Pain ManagementCSNCT07380568
Melatonin on Post Operative Pain After CS
A study testing Melatonin 5 mg and Melatonin 10 mg in people with Pain Management and Pain After Surgery, run by Benha University at 1 site in Egypt.
Trial summary
The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are: Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different… Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pain Management, Pain After Surgery, Cesarean Section Pain
- What is being tested?
- Melatonin 5 mg and Melatonin 10 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 10 Oct 2025to 1 Apr 2026
- 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 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- - Women aged 18-40 years.
- Scheduled for elective cesarean section.
- Ability to provide informed consent.
Who cannot join
- Known hypersensitivity to melatonin or opioids
- Chronic use of analgesics, sedatives, or antidepressants.
- History of sleep disorders or psychiatric illness.
- Complicated pregnancies (e.g., preeclampsia, gestational diabetes).
- Body mass index (BMI) > 35 kg/m².
- Emergency cesarean sections.
- Severe systemic diseases (e.g., liver or kidney dysfunction).
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study
The goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are:
Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S.
Participants will:
Take melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia
- Conditions
- Pain Management, Pain After Surgery, Cesarean Section Pain
- Being tested
- Melatonin 5 mg, Melatonin 10 mg, Placebo
- Keywords
- melatonin and pain after C.S
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Melatonin 5 mgDrug
Group I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section.
Melatonin 10 mgDrug
Group II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section.
PlaceboDrug
Group III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section.
| Study group | Role | What they receive |
|---|---|---|
| Group I: (5 mg melatonin) | Active comparator | Not described Receives: Drug: Melatonin 5 mg |
| Group II: (10 mg melatonin) | Active comparator | Not described Receives: Drug: Melatonin 10 mg |
| Group III: (Placebo) | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable
Measured: 2, 6, 12, and 24 hours post-surgery.
Secondary outcomes (4)
first rescue analgesia
Time to first request for analgesia postoperatively
Measured: the first 24 hours post operative
Total opioid consumption
amount of opioid requested by the patient
Measured: the first 24 hours post operative
Incidence of adverse effects
such as nausea, vomiting, headache, dizziness, sedation
Measured: first 24 hours post operative
Time to first ambulation post-surgery
first movement by the patient
Measured: first 24 hours post operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2026
- Study start10 Oct 2025
- Primary completion1 Mar 2026
- Study completion1 Apr 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Benha University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Taghreed Elshahat Sakr, Benha University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07380568
- Sponsor's protocol ID
- RC.3.9.2025
- Acronym
- CS
- Status last verified
- Jul 2026
- First submitted
- 28 Dec 2025
- Last updated
- 14 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Preoperative Oral Melatonin on Postoperative Pain Control After Cesarean Section: A Dose Comparison Study
- ClinicalTrials.gov ID
- NCT07380568
- Acronym / sponsor ID
- CS / RC.3.9.2025
- Conditions
- Pain Management, Pain After Surgery, Cesarean Section Pain
- Keywords
- melatonin and pain after C.S
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Benha UniversityUniversity, hospital or other
- Study start
- 10 Oct 2025 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Apr 2026 (actual)
- First posted
- 2 Feb 2026 (actual)
- 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 goal of this clinical trial is to learn if melatonin will decrease pain after C.S. The main questions it aims to answer are:
Does melatonin lower the number of times participants need to use a rescue analgesia? What medical problems do participants have when taking melatonin? Researchers will compare different doses of melatonin to see the ideal dose to decrease pain after C.S.
Participants will:
Take melatonin 30 min before C.S and will be observed for 24 hours for pain and consumption of other analgesia
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Group I: (5 mg melatonin) | Active comparator | Drug: Melatonin 5 mg |
| Group II: (10 mg melatonin) | Active comparator | Drug: Melatonin 10 mg |
| Group III: (Placebo) | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- - Women aged 18-40 years.
- Scheduled for elective cesarean section.
- Ability to provide informed consent.
Key exclusion criteria (7 listed)
- Known hypersensitivity to melatonin or opioids
- Chronic use of analgesics, sedatives, or antidepressants.
- History of sleep disorders or psychiatric illness.
- Complicated pregnancies (e.g., preeclampsia, gestational diabetes).
- Body mass index (BMI) > 35 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 |
|---|---|---|
| Melatonin 5 mgGroup I: (5 mg melatonin): Participants will receive 5 mg of oral melatonin 1 hours before the cesarean section. | Drug | Group I: (5 mg melatonin) |
| Melatonin 10 mgGroup II: (10 mg melatonin): Participants will receive 10 mg of oral melatonin 1 hours before the cesarean section. | Drug | Group II: (10 mg melatonin) |
| PlaceboGroup III: (Placebo): Participants will receive an identical placebo tablet 1 hours before the cesarean section. | Drug | Group III: (Placebo) |
Primary outcome
Postoperative pain intensity measured using the VAS (Visual Analogue Scale)
Time frame: 2, 6, 12, and 24 hours post-surgery.
it typically consists of a 100 mm straight line with descriptive anchors at each end representing the extremes of the sensation (for example, "no pain" at one end and "the most severe pain imaginable" at the other). Respondents indicate their experience by marking a point on the line, and the distance from the lower anchor is measured and recorded as a continuous variable
4 secondary outcomes
first rescue analgesia
Time frame: the first 24 hours post operative
Total opioid consumption
Time frame: the first 24 hours post operative
Incidence of adverse effects
Time frame: first 24 hours post operative
Time to first ambulation post-surgery
Time frame: first 24 hours post operative
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 14 Jul 2026.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin 5 mg and Melatonin 10 mg in people with Pain Management and Pain After Surgery, run by Benha University at 1 site in Egypt.
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: finished, as of the sponsor's last update on 14 Jul 2026. 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 Egypt. 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 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?
Postoperative pain intensity measured using the VAS (Visual Analogue Scale) (time frame: 2, 6, 12, and 24 hours post-surgery.). 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 14 Jul 2026; AzTrials last refreshed its copy on 30 Oct 2026.