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

KAT General Hospital

Status and phase: Completed; Phase 2

Conditions: Postoperative Pain; Pain, Acute

Treatments: Drug: Dexketoprofen/tramadol (27mg/75mg); Drug: Paracetamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Tramadol hydrochloride; Drug: Levobupivacaine Hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT04178109

17200

Details and patient eligibility

About

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).

Enrollment: 226 patients

Sex: All

Ages: 45 to 80 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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226 participants in 2 patient groups, including a placebo group

Group A

Active Comparator group

Description:

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.

Treatment:

Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Drug: Levobupivacaine Hydrochloride

Drug: Dexketoprofen/tramadol (27mg/75mg)

Group B

Placebo Comparator group

Description:

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

Treatment:

Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Drug: Levobupivacaine Hydrochloride

Drug: Tramadol hydrochloride

Drug: Paracetamol