Pain, PostoperativePhase 4NCT03493490
Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery
A Phase 4 study testing Neodolpasse and Diclofenac in people with Pain, Postoperative and Analgesic Adverse Reaction, run by Medical University of Vienna at 1 site in Austria.
Trial summary
The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Read more about this study
- Who is it for?
- Ages 18 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Pain, Postoperative, Analgesic Adverse Reaction, Cruciate Ligament Rupture
- What is being tested?
- Neodolpasse and Diclofenac
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteAustria
- Study dates
- 1 Mar 2018to 31 May 2019
- Phase
- Phase 4
- 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 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Elective cruciate ligament surgery
- Confirmed patient suitability for planned surgery
- Legally valid signed written informed consent provided
- Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding
- Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
- No known intolerabilities or hypersensitivities to any part of the IMP / control medication
Show all 19Show fewer
- No reoperation/revision within 6 months after the initial surgery
- Absence of history of abuse of analgesics or other drug
- No analgesics within 48 hours prior to surgery (surgery-related medication excluded)
- No current / recent (within 4 weeks prior to enrolment) experimental treatment
- No current / recent (within 4 weeks prior to enrolment) participation in another clinical study
- No foreseeable difficulties with regard to protocol compliance
- No known hypersensibility against the active ingredients diclofenac, orphenadrine, remifentanil, propofol, rocuronium, and hydromorphone
- No known hypersensibility against the other ingredients of the investigational medicinal product
- Absence of congestive heart failure classes 2 or higher according to the NYHA classification
- Absence of ischemic heart disease
- Absence of peripheral arterial occlusive disease
- Absence of cerebro-vascular disease
- Absence of significant risk factors for cardiovascular events (e.g., hypertension, hyperlipidaemia, type-2 diabetes, moderate smoking defined as consumation of 11 cigarettes or more per day)
Who cannot join
- Major complications during surgery possibly leading to problems in the handling of the PCA or subsequently with the experimental treatment
- Intolerable adverse events or any serious adverse event
- Severe violation of the clinical study protocol
- Withdrawal of patient informed consent
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery - an Exploratory Placebo-controlled Clinical Study to Investigate the Analgesic Properties of the Combination of Diclofenac and Orphenadrine Versus Diclofenac Alone.
The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.
Read the detailed description
The clinical study is planned as a double-blind, randomised, treatment-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion.
Patients who meet the inclusion and exclusion criteria will be enrolled to the clinical study and receive an enrolment number. The enrolment number will be a 4-digit number where the leftmost position will be zero ("0"). Enrolled patients will receive enrolment numbers starting at 0001, 0002, and so forth.
Only patients who were successfully randomized after surgery will continue the study protocol. All other patients will be regarded as screening failures. Successfully randomized patients will receive two infusions over 60 - 90 minutes with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device and will be allowed on demand analgetics as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low.
Anaesthesia will be induced with propofol (1.0-2.5 mg/kg), remifentanil (1 mcg/kg over minimum of 30s) and rocuronium (0.6mg/kg) and subsequently maintained with remifentail (0.25 - 1 mcg/kg/min), and sevoflurane. During skin suture, 7.5 mg piritramid will be administered. No nitrous oxide will be administered.
No other narcotics, analgesics, or sedatives than those described herein will be allowed. In case the surgical procedure mandates the use of additional and/or other narcotics, analgesics, or sedatives it shall be up to the investigator to decide on further treatment. However, in such case the patient will not be randomized and will be regarded as screening failure.
Randomization of the study patient takes place post-surgery as soon as the patient is able to cooperate adequatey. Ability to cooperate is defined as successful VAS assessment. At this time point the patient will be randomized and assigned her/his final randomisation number. The final randomisation number will be a 4-digit number where the leftmost position indicating the type of knee surgery performed. Patient undergoing surgery for cruciate ligament repair will receive randomisation numbers starting at 1001, 1002, and so forth. Patients undergoing knee replacement surgery will receive randomisation numbers starting at 2001, 2002, and so forth.
