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

NCT07096635 | Not Yet Recruiting

• 1 other identifier: SM72025
• Study Type: interventional
• Target: 50
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction

Outcome Measures

Primary Outcomes (1)

• Time to first analgesic requirement

  Assessed in minutes

  24 hours after surgery

Secondary Outcomes (1)

• Postoperative pain intensity

  24 hours after surgery

Study Arms (2)

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.

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.

Other: Starch tablets

Interventions

Melatonin DRUG

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 M

Starch tablets OTHER

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.

Group C

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Assiut University: lead

MeSH Terms

Interventions

Melatonin; Starch

Intervention Hierarchy (Ancestors)

Tryptamines; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Glucans; Biopolymers; Polymers; Macromolecular Substances; Dietary Carbohydrates; Carbohydrates; Polysaccharides

Study Officials

• Seham M Moeen, M.D.

  Assiut University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Seham M Moeen, M.D.

CONTACT

01006386324; seham.moeen@aun.edu.eg

Abdallah z Fekry

CONTACT

0101206925

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assiut University

Study Record Dates

• First Submitted: July 24, 2025
• First Posted: July 31, 2025
• Study Start: October 1, 2025
• Primary Completion (Estimated): October 1, 2027
• Study Completion (Estimated): October 1, 2027
• Last Updated: July 31, 2025

Record last verified: 2025-07