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

Primary Purpose

Postoperative Pain, Pain, Acute

Status
Completed
Phase
Phase 2
Locations
Greece
Study Type
Interventional
Intervention
Dexketoprofen/tramadol (27mg/75mg)
Tramadol hydrochloride
Paracetamol
Ropivacaine Hydrochloride 7.5 MG/ML
Levobupivacaine Hydrochloride
Sponsored by
KAT General Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

45 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Elena Nikolakopoulou

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Group A

Group B

Arm Description

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.

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Side effects
All the side effects of the drug the first 72 hours

Full Information

First Posted
November 24, 2019
Last Updated
November 24, 2019
Sponsor
KAT General Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT04178109
Brief Title
Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
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).
Study Type
Interventional

2. Study Status

Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 10, 2019 (Actual)
Primary Completion Date
November 10, 2019 (Actual)
Study Completion Date
November 20, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
KAT General Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Pain, Acute

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
226 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Group B
Arm Type
Placebo Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexketoprofen/tramadol (27mg/75mg)
Intervention Description
Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
Intervention Type
Drug
Intervention Name(s)
Tramadol hydrochloride
Intervention Description
Patients in group B received IV tramadol 75mg every 8h
Intervention Type
Drug
Intervention Name(s)
Paracetamol
Intervention Description
Patients in group B received IV paracetamol 1g every 8h
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride 7.5 MG/ML
Intervention Description
300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients
Intervention Type
Drug
Intervention Name(s)
Levobupivacaine Hydrochloride
Intervention Description
10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
Primary Outcome Measure Information:
Title
Pain score in 8hours
Description
Pain score with the visualised analogue scale in 8hours
Time Frame
8 hours
Title
Pain score in 24hours
Description
Pain score with the visualised analogue scale in 24 hours
Time Frame
24 hours
Title
Pain score in 48 hours
Description
Pain score with the visualised analogue scale in 48 hours
Time Frame
48 hours
Title
Pain score in 72 hours
Description
Pain score with the visualised analogue scale in 72 hours
Time Frame
72 hours
Title
Total analgesic consumption
Description
Total analgesic consumption as rescue analgesia the first 24 hours
Time Frame
24 houra
Secondary Outcome Measure Information:
Title
Side effects
Description
All the side effects of the drug the first 72 hours
Time Frame
72 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Facility Information:
Facility Name
Elena Nikolakopoulou
City
Athens
State/Province
Kifissia
ZIP/Postal Code
14571
Country
Greece

12. IPD Sharing Statement

Plan to Share IPD
Yes

Learn more about this trial

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

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