The first infusion of the investigational medicinal product will be started immediately after randomization. PCA will be established as soon as possible after the start of the first infusion of the investigational medicinal product but not later than 30 min after the start of the first infusion of the investigational medicinal product. A one-way PCA device (Vygon PCA-System) will be used. The PCA system is independent from any power supply and therefore both safe and reliable. The PCA system contains 20 mg Hydal® (hydromorphone) in 50 mL solvent. The PCA system parameters are fixed to a single bolus volume of 0.5 mL thus delivering 0.2 mg hydromorphone per bolus which equates to 2.0 mg piritramide or 1.5 mg morphine. Lock-out period of the PCA system used is fixed to 5 min.
All bolus injections will be recorded and added to the cumulative analgesic doses delivered by PCA.
- Being tested
- Neodolpasse, Diclofenac, Placebo
- Keywords
- Double-Blind Method, placebo-controlled, parallel-group, single-centre, exploratory clinical study
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NeodolpasseDrug
Patients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
DiclofenacDrug
Patients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
PlaceboDrug
Patients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours.
| Study group | Role | What they receive |
|---|---|---|
| Neodolpasse | Experimental | In the Neodolpasse® arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
Neodolpasse® Infusion Solution combines 75 mg (250 mL) of the NSAID diclofenac with 30 mg of the muscle-relaxant orphenadrine. Receives: Drug: Neodolpasse |
| Diclofenac | Active comparator | In the Diclofenac arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours.
The Infusion solution contains 75 mg (250 mL) of the NSAID diclofenac. Receives: Drug: Diclofenac |
| Placebo | Placebo comparator | In the Placebo arm patients receive two physiologic saline infusion (250 mL) over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg
amount of pca analgetic administered
Measured: within 24 hours
Secondary outcomes (1)
VAS-Scale: Pain relief will be tracked during the infusion periods and until 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS).
visual analogue scales (VAS) pain measured The pain VAS is a unidimensional measure of pain intensity, used to record patients' pain pain severity. The VAS used is a straight horizontal line of fixed length 100 mm and pople scored their Pain 0-100.
Measured: after 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Apr 2018
- Study start1 Mar 2018
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Medical University of ViennaThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomization of the study patient takes place pre-surgery. Successfully randomized patients will receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low, also in the placebo group.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 72 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Vienna
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Oliver Kimberger, Medical University of Vienna
- Investigators
- Oliver Kimberger, M.D., Principal investigator, Medical University of Vienna
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03493490
- Sponsor's protocol ID
- NDOL-001-2016
- Status last verified
- Mar 2023
- First submitted
- 16 Mar 2018
- Last updated
- 20 Mar 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001 Nov;13(7):524-39. doi: 10.1016/s0952-8180(01)00320-8.
PubMed 11704453Kehlet H. Synergism between analgesics. Ann Med. 1995 Apr;27(2):259-62. doi: 10.3109/07853899509031968.
PubMed 7632423Kornhuber J, Parsons CG, Hartmann S, Retz W, Kamolz S, Thome J, Riederer P. Orphenadrine is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist: binding and patch clamp studies. J Neural Transm Gen Sect. 1995;102(3):237-46. doi: 10.1007/BF01281158.
PubMed 8788072Hunskaar S, Berge OG, Hole K. Orphenadrine citrate increases and prolongs the antinociceptive effects of paracetamol in mice. Acta Pharmacol Toxicol (Copenh). 1986 Jul;59(1):53-9. doi: 10.1111/j.1600-0773.1986.tb00134.x.
PubMed 3766151Luetz A, Heymann A, Radtke FM, Chenitir C, Neuhaus U, Nachtigall I, von Dossow V, Marz S, Eggers V, Heinz A, Wernecke KD, Spies CD. Different assessment tools for intensive care unit delirium: which score to use? Crit Care Med. 2010 Feb;38(2):409-18. doi: 10.1097/CCM.0b013e3181cabb42.
PubMed 20029345
Study at a glance
From the registry record, last updated by the sponsor on 20 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Neodolpasse® Infusion Solution Versus Diclofenac 75 mg Infusion in the Treatment of Postoperative Pain After Elective Knee Surgery - an Exploratory Placebo-controlled Clinical Study to Investigate the Analgesic Properties of the Combination of Diclofenac and Orphenadrine Versus Diclofenac Alone.
