Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
NCT ID: NCT04178109
Last Updated: 2019-11-26
Study Results
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Basic Information
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COMPLETED
PHASE2
226 participants
INTERVENTIONAL
2019-01-10
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group A
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.
Dexketoprofen/tramadol (27mg/75mg)
Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
Ropivacaine Hydrochloride 7.5 MG/ML
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
10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
Group B
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
Tramadol hydrochloride
Patients in group B received IV tramadol 75mg every 8h
Paracetamol
Patients in group B received IV paracetamol 1g every 8h
Ropivacaine Hydrochloride 7.5 MG/ML
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
10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
Interventions
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Dexketoprofen/tramadol (27mg/75mg)
Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
Tramadol hydrochloride
Patients in group B received IV tramadol 75mg every 8h
Paracetamol
Patients in group B received IV paracetamol 1g every 8h
Ropivacaine Hydrochloride 7.5 MG/ML
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
10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
Eligibility Criteria
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Inclusion Criteria
* ASA score I or II
* signed written informed consent form
* 3 days hospitalization
* 45-80 years old
* primary Total hip arthroplasty
Exclusion Criteria
* contraindications for spinal anesthesia
* active bleeding
* renal failure ( gfr\< 90ml/h)
* hepatic failure ( abnormal sgot,sgpt,γgt)
* heart failure
* history of gastrointestinal bleeding
45 Years
80 Years
ALL
Yes
Sponsors
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KAT General Hospital
OTHER
Responsible Party
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Elena Nikolakopoulou
MD
Locations
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Elena Nikolakopoulou
Athens, Kifissia, Greece
Countries
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References
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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.
Other Identifiers
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17200
Identifier Type: -
Identifier Source: org_study_id
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