Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Melatonin, Starch tablets.
- Who it may be relevant to
- Registry conditions: Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction. Basic parameters: 18 years — 65 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
Interventions
- Drug Melatonin
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. - Other Starch tablets
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.
Primary outcome measures
- Time to first analgesic requirement [Time frame: 24 hours after surgery]
Secondary outcome measures (1)
- Postoperative pain intensity [Time frame: 24 hours after surgery]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- 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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Quadruple blind
- Primary purpose
- Prevention
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07096635 · SM72025