- ClinicalTrials.gov ID
- NCT03493490
- Acronym / sponsor ID
- NDOL-001-2016
- Keywords
- Double-Blind Method, placebo-controlled, parallel-group, single-centre, exploratory clinical study
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 72 participants (actual)
- Lead sponsor
- Medical University of ViennaUniversity, hospital or other
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 10 Apr 2018 (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.
The clinical study is planned as a double-blind, randomised, placebo-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion. Included will be Patients receiving elective cruciate ligament surgery. The effectiveness will be measured by the use of additional analgesic medication via PCA during the first 24 hours postoperatively as well as by using a Visual Analogue Scale (VAS). Furthermore the local and systemic tolerability and safety of the clinical study medications (i.e. Neodolpasse® Infusion Solution and 75 mg diclofenac only infusion) will be assessed.
Detailed description
The clinical study is planned as a double-blind, randomised, treatment-controlled, parallel-group, single-centre exploratory clinical study with the aim to investigate the analgesic efficacy of the Neodolpasse® Infusion Solution in comparison to a 75 mg diclofenac only infusion.
Patients who meet the inclusion and exclusion criteria will be enrolled to the clinical study and receive an enrolment number. The enrolment number will be a 4-digit number where the leftmost position will be zero ("0"). Enrolled patients will receive enrolment numbers starting at 0001, 0002, and so forth.
Only patients who were successfully randomized after surgery will continue the study protocol. All other patients will be regarded as screening failures. Successfully randomized patients will receive two infusions over 60 - 90 minutes with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device and will be allowed on demand analgetics as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low.
Anaesthesia will be induced with propofol (1.0-2.5 mg/kg), remifentanil (1 mcg/kg over minimum of 30s) and rocuronium (0.6mg/kg) and subsequently maintained with remifentail (0.25 - 1 mcg/kg/min), and sevoflurane. During skin suture, 7.5 mg piritramid will be administered. No nitrous oxide will be administered.
No other narcotics, analgesics, or sedatives than those described herein will be allowed. In case the surgical procedure mandates the use of additional and/or other narcotics, analgesics, or sedatives it shall be up to the investigator to decide on further treatment. However, in such case the patient will not be randomized and will be regarded as screening failure.
Randomization of the study patient takes place post-surgery as soon as the patient is able to cooperate adequatey. Ability to cooperate is defined as successful VAS assessment. At this time point the patient will be randomized and assigned her/his final randomisation number. The final randomisation number will be a 4-digit number where the leftmost position indicating the type of knee surgery performed. Patient undergoing surgery for cruciate ligament repair will receive randomisation numbers starting at 1001, 1002, and so forth. Patients undergoing knee replacement surgery will receive randomisation numbers starting at 2001, 2002, and so forth.
The first infusion of the investigational medicinal product will be started immediately after randomization. PCA will be established as soon as possible after the start of the first infusion of the investigational medicinal product but not later than 30 min after the start of the first infusion of the investigational medicinal product. A one-way PCA device (Vygon PCA-System) will be used. The PCA system is independent from any power supply and therefore both safe and reliable. The PCA system contains 20 mg Hydal® (hydromorphone) in 50 mL solvent. The PCA system parameters are fixed to a single bolus volume of 0.5 mL thus delivering 0.2 mg hydromorphone per bolus which equates to 2.0 mg piritramide or 1.5 mg morphine. Lock-out period of the PCA system used is fixed to 5 min.
