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

Not Applicable

Not yet recruiting

• Conditions: Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction
• Interventions: Drug: Melatonin; Other: Starch tablets

• Registration Number: NCT07096635
• Lead Sponsor: Assiut University

Brief 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.

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 Timeline

• Status Verified: 2025-07
• Study First Submitted: 2025-07-24
• Study First Submitted QC: 2025-07-24
• Last Update Submitted: 2025-07-24
• Study First Posted: 2025-07-31
• Last Update Posted: 2025-07-31
• Study Start: 2025-10-01
• Primary Completion: 2027-10-01
• Study Completion: 2027-10-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group M	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.
Group C	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

Name	Time	Method
Time to first analgesic requirement	24 hours after surgery	Assessed in minutes

Secondary Outcome Measures

Name	Time	Method
Postoperative pain intensity	24 hours after surgery	Assessed by the visual analogue scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain)