NCT07096635

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

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

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Assiut University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Conditions

• Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2025-10-01
• Primary completion: 2027-10-01
• Completion: 2027-10-01
• First posted: 2025-07-31
• Last updated: 2025-07-31