All bolus injections will be recorded and added to the cumulative analgesic doses delivered by PCA.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Randomization of the study patient takes place pre-surgery. Successfully randomized patients will receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours postoperatively. All patients will be provided with a PCA device as postoperative rescue medication. Consequently the possibility of an inadequate postoperative pain treatment in the study patients is very low, also in the placebo group.
| Arm | Type | Receives |
|---|---|---|
| Neodolpasse | Experimental | Drug: NeodolpasseIn the Neodolpasse® arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. Neodolpasse® Infusion Solution combines 75 mg (250 mL) of the NSAID diclofenac with 30 mg of the muscle-relaxant orphenadrine. |
| Diclofenac | Active comparator | Drug: DiclofenacIn the Diclofenac arm patients receive two infusions over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. The Infusion solution contains 75 mg (250 mL) of the NSAID diclofenac. |
| Placebo | Placebo comparator | Drug: PlaceboIn the Placebo arm patients receive two physiologic saline infusion (250 mL) over 30 minutes after fixation of the graft replacement and with a time interval of 8 hours each during the first 24 hours. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (19 listed)
- Elective cruciate ligament surgery
- Confirmed patient suitability for planned surgery
- Legally valid signed written informed consent provided
- Female patients are confirmed non-pregnant (negative pregnancy test) or not breast feeding
- Adequate renal function defined by a creatinine value lower than 1.80 mg/dL for male and ower than 1.50 mg/dL for female patients
Key exclusion criteria (4 listed)
- Major complications during surgery possibly leading to problems in the handling of the PCA or subsequently with the experimental treatment
- Intolerable adverse events or any serious adverse event
- Severe violation of the clinical study protocol
- Withdrawal of patient informed consent
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 |
|---|---|---|
| NeodolpassePatients will receive two infusions containing 75 mg diclofenac and 30 mg orphenadrine citrate 30 minutes after fixation of the graft replacement and with a time interval of 8 hours. | Drug | Neodolpasse |
| DiclofenacPatients will receive two infusions containing 75 mg diclofenac 30 minutes after fixation of the graft replacement and with a time interval of 8 hours. | Drug | Diclofenac |
| PlaceboPatients will receive two physiologic saline infusions 30 minutes after fixation of the graft replacement and with a time interval of 8 hours. | Drug | Placebo |
Primary outcome
PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg
Time frame: within 24 hours
amount of pca analgetic administered
1 secondary outcome
VAS-Scale: Pain relief will be tracked during the infusion periods and until 48 hours after the surgical intervention by using a Visual Analogue Scale (VAS).
Time frame: after 24 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 20 Mar 2023.
- Background: PubMed 11704453Jin F, Chung F. Multimodal analgesia for postoperative pain control. J Clin Anesth. 2001 Nov;13(7):524-39. doi: 10.1016/s0952-8180(01)00320-8.
- Background: PubMed 7632423Kehlet H. Synergism between analgesics. Ann Med. 1995 Apr;27(2):259-62. doi: 10.3109/07853899509031968.
- Background: PubMed 8788072Kornhuber J, Parsons CG, Hartmann S, Retz W, Kamolz S, Thome J, Riederer P. Orphenadrine is an uncompetitive N-methyl-D-aspartate (NMDA) receptor antagonist: binding and patch clamp studies. J Neural Transm Gen Sect. 1995;102(3):237-46. doi: 10.1007/BF01281158.
- Background: PubMed 3766151Hunskaar S, Berge OG, Hole K. Orphenadrine citrate increases and prolongs the antinociceptive effects of paracetamol in mice. Acta Pharmacol Toxicol (Copenh). 1986 Jul;59(1):53-9. doi: 10.1111/j.1600-0773.1986.tb00134.x.
- Background: PubMed 20029345Luetz A, Heymann A, Radtke FM, Chenitir C, Neuhaus U, Nachtigall I, von Dossow V, Marz S, Eggers V, Heinz A, Wernecke KD, Spies CD. Different assessment tools for intensive care unit delirium: which score to use? Crit Care Med. 2010 Feb;38(2):409-18. doi: 10.1097/CCM.0b013e3181cabb42.
- Individual participant dataSharing planned: Undecided
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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.
Oliver Kimberger, M.D. principal investigator
Medical University of Vienna
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Neodolpasse and Diclofenac in people with Pain, Postoperative and Analgesic Adverse Reaction, run by Medical University of Vienna at 1 site in Austria.
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 19 inclusion and 4 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 20 Mar 2023. 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 Austria. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
PCA-use: Total dose of PCA alangetics required over the first 24 hours post-surgery. Measured in mg (time frame: within 24 hours). 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 NCT03493490, which also lists 5 linked publications.
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 20 Mar 2023.