Evaluation of Dexketoprofen in Total Knee Arthroplasty

KAT General Hospital

Status and phase: Unknown; Phase 2

Conditions: Postoperative Pain; Analgesia

Treatments: Drug: Dexketoprofen Trometamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Study type: Interventional

Funder types: Other

Identifiers

NCT04161690

13022

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. Dexketoprofen is a new NSAID treating acute postoperative pain. The purpose of this study is to evaluate the analgesic effect when it is given intravenously or as part of the local infiltration analgesia in patients under spinal anesthesia undergoing unilateral total knee arthroplasty.

Enrollment: 120 estimated patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• unilateral total knee arthroplasty
• accept to enter the study
• ASA score I or II
• hospitalization for at least 2 days

Exclusion criteria

• allergy in any given medications
• active gastrointestinal bleeding or other active bleeding
• history of peptic ulcer
• renal failure
• hepatic failure
• chronic heart failure

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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120 participants in 3 patient groups, including a placebo group

Group IV

Active Comparator group

Description:

Dexketoprofen 50mg is given intravenous 10 min before the start of the surgery. Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.

Treatment:

Drug: Dexketoprofen Trometamol

Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Group Periarticular

Active Comparator group

Description:

Dexketoprofen 50mg is given as part of the local infiltration analgesia with 300mg ropivacaine. Local infiltration analgesia is proceeded by the orthopedic surgeon.

Treatment:

Drug: Dexketoprofen Trometamol

Drug: Ropivacaine Hydrochloride 7.5 MG/ML

Group P

Placebo Comparator group

Description:

Local infiltration analgesia is proceeded by the surgeon with 300mg ropivacaine.

Treatment:

Drug: Ropivacaine Hydrochloride 7.5 MG/ML