Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07096635

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

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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.

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.

Primary outcomes

  1. Time to first analgesic requirement

    Time frame: 24 hours after surgery

    Assessed in minutes

Secondary outcomes

  1. Postoperative pain intensity

    Time frame: 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)

Study contacts

Contact information is provided by the study sponsor or research team.

Abdallah z Fekry

CONTACT

0101206925 ext. 02

Seham M Moeen, M.D.

CONTACT

[email protected]

01006386324 ext. 02

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study 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

Acronym: ACLR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jul 31, 2025
Registry last updated
Jul 31, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.