
  • Spinal Fusion
03

In context

Pain, Postoperative

5,095 studies on the registry are indexed under Pain, Postoperative; 1,140 are open to participants now.

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Lead sponsor

Northwestern University is the lead sponsor of 1,398 studies on the registry; 201 are open to participants now.

Of its 102 completed or terminated interventional studies of FDA-regulated products, 73 (72%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • ASA physical status I, II, and III, male and non-pregnant female
  • English-speaking patients
  • Ages 18-75 years
  • Undergoing elective one or two level posterior lumbar interbody fusion

Exclusion criteria

Exclusion Criteria:

  • Use of more than the equivalent of 15 mg of IV morphine/24 hr in the past 2 weeks.
  • Use of drugs within the past 6 months that effect the pharmacokinetics or pharmacodynamics of opioids (i.e., benzodiazepines, anti-retroviral agents, rifampin, ketoconazole, erythromycin, or phenytoin).
  • history of substance abuse at any time in the past
  • known QT prolongation
  • Non-elective operations (i.e., cancer or trauma)
  • severe hepatic impairment (serum albumin \< 3.0 g/dL in the presence of a history of liver disease)
  • pregnancy
  • inability to operate a patient-controlled analgesia device
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Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
0 participants (actual)

Study arms

  • Active comparator
    Methadone Group

    0.2 mg/kg IV methadone

    Drug: Methadone

  • Placebo comparator
    Placebo Group

    5 mL saline bolus

    Drug: Saline

Interventions

  • DrugMethadone

    0.2 mg/kg methadone IV bolus

    Also known as: Dolophine

  • DrugSaline

    3 mL saline IV bolus

    Also known as: 0.9 NaCl

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What researchers measure

Primary outcomes

  1. Hydromorphone postoperative opioid consumption (POC) at 48 hours

    PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU

    Time frame: 48 hrs

Secondary outcomes

  1. Intraoperative remifentanil consumption

    intraoperative consumption of remifentanil--the amount of remifentanil used in the OR (i.e., the 2-8 hours prior to arrival in the recovery room)

    Time frame: the 8 hours prior to arrival in the recovery room

  2. pain at rest and with movement (numerical Rating Scale, NRS)

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  3. the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  4. the number of occurrences of ventilatory depression during each evaluation interval

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  5. number of occurrences of nausea (resulting in treatment)

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  6. recorded emesis

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  7. occurrence of pruritus

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs

  8. Hydromorphone postoperative opioid consumption (POC)

    PCA opioid consumption at postoperative 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs after arriving in the PACU

    Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs

07

Study locations

1 site
  • Northwestern Memorial Hospital
    Chicago, Illinois 60611, United States
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References and documents

