NCT04178109

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

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 226 (actual)
• Sponsor: KAT General Hospital · Academic / Other
• Sex: All
• Age: 45 Years – 80 Years
• Healthy volunteers: Accepted

Summary

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).

Conditions

• Postoperative Pain
• Pain, Acute

Interventions

Type	Name	Description
DRUG	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
DRUG	Tramadol hydrochloride	Patients in group B received IV tramadol 75mg every 8h
DRUG	Paracetamol	Patients in group B received IV paracetamol 1g every 8h
DRUG	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
DRUG	Levobupivacaine Hydrochloride	10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia

Timeline

• Start date: 2019-01-10
• Primary completion: 2019-11-10
• Completion: 2019-11-20
• First posted: 2019-11-26
• Last updated: 2019-11-26

Locations

1 site across 1 country: Greece