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The purpose of the study is to use duloxetine as premedication in Anterior cruciate ligament repair under spinal anesthesia and evaluate the effect on onset and duration of spinal anesthesia and postoperative pain control.
We designed this randomized, double-blind study to evaluate the effectiveness of administration of oral duloxetine 2 hours preoperatively on the onset and the duration of the spinal anesthesia in arthroscopic anterior cruciate ligament (ACL) repair and the role of duloxetine on postoperative analgesia.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group D (duloxetine group) | Active Comparator | Two hours before surgery, participants received oral duloxetine 60 mg tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. |
|
| Group C (control group) | Placebo Comparator | Two hours before surgery, participants received oral placebo tablets in the ward then transferred to OR to receive spinal anesthesia before surgery. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Duloxetine 60mg | Drug | Duloxetine is a selective SNRI prescribed in depression, anxiety, and chronic pain like diabetic neuropathy and fibromyalgia, it acts through central and peripheral pain modulation |
| Measure | Description | Time Frame |
|---|---|---|
| Assess the onset of spinal anesthesia | Time to T10 sensory block and time to Bromage 1 motor block | 20 min |
| Measure | Description | Time Frame |
|---|---|---|
| Duration of spinal anesthesia | Two-dermatomes regression for sensory recovery and return to Bromage 2 for motor recovery | 4 hours |
| Postoperative pain | Will be assessed by the patient using the visual analog scale (VAS, 0=no pain; 10=worst possible pain) every 4hrs up to 24hrs after the operation. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| tamer abdelaziz, MD | Faculty of medicine, Ain Shams University, Cairo, Egypt | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| faculty of medicine, Ain Shams University | Cairo | 11591 | Egypt |
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| ID | Term |
|---|---|
| D000068736 | Duloxetine Hydrochloride |
| ID | Term |
|---|---|
| D013876 | Thiophenes |
| D013457 | Sulfur Compounds |
| D009930 | Organic Chemicals |
| D006573 | Heterocyclic Compounds, 1-Ring |
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| Placebo | Drug | placebo tablets identical to duloxetine tablets |
|
| 24 hours |
| Time for first postoperative rescue analgesia request, frequency, and total morphine consumption | All participants will receive intravenous paracetamol, one gram every 8hrs, VAS score of 4 or more will receive 3 mg morphine intravenously and not be repeated more frequently than 4hrs limited to 12 mg morphine per 24hrs after operation | 24 hours |
| D006571 |
| Heterocyclic Compounds |