Publications

  • Jadad AR, Browman GP. The WHO analgesic ladder for cancer pain management. Stepping up the quality of its evaluation. JAMA. 1995 Dec 20;274(23):1870-3. PubMed 7500538 ↗
  • Upton RN, Semple TJ, Macintyre PE. Pharmacokinetic optimisation of opioid treatment in acute pain therapy. Clin Pharmacokinet. 1997 Sep;33(3):225-44. doi: 10.2165/00003088-199733030-00005. PubMed 9314613 ↗
  • Taylor S, Kirton OC, Staff I, Kozol RA. Postoperative day one: a high risk period for respiratory events. Am J Surg. 2005 Nov;190(5):752-6. doi: 10.1016/j.amjsurg.2005.07.015. PubMed 16226953 ↗
  • Taylor S, Voytovich AE, Kozol RA. Has the pendulum swung too far in postoperative pain control? Am J Surg. 2003 Nov;186(5):472-5. doi: 10.1016/j.amjsurg.2003.07.021. PubMed 14599609 ↗
  • Liu N, Kuhlman G, Dalibon N, Moutafis M, Levron JC, Fischler M. A randomized, double-blinded comparison of intrathecal morphine, sufentanil and their combination versus IV morphine patient-controlled analgesia for postthoracotomy pain. Anesth Analg. 2001 Jan;92(1):31-6. doi: 10.1097/00000539-200101000-00007. PubMed 11133596 ↗
  • Joris J, Kaba A, Lamy M. Transition between anesthesia and post-operative analgesia: relevance of intra-operative administration of analgesics. Acta Anaesthesiol Belg. 2001;52(3):271-9. PubMed 11732383 ↗
  • Carroll IR, Angst MS, Clark JD. Management of perioperative pain in patients chronically consuming opioids. Reg Anesth Pain Med. 2004 Nov-Dec;29(6):576-91. doi: 10.1016/j.rapm.2004.06.009. PubMed 15635517 ↗
  • Yaksh TL, Hua XY, Kalcheva I, Nozaki-Taguchi N, Marsala M. The spinal biology in humans and animals of pain states generated by persistent small afferent input. Proc Natl Acad Sci U S A. 1999 Jul 6;96(14):7680-6. doi: 10.1073/pnas.96.14.7680. PubMed 10393880 ↗
  • Parker RK, Holtmann B, White PF. Effects of a nighttime opioid infusion with PCA therapy on patient comfort and analgesic requirements after abdominal hysterectomy. Anesthesiology. 1992 Mar;76(3):362-7. doi: 10.1097/00000542-199203000-00007. PubMed 1539846 ↗
  • Gourlay GK, Wilson PR, Glynn CJ. Pharmacodynamics and pharmacokinetics of methadone during the perioperative period. Anesthesiology. 1982 Dec;57(6):458-67. doi: 10.1097/00000542-198212000-00005. No abstract available. PubMed 6128949 ↗
  • 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 ↗
  • Egan TD, Huizinga B, Gupta SK, Jaarsma RL, Sperry RJ, Yee JB, Muir KT. Remifentanil pharmacokinetics in obese versus lean patients. Anesthesiology. 1998 Sep;89(3):562-73. doi: 10.1097/00000542-199809000-00004. PubMed 9743391 ↗
  • Lemmens HJ, Brodsky JB, Bernstein DP. Estimating ideal body weight--a new formula. Obes Surg. 2005 Aug;15(7):1082-3. doi: 10.1381/0960892054621350. PubMed 16105412 ↗
  • Bowdle TA, Even A, Shen DD, Swardstrom M. Methadone for the induction of anesthesia: plasma histamine concentration, arterial blood pressure, and heart rate. Anesth Analg. 2004 Jun;98(6):1692-1697. doi: 10.1213/01.ANE.0000114085.20751.20. PubMed 15155330 ↗
  • Chernik DA, Gillings D, Laine H, Hendler J, Silver JM, Davidson AB, Schwam EM, Siegel JL. Validity and reliability of the Observer's Assessment of Alertness/Sedation Scale: study with intravenous midazolam. J Clin Psychopharmacol. 1990 Aug;10(4):244-51. PubMed 2286697 ↗
  • Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38. PubMed 15333398 ↗
  • van Dorp EL, Kest B, Kowalczyk WJ, Morariu AM, Waxman AR, Arout CA, Dahan A, Sarton EY. Morphine-6beta-glucuronide rapidly increases pain sensitivity independently of opioid receptor activity in mice and humans. Anesthesiology. 2009 Jun;110(6):1356-63. doi: 10.1097/ALN.0b013e3181a105de. PubMed 19461298 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 22, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01125059
Lead sponsor
Northwestern University
Collaborators
Northwestern University Feinberg School of Medicine
Responsible party
Dhanesh Gupta (Associate Professor of Anesthesiology & Neurological Surgery, Northwestern University) — Principal investigator
First posted
May 18, 2010
Start date
May 2010
Primary completion
Jan 2014
Completion
Jan 2014
Last update
Apr 22, 2015

Study contacts

Dhanesh K Gupta, M.D.
principal investigator · Northwestern University Feinberg School of Medicine

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

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