Oral Melatonin With Intra Articular Analgesia on Pain After Arthroscopic Anterior Cruciate Ligament Reconstruction (ACLR)

Assiut University

Status: Not yet enrolling

Conditions: Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction

Treatments: Other: Starch tablets; Drug: Melatonin

Study type: Interventional

Funder types: Other

Identifiers

NCT07096635

SM72025

Details and patient eligibility

About

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.

Full 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

Enrollment: 50 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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50 participants in 2 patient groups, including a placebo group

Group M

Active Comparator group

Description:

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.

Treatment:

Drug: Melatonin

Group C

Placebo Comparator group

Description:

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.

Treatment:

Other: Starch tablets