Post-operative PainNCT02300077
Methadone in Ambulatory Surgery
A study testing methadone in people with Post-operative Pain and Anesthesia, run by Washington University School of Medicine at 1 site in United States.
Trial summary
The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Post-operative Pain, Anesthesia
- What is being tested?
- methadone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2014to 12 Feb 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Age 18-65 years
- Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
- Signed, written, informed consent
Who cannot join
- History of or known liver or kidney disease.
- Females who are pregnant or nursing.
- Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
- History of allergy to methadone
Trial locations and contacts
1 site in 1 country.
About this study
The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.
- Conditions
- Post-operative Pain, Anesthesia
- Being tested
- methadone, Control (Intra-operative administration of opioids, other than methadone)
- Keywords
- fentanyl, morphine, methadone
- 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
Escalating dose of methadone up to .3mg/kg.
Control (Intra-operative administration of opioids, other than methadone)Drug
Also called morphine fentanyl
Intra-operative administration of opioids, other than methadone
| Study group | Role | What they receive |
|---|---|---|
| Control | Active comparator | Control (Intra-operative administration of opioids, other than methadone) Receives: Drug: Control (Intra-operative administration of opioids, other than methadone) |
| Treatment methadone 0.1 mg/kg | Active comparator | methadone 0.1 mg/kg Receives: Drug: methadone |
| Treatment methadone 0.15 mg/kg | Active comparator | Not described Receives: Drug: methadone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intraoperative Opioid Administration
Data on opioids administered intraoperatively will be collected from the subject's EMR.
Measured: Administered at induction of anesthesia
Postoperative Opioid Administration
Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief]
Measured: EMR reviewed at 24 hours post-administration or at hospital discharge
Secondary outcomes (2)
Opioid Consumption Within First 30 Postoperative Days
Daily opioid consumption for approx 30 days following surgery (from hospital discharge until postop clinic visit).
Measured: 30 days
Pain Relief Within First 30 Postoperative Days
Daily pain self-assessments using a numeric (0-10) rating scale were recorded in a home diary for approx 30 days following surgery (from hospital discharge until postop clinic visit). Zero was no pain and 10 was the worst possible pain.
Patient's 30-day post-discharge scores were averaged individually and compared in between groups.
In addition, participants recorded pain interference with 7 activities of daily living - mood, ability to walk or move, sleep, normal work outside the home, normal work at home, recreational activities, and enjoyment of life on a 5-point Likert scale. Questions were based on the Patient-Reported Outcomes Measurement Information System Pain Behavior and Pain Interference item banks. Patients also recorded opioid and nonopioid analgesic use, sedation, and time to return to work.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2014 (estimated)
- Study startDec 2014
- Primary completion12 Feb 2018
- Study completion12 Feb 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Washington University School of MedicineThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Washington University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Helga Komen, MD, Principal investigator, Washington University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02300077
- Sponsor's protocol ID
- 201408002
- Status last verified
- May 2019
- First submitted
- 18 Nov 2014
- Last updated
- 17 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
PubMed 29847382
Study at a glance
From the registry record, last updated by the sponsor on 17 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Methadone in Ambulatory Surgery
- ClinicalTrials.gov ID
- NCT02300077
- Acronym / sponsor ID
- 201408002
- Conditions
- Post-operative Pain, Anesthesia
- Keywords
- fentanyl, morphine, methadone
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Washington University School of MedicineUniversity, hospital or other
- Study start
- Dec 2014 (actual)
- Primary completion
- 12 Feb 2018 (actual)
- Study completion
- 12 Feb 2018 (actual)
- First posted
- 24 Nov 2014 (estimated)
- Results
- Posted 17 May 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The μ-opioid receptor agonist methadone is frequently used in adult anesthesia and adult pain therapy. Methadone has an extremely long half-life, which confers therapeutic advantage by providing more stable plasma concentrations and long-lasting pain relief. Methadone perioperative pharmacokinetics and effectiveness in perioperative pain relief in inpatients is well characterized. There is, however, no information on methadone use in an ambulatory surgery setting and outpatient procedures. This pilot investigation will determine effectiveness of intraoperative methadone in reducing postoperative opioid consumption and providing improved pain relief in patients undergoing moderately painful, ambulatory surgical procedures.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Control | Active comparator | Drug: Control (Intra-operative administration of opioids, other than methadone)Control (Intra-operative administration of opioids, other than methadone) |
| Treatment methadone 0.1 mg/kg | Active comparator | Drug: methadonemethadone 0.1 mg/kg |
| Treatment methadone 0.15 mg/kg | Active comparator | Drug: methadone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age 18-65 years
- Undergoing general anesthesia and moderately painful, ambulatory surgical procedures with anticipated overnight, postop hospital stay of < 24 hours
- Signed, written, informed consent
Key exclusion criteria (4 listed)
- History of or known liver or kidney disease.
- Females who are pregnant or nursing.
- Opioid tolerant patients (e.g. preoperative methadone therapy or use of fentanyl transdermal patches)
- History of allergy to methadone
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: DolophineEscalating dose of methadone up to .3mg/kg. | Drug | Treatment methadone 0.1 mg/kg, Treatment methadone 0.15 mg/kg |
| Control (Intra-operative administration of opioids, other than methadone)Also: morphine fentanylIntra-operative administration of opioids, other than methadone | Drug | Control |
Primary outcome
Intraoperative Opioid Administration
Time frame: Administered at induction of anesthesia
Data on opioids administered intraoperatively will be collected from the subject's EMR.
Postoperative Opioid Administration
Time frame: EMR reviewed at 24 hours post-administration or at hospital discharge
Data on opioids administered postoperatively will be collected from the subject's EMR. Pain severity will be assessed using Numeric Rating Scale and colored-visual analogue scale. Pain relief postoperatively will be assessed using a 5 point scale [0-no relief, 4-complete relief]
2 secondary outcomes
Opioid Consumption Within First 30 Postoperative Days
Time frame: 30 days
Pain Relief Within First 30 Postoperative Days
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 29847382Komen H, Brunt LM, Deych E, Blood J, Kharasch ED. Intraoperative Methadone in Same-Day Ambulatory Surgery: A Randomized, Double-Blinded, Dose-Finding Pilot Study. Anesth Analg. 2019 Apr;128(4):802-810. doi: 10.1213/ANE.0000000000003464.
- Individual participant dataSharing planned: No
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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.
Helga Komen, MD principal investigator
Washington University School of Medicine
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 in people with Post-operative Pain and Anesthesia, run by Washington University School of Medicine 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 3 inclusion and 4 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 17 May 2019. 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. 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?
Yes. Results are posted in the registry (first posted 17 May 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Intraoperative Opioid Administration (time frame: Administered at induction of anesthesia). The study lists 2 primary outcomes in all. 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 NCT02300077, which also lists 1 linked publication.
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 17 May 2019.