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

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07096635

Acronym

ACLR

Enrollment

Registered

2025-07-31

Start date

2025-10-01

Completion date

2027-10-01

Last updated

2025-07-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain Relief After Arthroscopic Anterior Cruciate Ligament Reconstruction

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

Interventions

DRUGMelatonin

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.

OTHERStarch 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.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

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.

Design outcomes

Primary

Measure	Time frame	Description
Time to first analgesic requirement	24 hours after surgery	Assessed in minutes

Secondary

Measure	Time frame	Description
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)

Contacts

Primary ContactSeham M Moeen, M.D.

seham.moeen@aun.edu.eg01006386324

Backup ContactAbdallah z Fekry

0101206925

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026