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

NCT04178109 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 226

Last updated 2019-11-26

No results posted yet for this study

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

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

Sponsors & Collaborators

  • KAT General Hospital

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
45 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-01-10
Primary Completion
2019-11-10
Completion
2019-11-20

Countries

  • Greece

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04178109 on ClinicalTrials.gov