Pain Relief After Arthroscopic Anterior Cruciate Ligament ReconstructionACLRNCT07096635
Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction
A study testing Melatonin and Starch tablets in people with Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Assiut University.
Trial summary
Anterior Cruciate Ligament Reconstruction (ACLR) is a common orthopedic procedure that is accompanied by moderate to severe postoperative pain and is primarily performed on an outpatient basis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction
- What is being tested?
- Melatonin and Starch tablets
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- No sites listed yet
- Study dates
- 1 Oct 2025to 1 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 unilateral arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old, and who are American Society of Anesthesiologists (ASA) physical status I or II of either sex
Who cannot join
- Contraindications to neuraxial anesthesia (e.g. allergy to local anesthetics, coagulopathies, infection in the area)
- History of cardiovascular, cerebrovascular, respiratory, or psychological disorders
- Chronic pain syndrome and/ or opioid use
- Regular consumption of analgesics, corticosteroids or anticonvulsants
- A known allergy to melatonin
- Patients with diabetes mellitus, sever hypertension, liver or renal dysfunction
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- Cognitive disorders (dementia, major depression)
- Circadian rhythm disorders (such as chronic fatigue syndrome and drowsiness)
- Pregnancy/ lactating
- Body mass index 35 kg/m2 or more,
- Patient refusal.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
Abdallah z Fekry contact
About this study
Official title: Effect of Preoperative Oral Melatonin With Intra Articular Analgesia on Post-Operative Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction Under Spinal Anesthesia. A Randomized Comparative Controlled Clinical Trial
Anterior Cruciate Ligament Reconstruction (ACLR) is a common orthopedic procedure that is accompanied by moderate to severe postoperative pain and is primarily performed on an outpatient basis.
Read the detailed description
Many different pain control treatments are used in the management of patients after ACLR, including various permutations of nerve blocks, nerve block adjuncts (NBAs), intra-articular injections, intravenous (IV), oral medications, and cryotherapy, as well as compression stockings. Despite this, no gold-standard postoperative analgesia guideline has emerged.
Melatonin (N-acetyl-5-methoxytryptamine) is a naturally-occurring hormone in the human body and offers antiemetic, analgesic, and anxiolytic effects
- Being tested
- Melatonin, Starch tablets
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MelatoninDrug
Patients will receive oral melatonin 10 mg (two 5 mg tablets) one hour before the operation plus intra-articular analgesia at the end of surgery.
Starch tabletsOther
Patients will receive two oral inert starch tablets of the same shape and color one hour before the operation plus intra-articular analgesia at the end of surgery.
| Study group | Role | What they receive |
|---|---|---|
| Group M | Active comparator | Patients will receive oral melatonin 10 mg (two 5 mg tablets) one hour before the operation plus intra-articular analgesia at the end of surgery. Receives: Drug: Melatonin |
| Group C | Placebo comparator | Patients will receive two oral inert starch tablets of the same shape and color one hour before the operation plus intra-articular analgesia at the end of surgery. Receives: Other: Starch tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to first analgesic requirement
Assessed in minutes
Measured: 24 hours after surgery
Secondary outcomes (1)
Postoperative pain intensity
Assessed by the visual analogue scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)
Measured: 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Jul 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Oct 2027 (estimated)
- Study completion1 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain Relief After Arthroscopic Anterior Cruciate Ligament ReconstructionStudies of the same condition, open and under way.
- More trials run by Assiut 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Seham Mohamed Moeen Ibrahim, Assiut University
- Investigators
- Seham M Moeen, M.D., Principal investigator, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07096635
- Sponsor's protocol ID
- SM72025
- Acronym
- ACLR
- Status last verified
- Jul 2025
- First submitted
- 24 Jul 2025
- Last updated
- 31 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Preoperative Oral Melatonin With Intra Articular Analgesia on Post-Operative Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction Under Spinal Anesthesia. A Randomized Comparative Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07096635
- Acronym / sponsor ID
- ACLR / SM72025
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Oct 2027 (estimated)
- Study completion
- 1 Oct 2027 (estimated)
- First posted
- 31 Jul 2025 (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.
Anterior Cruciate Ligament Reconstruction (ACLR) is a common orthopedic procedure that is accompanied by moderate to severe postoperative pain and is primarily performed on an outpatient basis.
Detailed description
Many different pain control treatments are used in the management of patients after ACLR, including various permutations of nerve blocks, nerve block adjuncts (NBAs), intra-articular injections, intravenous (IV), oral medications, and cryotherapy, as well as compression stockings. Despite this, no gold-standard postoperative analgesia guideline has emerged.
Melatonin (N-acetyl-5-methoxytryptamine) is a naturally-occurring hormone in the human body and offers antiemetic, analgesic, and anxiolytic effects
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group M | Active comparator | Drug: MelatoninPatients will receive oral melatonin 10 mg (two 5 mg tablets) one hour before the operation plus intra-articular analgesia at the end of surgery. |
| Group C | Placebo comparator | Other: Starch tabletsPatients will receive two oral inert starch tablets of the same shape and color one hour before the operation plus intra-articular analgesia at the end of surgery. |
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 unilateral arthroscopic reconstruction of the anterior cruciate ligament (ACL) under spinal anesthesia, aged from 18 to 65 years old, and who are American Society of Anesthesiologists (ASA) physical status I or II of either sex
Key exclusion criteria (11 listed)
- Contraindications to neuraxial anesthesia (e.g. allergy to local anesthetics, coagulopathies, infection in the area)
- History of cardiovascular, cerebrovascular, respiratory, or psychological disorders
- Chronic pain syndrome and/ or opioid use
- Regular consumption of analgesics, corticosteroids or anticonvulsants
- A known allergy to melatonin
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 |
|---|---|---|
| MelatoninPatients will receive oral melatonin 10 mg (two 5 mg tablets) one hour before the operation plus intra-articular analgesia at the end of surgery. | Drug | Group M |
| Starch tabletsPatients will receive two oral inert starch tablets of the same shape and color one hour before the operation plus intra-articular analgesia at the end of surgery. | Other | Group C |
Primary outcome
Time to first analgesic requirement
Time frame: 24 hours after surgery
Assessed in minutes
1 secondary outcome
Postoperative pain intensity
Time frame: 24 hours after surgery
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2025.
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.
Abdallah z Fekry contact
Seham M Moeen, M.D. principal investigator
Assiut University
Questions about this trial
What is this clinical trial studying?
A study testing Melatonin and Starch tablets in people with Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction, run by Assiut University.
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 11 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: opening soon, as of the sponsor's last update on 31 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Seham M Moeen, M.D. (01006386324 ext. 02, seham.moeen@aun.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to first analgesic requirement (time frame: 24 hours after 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 31 Jul 2025.