Postoperative PainNCT01125059
Methadone Versus Placebo in Spine Fusion
A study testing Methadone and Saline in people with Postoperative Pain, run by Northwestern University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Methadone and Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2010to Jan 2014
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Northwestern Memorial Hospital
Chicago, Illinois, 60611
About this study
Official title: The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
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:
- 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.
- We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
- Conditions
- Postoperative Pain
- Being tested
- Methadone, Saline
- Keywords
- hydromorphone, lumbar posterior spinal fusion, lumbosacral spondylosis, Spinal Fusion
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MethadoneDrug
Also called Dolophine
0.2 mg/kg methadone IV bolus
SalineDrug
Also called 0.9 NaCl
3 mL saline IV bolus
| Study group | Role | What they receive |
|---|---|---|
| Methadone Group | Active comparator | 0.2 mg/kg IV methadone Receives: Drug: Methadone |
| Placebo Group | Placebo comparator | 5 mL saline bolus Receives: Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hydromorphone postoperative opioid consumption (POC) at 48 hours
PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU
Measured: 48 hrs
Secondary outcomes (8)
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)
Measured: the 8 hours prior to arrival in the recovery room
pain at rest and with movement (numerical Rating Scale, NRS)
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
the level of sedation (modified Observer's Assessment of Alertness and Sedation Scale, modified OAA/S scale)
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
the number of occurrences of ventilatory depression during each evaluation interval
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
number of occurrences of nausea (resulting in treatment)
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
recorded emesis
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
occurrence of pruritus
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
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
Measured: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2010 (estimated)
- Study startMay 2010
- Primary completionJan 2014
- Study completionJan 2014
Why it stopped: Unable to fulfill recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (17)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Northwestern UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northwestern University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dhanesh Gupta, Northwestern University
- Investigators
- Dhanesh K Gupta, M.D., Principal investigator, Northwestern University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01125059
- Sponsor's protocol ID
- STU00027431
- Status last verified
- Apr 2015
- First submitted
- 11 May 2010
- Last updated
- 22 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
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 7500538Upton 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 9314613Taylor 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 16226953Taylor 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 14599609Liu 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 11133596Joris 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 11732383Carroll 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 15635517Yaksh 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 10393880Parker 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 1539846Gourlay 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 6128949Chui 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 1609941Egan 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 9743391Lemmens 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 16105412Bowdle 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 15155330Chernik 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
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Methadone on Perioperative Analgesia After Posterior Lumbar Fusion - A Randomized, Placebo-controlled, Double-blinded Study
- ClinicalTrials.gov ID
- NCT01125059
- Acronym / sponsor ID
- STU00027431
- Conditions
- Postoperative Pain
- Keywords
- hydromorphone, lumbar posterior spinal fusion, lumbosacral spondylosis, Spinal Fusion
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Unable to fulfill recruitment
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Northwestern UniversityUniversity, hospital or other
- Study start
- May 2010
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 18 May 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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?
Detailed description
Hypothesis:
- 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.
- We hypothesize that the incidence of opioid related postoperative side effects will not be increased by the administration of methadone in the operating room.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Methadone Group | Active comparator | Drug: Methadone0.2 mg/kg IV methadone |
| Placebo Group | Placebo comparator | Drug: Saline5 mL saline bolus |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethadoneAlso: Dolophine0.2 mg/kg methadone IV bolus | Drug | Methadone Group |
| SalineAlso: 0.9 NaCl3 mL saline IV bolus | Drug | Placebo Group |
Primary outcome
Hydromorphone postoperative opioid consumption (POC) at 48 hours
Time frame: 48 hrs
PCA opioid consumption during the initial postoperative 48 hours after arriving in the PACU
8 secondary outcomes
Intraoperative remifentanil consumption
Time frame: the 8 hours prior to arrival in the recovery room
pain at rest and with movement (numerical Rating Scale, NRS)
Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
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
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
number of occurrences of nausea (resulting in treatment)
Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
recorded emesis
Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
occurrence of pruritus
Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs, 48 hrs
Hydromorphone postoperative opioid consumption (POC)
Time frame: 1 hr, 6 hrs, 12 hrs, 24 hrs, 36 hrs
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2015.
- Background: PubMed 7500538Jadad 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.
- Background: PubMed 9314613Upton 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.
- Background: PubMed 16226953Taylor 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.
- Background: PubMed 14599609Taylor 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.
- Background: PubMed 11133596Liu 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.
- Background: PubMed 11732383Joris 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.
- Background: PubMed 15635517Carroll 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.
- Background: PubMed 10393880Yaksh 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.
- Background: PubMed 1539846Parker 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.
- Background: PubMed 6128949Gourlay 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.
- Background: PubMed 1609941Chui 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.
- Background: PubMed 9743391Egan 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.
Related trials for Postoperative Pain
RecruitingPhase 4
ESP Blocks for Posterior Spinal Fusion
Postoperative Pain
Recruiting
Effect of Cryotherapeutic and Nanotherapeutic Sodium Hypochlorite on Post-Operative Endodontic Pain.
Symptomatic Irreversible Pulpitis, Symptomatic Apical Periodontitis
RecruitingPhase 2
REctus Sheath Trial
Acute Pain, Postoperative Pain, Acute
Not yet recruiting
Effect of Pectoral Nerve Block (PECS) Using Magnesium Sulfate Added to Dexamethasone on Quality of Recovery and Chronic Post-Mastectomy Pain
Breast Cancer, Postoperative Pain
Active, not recruitingPhase 4
Effect of Dexmedetomidine on Postoperative Pain in Spinal Anesthesia for Cesarean Section at Assuit University Hospital
Cesarean Section
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dhanesh K Gupta, M.D. principal investigator
Northwestern University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Methadone and Saline in people with Postoperative Pain, run by Northwestern University at 1 site in United States.
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 4 inclusion and 8 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: withdrawn, as of the sponsor's last update on 22 Apr 2015. 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 United States. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Hydromorphone postoperative opioid consumption (POC) at 48 hours (time frame: 48 hrs). 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 NCT01125059, which also lists 17 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 22 Apr 2015.