Total Knee ArthroplastyNCT01489631
Analgesia After Total Knee Replacement Surgery
A study testing naropin, marcaine and sufentanil in people with Total Knee Arthroplasty, run by St. Antonius Hospital at 1 site in Netherlands.
Trial summary
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Total Knee Arthroplasty
- What is being tested?
- naropin, marcaine and sufentanil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 81 participants
- Where
- 1 siteNetherlands
- Study dates
- Mar 2013to Apr 2014
- Phase
- Interventional
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18 years or older and legally responsible
- Waiting for total knee replacement surgery
- Informed consent
Who cannot join
- Contraindications for epidural analgesia
- Aortic Valve stenosis
- Severely compromised cardiac function
- infection near epidural punction site
- Redo knee surgery
- Previous arthrotomies
- Allergy/Hypersensitivity for study mediation or all other used medication
- Participation in other studies
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.
Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
Read the detailed description
Study design:
Prospective randomised study
Study population:
Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.
Intervention:
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.
Primary study parameters/outcome of the study:
NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.
Secondary study parameters/outcome of the study:
Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.
- Conditions
- Total Knee Arthroplasty
- Being tested
- naropin, marcaine, sufentanil, neurontin
- Keywords
- Epidural, Local infiltration, Knee, Arthroplasty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
naropinDrug
Also called ropivacaine
ropivacaine 0,2%, 3x 50 ml during surgery
marcaineDrug
Also called bupivacaine
bupivacaine 0,125%
sufentanilDrug
Also called sufenta forte
sufentanil 1mcg/ml
neurontinDrug
Also called gabapentin
gabapentin 600 mg pre-operative 3 dd 300 mg
| Study group | Role | What they receive |
|---|---|---|
| epidural analgesia | Active comparator | The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. Receives: Drug: marcaine; Drug: sufentanil |
| local infiltration | Active comparator | The second group will receive local infiltration with ropivacaine of the knee during surgery. Receives: Drug: naropin |
| local infiltration and gabapentin | Active comparator | The third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin. Receives: Drug: naropin; Drug: neurontin |
What is being measured
The primary outcome is the main question the study is designed to answer.
NRS score in rest
Measured: 3 days after surgery
Secondary outcomes (4)
Speed of mobilisation
Measured: 3 days after surgery
Postoperative morphine consumption
Daily morphine consumption (mg) per day
Measured: 3 days after surgery
NRS score during flexion exercise
Measured: 3 days after surgery
NRS score during walking exercise
Measured: 3 days after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2011 (estimated)
- Study startMar 2013
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Total Knee ArthroplastyStudies 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 N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 81 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Antonius Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Leon Timmerman, St. Antonius Hospital
- Investigators
- Leon Timmerman, MD, Principal investigator, AnesthesiologistLouis N Marting, MD, Principal investigator, Orthopedic surgeon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01489631
- Sponsor's protocol ID
- TKP-37796
- Status last verified
- Jun 2015
- First submitted
- 8 Dec 2011
- Last updated
- 8 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Intra-articular Infiltration and Gabapentin With Epidural Analgesia After Total Knee Replacement Surgery
- ClinicalTrials.gov ID
- NCT01489631
- Acronym / sponsor ID
- TKP-37796
- Conditions
- Total Knee Arthroplasty
- Keywords
- Epidural, Local infiltration, Knee, Arthroplasty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 81 participants (actual)
- Lead sponsor
- St. Antonius HospitalUniversity, hospital or other
- Study start
- Mar 2013
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 9 Dec 2011 (estimated)
- 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.
Postoperative pain after total knee replacement surgery is difficult to treat. Mobilisation and hospital discharge might be delayed. Recent research shows that intra-articular infiltration with local anesthetics and perioperative prescription of gabapentin can improve outcome.
Objective of the study: Comparison of mobilisation speed and postoperative NRS-scores of patients after total knee replacement surgery which is treated with epidural analgesia or peroperative infiltration of the knee. Appraisal of the value of gabapentin for reduction of postoperative opiate consumption.
Detailed description
Study design:
Prospective randomised study
Study population:
Patients aged eighteen years or older, in whom knee replacement surgery is indicated. They will have spinal anaesthesia and epidural analgesia if indicated by randomisation. They must not have contraindications for epidural analgesia or the used medication in this study.
Intervention:
The first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. The second group will receive local infiltration with ropivacaine of the knee during surgery. Half of these patients will additionally be treated with gabapentin.
Primary study parameters/outcome of the study:
NRS-score (11-scale Numeric Rating Scale in which 0 means no pain, and 10 means most pain imaginable) in rest.
Secondary study parameters/outcome of the study:
Speed of mobilisation, postoperative opiate consumption. NRS scores during flexion exercise of the knee and during walking exercise.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| epidural analgesia | Active comparator | Drug: marcaine, Drug: sufentanilThe first group will be treated with epidural analgesia. Before surgery the epidural catheter will be placed according to local guidelines. After the operation epidural infiltration with bupivacaine and sufentanil will be commenced. |
| local infiltration | Active comparator | Drug: naropinThe second group will receive local infiltration with ropivacaine of the knee during surgery. |
| local infiltration and gabapentin | Active comparator | Drug: naropin, Drug: neurontinThe third group will receive local infiltration with ropivacaine of the knee during surgery and will additionally be treated with gabapentin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18 years or older and legally responsible
- Waiting for total knee replacement surgery
- Informed consent
Key exclusion criteria (8 listed)
- Contraindications for epidural analgesia
- Aortic Valve stenosis
- Severely compromised cardiac function
- infection near epidural punction site
- Redo knee surgery
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 |
|---|---|---|
| naropinAlso: ropivacaineropivacaine 0,2%, 3x 50 ml during surgery | Drug | local infiltration, local infiltration and gabapentin |
| marcaineAlso: bupivacainebupivacaine 0,125% | Drug | epidural analgesia |
| sufentanilAlso: sufenta fortesufentanil 1mcg/ml | Drug | epidural analgesia |
| neurontinAlso: gabapentingabapentin 600 mg pre-operative 3 dd 300 mg | Drug | local infiltration and gabapentin |
Primary outcome
NRS score in rest
Time frame: 3 days after surgery
4 secondary outcomes
Speed of mobilisation
Time frame: 3 days after surgery
Postoperative morphine consumption
Time frame: 3 days after surgery
NRS score during flexion exercise
Time frame: 3 days after surgery
NRS score during walking exercise
Time frame: 3 days after surgery
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 8 Jun 2015.
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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.
Leon Timmerman, MD principal investigator
Anesthesiologist
Louis N Marting, MD principal investigator
Orthopedic surgeon
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing naropin, marcaine and sufentanil in people with Total Knee Arthroplasty, run by St. Antonius Hospital at 1 site in Netherlands.
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 3 inclusion and 8 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 8 Jun 2015. 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 Netherlands. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
NRS score in rest (time frame: 3 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Jun 2015.