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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.
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to first analgesic requirement | Assessed in minutes | 24 hours after surgery |
| Measure | Description | Time Frame |
|---|---|---|
| Postoperative pain intensity | Assessed by the visual analogue scale, an 11-point scale graded from 0 to 10 (0 = no pain, 10 = the worst imaginable pain) | 24 hours after surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Seham M Moeen, M.D. | Contact | 01006386324 | 02 | seham.moeen@aun.edu.eg |
| Abdallah z Fekry | Contact | 0101206925 | 02 |
| Name | Affiliation | Role |
|---|---|---|
| Seham M Moeen, M.D. | Assiut University | Principal Investigator |
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| ID | Term |
|---|---|
| D008550 | Melatonin |
| D013213 | Starch |
| ID | Term |
|---|---|
| D014363 | Tryptamines |
| D007211 | Indoles |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
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| 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. |
|
| D006571 | Heterocyclic Compounds |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D005936 | Glucans |
| D001704 | Biopolymers |
| D011108 | Polymers |
| D046911 | Macromolecular Substances |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011134 | Polysaccharides |