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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04178109
• Other study ID #: 17200
• Status: Completed
• Phase: Phase 2
• Start date: January 10, 2019
• Est. completion date: November 20, 2019

Study information

• Verified date: November 2019
• Source: KAT General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 226
• Est. completion date: November 20, 2019
• Est. primary completion date: November 10, 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 80 Years

Eligibility

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,?gt)

• heart failure

• history of gastrointestinal bleeding

Related Conditions & MeSH terms

• Acute Pain
• Pain, Acute
• Pain, Postoperative
• Postoperative Pain

Intervention

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

Locations

Country	Name	City	State
Greece	Elena Nikolakopoulou	Athens	Kifissia

Sponsors (1)

Lead Sponsor	Collaborator
KAT General Hospital

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain score in 8hours	Pain score with the visualised analogue scale in 8hours	8 hours
Primary	Pain score in 24hours	Pain score with the visualised analogue scale in 24 hours	24 hours
Primary	Pain score in 48 hours	Pain score with the visualised analogue scale in 48 hours	48 hours
Primary	Pain score in 72 hours	Pain score with the visualised analogue scale in 72 hours	72 hours
Primary	Total analgesic consumption	Total analgesic consumption as rescue analgesia the first 24 hours	24 houra
Secondary	Side effects	All the side effects of the drug the first 72 hours	72 hours