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

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04178109

Enrollment

226

Registered

2019-11-26

Start date

2019-01-10

Completion date

2019-11-20

Last updated

2019-11-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Pain, Acute

Brief 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).

Interventions

DRUGTramadol hydrochloride

Patients in group B received IV tramadol 75mg every 8h

DRUGParacetamol

Patients in group B received IV paracetamol 1g every 8h

DRUGRopivacaine 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

DRUGLevobupivacaine Hydrochloride

10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia

DRUGDexketoprofen/tramadol (27mg/75mg)

Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Investigator)

Eligibility

Sex/Gender

ALL

Age

45 Years to 80 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame	Description
Pain score in 8hours	8 hours	Pain score with the visualised analogue scale in 8hours
Pain score in 24hours	24 hours	Pain score with the visualised analogue scale in 24 hours
Pain score in 48 hours	48 hours	Pain score with the visualised analogue scale in 48 hours
Pain score in 72 hours	72 hours	Pain score with the visualised analogue scale in 72 hours
Total analgesic consumption	24 houra	Total analgesic consumption as rescue analgesia the first 24 hours

Secondary

Measure	Time frame	Description
Side effects	72 hours	All the side effects of the drug the first 72 hours

Countries

Greece

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 7, 2026