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Pain is a global public health issue and represents the most common reason for both physician consultation and hospital admissions . When unrelieved or poorly controlled, it is associated with medical complications, poor patient satisfaction and increased risk of developing chronic pain. Dexketoprofen is a new NSAID treating acute postoperative pain and when it combined with tramadol may have a better effect. The purpose of this study is to evaluate the analgesic effect of the oral use of the combination of dexketoprofen/tramadole on the reduction of postoperative pain after total hip arthroplasty with minimal invasive anterior approach (AMIS).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Active Comparator | Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h. |
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| Group B | Placebo Comparator | Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dexketoprofen/tramadol (27mg/75mg) | Drug | Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h |
| Measure | Description | Time Frame |
|---|---|---|
| Pain score in 8hours | Pain score with the visualised analogue scale in 8hours | 8 hours |
| Pain score in 24hours | Pain score with the visualised analogue scale in 24 hours | 24 hours |
| Pain score in 48 hours | Pain score with the visualised analogue scale in 48 hours | 48 hours |
| Pain score in 72 hours | Pain score with the visualised analogue scale in 72 hours | 72 hours |
| Total analgesic consumption | Total analgesic consumption as rescue analgesia the first 24 hours | 24 houra |
| Measure | Description | Time Frame |
|---|---|---|
| Side effects | All the side effects of the drug the first 72 hours | 72 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Elena Nikolakopoulou | Athens | Kifissia | 14571 | Greece |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38204364 | Derived | Macheras GA, Tzefronis D, Argyrou C, Nikolakopoulou E, Galvez Miravete A, Karachalios TS. Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol. Hip Int. 2024 May;34(3):304-310. doi: 10.1177/11207000231219797. Epub 2024 Jan 10. |
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| Tramadol hydrochloride | Drug | Patients in group B received IV tramadol 75mg every 8h |
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| Paracetamol | Drug | Patients in group B received IV paracetamol 1g every 8h |
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| Ropivacaine Hydrochloride 7.5 MG/ML | Drug | 300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients |
|
| Levobupivacaine Hydrochloride | Drug | 10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia |
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| ID | Term |
|---|---|
| D010149 | Pain, Postoperative |
| D059787 | Acute Pain |
| ID | Term |
|---|---|
| D011183 | Postoperative Complications |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
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| ID | Term |
|---|---|
| C118296 | dexketoprofen trometamol |
| D014147 | Tramadol |
| D000082 | Acetaminophen |
| D000077212 | Ropivacaine |
| D000077554 | Levobupivacaine |
| ID | Term |
|---|---|
| D003511 | Cyclohexanols |
| D000441 | Hexanols |
| D005233 | Fatty Alcohols |
| D000438 | Alcohols |
| D009930 | Organic Chemicals |
| D004123 | Dimethylamines |
| D008744 | Methylamines |
| D000588 | Amines |
| D008055 | Lipids |
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D000814 | Aniline Compounds |
| D002045 | Bupivacaine |
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