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).

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).

Study Overview

• Status: Completed
• Conditions: Postoperative Pain; Pain, Acute
• Intervention / Treatment: Drug: Dexketoprofen/tramadol (27mg/75mg); Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Levobupivacaine Hydrochloride; Drug: Tramadol hydrochloride; Drug: Paracetamol

• Study Type: Interventional
• Enrollment (Actual): 226
• Phase: Phase 2

Contacts and Locations

Study Locations

• Greece
  • Kifissia
    • Athens, Kifissia, Greece, 14571
      • Elena Nikolakopoulou

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Group A; Group A was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group A was given the oral combination dexketoprofen/tramadole (25mg/75mg) 2h after surgery every 8h for 72h.	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: 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
Placebo Comparator: Group B; Group B was under spinal anesthesia with a 25G cutting edge needle with levobupivacaine 10-15mg and fentanyl 10μg. Periarticular injection was done by the surgeon with a dilition of 100ml N/S 0,9% with 300mg ropivacaine and 0,5mg epinephrine. Group B received postoperative analgesia with intravenous tramadole 75mg and paracetamol 1g every 8h with the first dose beginning 2h after the end of the surgery. For 72h	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; 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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: KAT General Hospital

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2019
• Primary Completion (Actual): November 10, 2019
• Study Completion (Actual): November 20, 2019

Study Registration Dates

• First Submitted: November 24, 2019
• First Submitted That Met QC Criteria: November 24, 2019
• First Posted (Actual): November 26, 2019

Study Record Updates

• Last Update Posted (Actual): November 26, 2019
• Last Update Submitted That Met QC Criteria: November 24, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Acute Pain; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Antipyretics; Analgesics, Opioid; Narcotics; Anesthetics, Local; Acetaminophen; Ropivacaine; Tramadol; Levobupivacaine; Dexketoprofen trometamol
• Other Study ID Numbers: 17200

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No