Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.NCT01126294
Perioperative Melatonin in Lumbar Laminectomy
A study testing 5 mg melatonin and 10 mg melatonin in people with Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy., run by University Health Network, Toronto at 1 site in Canada.
Trial summary
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.
- What is being tested?
- 5 mg melatonin and 10 mg melatonin
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 84 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Sep 2011
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age 18 to 65 years old
- ASA status 1-3
- having lumbar laminectomy 2 to 3 levels with or without fusion
Who cannot join
- receiving emergent procedure
- surgery for neoplastic spine lesion
- allergy to melatonin or its non-medicinal ingredients
- allergy or contraindication
- BMI over 35 or or less than 20 kg/m2
- pregnancy or breastfeeding
- failure to provide informed consent
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Toronto Western Hospital
Toronto, Ontario, M5T 2S8
Uma Victor, MBBS, 416 603-5800 ext. 6137, uma.victor@uhn.on.ca
Philip Peng, MD
About this study
Official title: Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.
- Being tested
- 5 mg melatonin, 10 mg melatonin, Placebo
- Keywords
- lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
- Medical subject headings
- Pain, Anxiety Disorders, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
5 mg melatoninDietary supplement
Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
10 mg melatoninDietary supplement
Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery.
PlaceboDietary supplement
Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery.
| Study group | Role | What they receive |
|---|---|---|
| Melatonin 5 mg | Experimental | Patients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. Receives: Dietary Supplement: 5 mg melatonin |
| Melatonin 10 mg | Experimental | Patients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. Receives: Dietary Supplement: 10 mg melatonin |
| Placebo | Placebo comparator | Patients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. Receives: Dietary Supplement: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
Measured: 24 hours
Anxiety
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 May 2010 (estimated)
- Study startApr 2010
- Primary completionJul 2011 (estimated)
- Study completionSep 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy.Studies of the same condition, open and under way.
- More trials run by University Health Network, TorontoThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 84 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Health Network, Toronto
- Sponsor type
- University, hospital or other
- Investigators
- Philip Peng, MD, Principal investigator, University Health Network, Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01126294
- Sponsor's protocol ID
- 09-0172-B
- Status last verified
- Apr 2010
- First submitted
- 17 May 2010
- Last updated
- 19 May 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.
PubMed 33319916
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Analgesic and Anxiolytic Effect of Melatonin in Patients Undergoing Lumbar Laminectomy
- ClinicalTrials.gov ID
- NCT01126294
- Acronym / sponsor ID
- 09-0172-B
- Keywords
- lumbar laminectomy, melatonin, perioperative, pain, anxiety, analgesia, VAS score
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 84 participants (estimated)
- Lead sponsor
- University Health Network, TorontoUniversity, hospital or other
- Study start
- Apr 2010
- Primary completion
- Jul 2011 (estimated)
- Study completion
- Sep 2011 (estimated)
- First posted
- 19 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.
Patients undergoing lumbar laminectomy surgery will receive either 5 or 10 mg melatonin or placebo once the evening before surgery and again 90 minutes before surgery. Pain and anxiety will be assessed over the 24 hour period following surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Melatonin 5 mg | Experimental | Dietary Supplement: 5 mg melatoninPatients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
| Melatonin 10 mg | Experimental | Dietary Supplement: 10 mg melatoninPatients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. |
| Placebo | Placebo comparator | Dietary Supplement: PlaceboPatients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. |
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 to 65 years old
- ASA status 1-3
- having lumbar laminectomy 2 to 3 levels with or without fusion
Key exclusion criteria (7 listed)
- receiving emergent procedure
- surgery for neoplastic spine lesion
- allergy to melatonin or its non-medicinal ingredients
- allergy or contraindication
- BMI over 35 or or less than 20 kg/m2
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 |
|---|---|---|
| 5 mg melatoninPatients will receive 5 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. | Dietary supplement | Melatonin 5 mg |
| 10 mg melatoninPatients will receive 10 mg melatonin once the evening before surgery and then again at 90 minutes before surgery. | Dietary supplement | Melatonin 10 mg |
| PlaceboPatients will receive placebo once the evening before surgery and then again at 90 minutes before surgery. | Dietary supplement | Placebo |
Primary outcome
Pain
Time frame: 24 hours
Pain will be assessed over a 24 hour period following surgery using a visual analogue scale
Anxiety
Time frame: 24 hours
Anxiety will be assessed over a 24 hour following surgery using visual analogue scale
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2010.
- Derived from this study: PubMed 33319916Madsen BK, Zetner D, Moller AM, Rosenberg J. Melatonin for preoperative and postoperative anxiety in adults. Cochrane Database Syst Rev. 2020 Dec 8;12(12):CD009861. doi: 10.1002/14651858.CD009861.pub3.
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.
Philip Peng, MD principal investigator
University Health Network, Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 5 mg melatonin and 10 mg melatonin in people with Pain and Anxiety in Patients Undergoing Surgery for Lumbar Laminectomy., run by University Health Network, Toronto at 1 site in Canada.
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 7 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: status not confirmed, as of the sponsor's last update on 19 May 2010. 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 Canada. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Philip Peng, MD (416 603-5118, philip.peng@uhn.on.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain (time frame: 24 hours). 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 NCT01126294, 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 19 May 2010.