Postoperative PainPhase 2NCT04178109
Oral Use of Dexketoprofen/Tramadol for Acute Postoperative Pain in Total Hip Replacement With a Direct Anterior Approach.
A Phase 2 study testing Dexketoprofen/tramadol (27mg/75mg), Tramadol hydrochloride and Paracetamol in people with Postoperative Pain and Pain, Acute, run by KAT General Hospital at 1 site in Greece.
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. Read more about this study
- Who is it for?
- Ages 45 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain, Pain, Acute
- What is being tested?
- Dexketoprofen/tramadol (27mg/75mg), Tramadol hydrochloride and Paracetamol
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 226 participants
- Where
- 1 siteGreece
- Study dates
- 10 Jan 2019to 20 Nov 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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).
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
- Being tested
- Dexketoprofen/tramadol (27mg/75mg), Tramadol hydrochloride, Paracetamol, Ropivacaine Hydrochloride 7.5 MG/ML, Levobupivacaine Hydrochloride
- Medical subject headings
- Pain, Postoperative, Acute Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen/tramadol (27mg/75mg)Drug
Postoperatively patients in Group A received the oral combination dexketoprofen/tramadol for the treatment of acute postoperative pain the first 72h
Tramadol hydrochlorideDrug
Patients in group B received IV tramadol 75mg every 8h
ParacetamolDrug
Patients in group B received IV paracetamol 1g every 8h
Ropivacaine Hydrochloride 7.5 MG/MLDrug
300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients
Levobupivacaine HydrochlorideDrug
10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia
| Study group | Role | What they receive |
|---|---|---|
| Group A | Active comparator | 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. Receives: Drug: Dexketoprofen/tramadol (27mg/75mg); Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Levobupivacaine Hydrochloride |
| Group B | Placebo comparator | 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 Receives: Drug: Tramadol hydrochloride; Drug: Paracetamol; Drug: Ropivacaine Hydrochloride 7.5 MG/ML; Drug: Levobupivacaine Hydrochloride |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score in 8hours
Pain score with the visualised analogue scale in 8hours
Measured: 8 hours
Pain score in 24hours
Pain score with the visualised analogue scale in 24 hours
Measured: 24 hours
Pain score in 48 hours
Pain score with the visualised analogue scale in 48 hours
Measured: 48 hours
Pain score in 72 hours
Pain score with the visualised analogue scale in 72 hours
Measured: 72 hours
Total analgesic consumption
Total analgesic consumption as rescue analgesia the first 24 hours
Measured: 24 houra
Secondary outcomes (1)
Side effects
All the side effects of the drug the first 72 hours
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2019
- Study start10 Jan 2019
- Primary completion10 Nov 2019
- Study completion20 Nov 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 226 participants (actual)
Sponsor and investigators
- Lead sponsor
- KAT General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Elena Nikolakopoulou, KAT General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04178109
- Sponsor's protocol ID
- 17200
- Status last verified
- Nov 2019
- First submitted
- 24 Nov 2019
- Last updated
- 26 Nov 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes
Publications
Macheras GA, Tzefronis D, Argyrou C, Nikolakopoulou E, Galvez Miravete A, Karachalios TS. Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol. Hip Int. 2024 May;34(3):304-310. doi: 10.1177/11207000231219797. Epub 2024 Jan 10.
PubMed 38204364
Study at a glance
From the registry record, last updated by the sponsor on 26 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT04178109
- Acronym / sponsor ID
- 17200
- Conditions
- Postoperative Pain, Pain, Acute
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 226 participants (actual)
- Lead sponsor
- KAT General HospitalUniversity, hospital or other
- Study start
- 10 Jan 2019 (actual)
- Primary completion
- 10 Nov 2019 (actual)
- Study completion
- 20 Nov 2019 (actual)
- First posted
- 26 Nov 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Active comparator | Drug: Dexketoprofen/tramadol (27mg/75mg), Drug: Ropivacaine Hydrochloride 7.5 MG/ML, Drug: Levobupivacaine HydrochlorideGroup 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 | Placebo comparator | Drug: Tramadol hydrochloride, Drug: Paracetamol, Drug: Ropivacaine Hydrochloride 7.5 MG/ML, Drug: Levobupivacaine HydrochlorideGroup 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 |
Who may qualify
- Ages
- 45 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- allergy to any given drugs
- contraindications for spinal anesthesia
- active bleeding
- renal failure ( gfr< 90ml/h)
- hepatic failure ( abnormal sgot,sgpt,γgt)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Group A |
| Tramadol hydrochloridePatients in group B received IV tramadol 75mg every 8h | Drug | Group B |
| ParacetamolPatients in group B received IV paracetamol 1g every 8h | Drug | Group B |
| Ropivacaine Hydrochloride 7.5 MG/ML300mg ropivacaine as periarticular injection in a dilution of 100ml n/s 0,9% was done by the orthopedic surgeon in all patients | Drug | Group A, Group B |
| Levobupivacaine Hydrochloride10-15mg levobupivacaine was done subarachnoidal for spinal anesthesia | Drug | Group A, Group B |
Primary outcome
Pain score in 8hours
Time frame: 8 hours
Pain score with the visualised analogue scale in 8hours
Pain score in 24hours
Time frame: 24 hours
Pain score with the visualised analogue scale in 24 hours
Pain score in 48 hours
Time frame: 48 hours
Pain score with the visualised analogue scale in 48 hours
Pain score in 72 hours
Time frame: 72 hours
Pain score with the visualised analogue scale in 72 hours
Total analgesic consumption
Time frame: 24 houra
Total analgesic consumption as rescue analgesia the first 24 hours
1 secondary outcome
Side effects
Time frame: 72 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Nov 2019.
- Derived from this study: PubMed 38204364Macheras GA, Tzefronis D, Argyrou C, Nikolakopoulou E, Galvez Miravete A, Karachalios TS. Pain management after total hip arthroplasty: comparative study of analgesic efficacy and tolerability between oral tramadol/dexketoprofen and injectable paracetamol + tramadol. Hip Int. 2024 May;34(3):304-310. doi: 10.1177/11207000231219797. Epub 2024 Jan 10.
- Individual participant dataSharing planned: Yes
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dexketoprofen/tramadol (27mg/75mg), Tramadol hydrochloride and Paracetamol in people with Postoperative Pain and Pain, Acute, run by KAT General Hospital at 1 site in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Nov 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain score in 8hours (time frame: 8 hours). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04178109, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Nov 2019.