Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.

Study Overview
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Brief Summary
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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).

Official Title
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EVALUATION OF ORAL USE OF DEXKETOPROFEN/TRAMADOL IN ACUTE POSTOPERATIVE PAIN IN PATIENTS UNDERGOING TOTAL HIP REPLACEMENT WITH A MINIMALLY INVASIVE ANTERIOR APPROACH (AMIS).

Conditions
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Postoperative Pain, Pain, Acute

Intervention / Treatment
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* Drug: Dexketoprofen/tramadol (27mg/75mg)
* Drug: Tramadol hydrochloride
* Drug: Paracetamol
* Drug: Ropivacaine Hydrochloride 7.5 MG/ML
* Drug: Levobupivacaine Hydrochloride


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: unilateral total hip arthroplasty with a direct anterior minimal invasive technique ASA score I or II signed written informed consent form 3 days hospitalization 45-80 years old primary Total hip arthroplasty Exclusion Criteria: allergy to any given drugs contraindications for spinal anesthesia active bleeding renal failure ( gfr< 90ml/h) hepatic failure ( abnormal sgot,sgpt,γgt) heart failure history of gastrointestinal bleeding

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Group A<br>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. | Drug: Dexketoprofen/tramadol (27mg/75mg)<br>* Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h<br>Drug: Ropivacaine Hydrochloride 7.5 MG/ML<br>* 300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients<br>Drug: Levobupivacaine Hydrochloride<br>* 10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia<br>|
| Placebo Comparator: Group B<br>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 | Drug: Tramadol hydrochloride<br>* Patients in group B received IV tramadol 75mg every 8h<br>Drug: Paracetamol<br>* Patients in group B received IV paracetamol 1g every 8h<br>Drug: Ropivacaine Hydrochloride 7.5 MG/ML<br>* 300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients<br>Drug: Levobupivacaine Hydrochloride<br>* 10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Side effects | All the side effects of the drug the first 72 hours | 72 hours |