Postoperative PainPhase 4NCT02639741
Preoperative Melatonin or Vitamin C Administration on Postoperative Analgesia
A Phase 4 study testing Melatonin and Vitamin C in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
Trial summary
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Melatonin and Vitamin C
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 55 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Nov 2014to 30 Dec 2020
- Phase
- Phase 4
- 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
- Patients undergoing elective major abdominal surgery with general anesthesia
Who cannot join
- A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery.
Read the detailed description
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.
- Conditions
- Postoperative Pain
- Keywords
- Melatonin, Vitamin C, Morphine consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Also called Melatonina 3 mg tb,
Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated
Vitamin CDrug
Also called Vitamin C 1000 mg tb
Preoperative vitamin C tablet will be given and postoperative pain scores will be evaluated
PlaceboOther
Also called Placebo tb
Preoperative placebo tablet will be given and postoperative pain scores will be evaluated
| Study group | Role | What they receive |
|---|---|---|
| Oral Melatonin Tablet | Active comparator | Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia. Receives: Drug: Melatonin; Drug: Vitamin C; Other: Placebo |
| Oral Vitamin C Tablet | Active comparator | Melatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia. Receives: Drug: Melatonin; Drug: Vitamin C; Other: Placebo |
| Oral Placebo Tablet | Placebo comparator | Preoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. Receives: Drug: Melatonin; Drug: Vitamin C; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
morphine consumption at 24 hours after surgery.)
Measured: 24 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Dec 2015 (estimated)
- Study startNov 2014
- Primary completion1 Jan 2020
- Study completion30 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- More trials run by Cukurova 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 55 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cukurova University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hakki Unlugenc, Cukurova University
- Investigators
- Hakkı Ünlügenç, Prof Dr., Study director, Cukurova University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02639741
- Sponsor's protocol ID
- HZLTNS99
- Status last verified
- Aug 2021
- First submitted
- 11 Nov 2015
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Of The Effects Of Preoperative Melatonin Or Vitamin C Administration On Postoperative Analgesia
- ClinicalTrials.gov ID
- NCT02639741
- Acronym / sponsor ID
- HZLTNS99
- Conditions
- Postoperative Pain
- Keywords
- Melatonin, Vitamin C, Morphine consumption
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 55 participants (actual)
- Lead sponsor
- Cukurova UniversityUniversity, hospital or other
- Study start
- Nov 2014
- Primary completion
- 1 Jan 2020 (actual)
- Study completion
- 30 Dec 2020 (actual)
- First posted
- 24 Dec 2015 (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.
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery.
Detailed description
The investigators designed a randomized double-blind placebo-controlled trial to evaluate the effect of preoperative single dose of oral melatonin and vitamin C administration on postoperative analgesia in patients undergoing elective major abdominal surgery. One hundred-sixty five ASA I-II adult patients between 18-65 years of age, undergoing elective major abdominal surgery with general anesthesia will be included in this double blinded, randomised, controlled study. Patients will randomly divided into equal (n=55) three groups. Preoperatively, one hour before surgery, patients will receive melatonin (6 mg) in group M, vitamin C (2 gr) in group C or placebo tablet in group P orally. A standard anesthetic protocol will be administered to all patients. At the end of surgery, postoperative pain control will be provided via a patient controlled analgesia (PCA) device including morphine in all groups. Hemodynamic parameters, pain, sedation, patient satisfaction, total morphine consumption, supplement analgesic requirement, incidence of nausea and vomiting and other side effects will be recorded at 5, 10, 30 min and 1, 2, 4, 6, 8, 12, 24 hr after surgery.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Oral Melatonin Tablet | Active comparator | Drug: Melatonin, Drug: Vitamin C, Other: PlaceboMelatonin, Vitamin C and placebo tablet Preoperative single oral dose of melatonin (6 mg) or placebo tablet will be given one hour before the start of anesthesia. |
| Oral Vitamin C Tablet | Active comparator | Drug: Melatonin, Drug: Vitamin C, Other: PlaceboMelatonin, Vitamin C and placebo tablet Preoperative single oral dose of vitamin C (2 gr) or placebo tablet will be given one hour before the start of anesthesia. |
| Oral Placebo Tablet | Placebo comparator | Drug: Melatonin, Drug: Vitamin C, Other: PlaceboPreoperative single oral dose of placebo tablet will be given one hour before the start of anesthesia. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing elective major abdominal surgery with general anesthesia
Key exclusion criteria (1 listed)
- A history of psychiatric disorders, chronic pain syndromes, obstructive sleep apnea, severe asthma, chronic obstructive pulmonary disease, congestive heart failure, hepatic or renal failure, patients with pregnancy or in lactation period or a history of allergic reaction to any drugs
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 |
|---|---|---|
| MelatoninAlso: Melatonina 3 mg tb,Preoperative melatonin tablet will be given and postoperative pain scores will be evaluated | Drug | Oral Melatonin Tablet, Oral Placebo Tablet, Oral Vitamin C Tablet |
| Vitamin CAlso: Vitamin C 1000 mg tbPreoperative vitamin C tablet will be given and postoperative pain scores will be evaluated | Drug | Oral Melatonin Tablet, Oral Placebo Tablet, Oral Vitamin C Tablet |
| PlaceboAlso: Placebo tbPreoperative placebo tablet will be given and postoperative pain scores will be evaluated | Other | Oral Melatonin Tablet, Oral Placebo Tablet, Oral Vitamin C Tablet |
Primary outcome
morphine consumption at 24 hours after surgery.)
Time frame: 24 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- 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.
Hakkı Ünlügenç, Prof Dr. study director
Cukurova University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Melatonin and Vitamin C in people with Postoperative Pain, run by Cukurova University at 1 site in Turkey (Türkiye).
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 1 inclusion and 1 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 9 Aug 2021. 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 Turkey (Türkiye). 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
morphine consumption at 24 hours after surgery.) (time frame: 24 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Aug 2021.