Pain ManagementPhase 4NCT03142789
Adductor Canal Block After Total Knee Replacement - a Suture-method Catheter vs a Standard Catheter vs a Single Bolus
A Phase 4 study testing Initial bolus (Certa and standard catheter groups), Initial bolus (Single bolus group) and Intermittent boluses (Certa and standard catheter groups) in people with Pain Management, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
Trial summary
In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain Management
- What is being tested?
- Initial bolus (Certa and standard catheter groups), Initial bolus (Single bolus group) and Intermittent boluses (Certa and standard catheter groups)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 153 participants
- Where
- 1 siteDenmark
- Study dates
- 9 May 2017to 12 Apr 2018
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
- Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
- ASA 1-3
- Ability to perform a TUG test preoperatively
Who cannot join
- Patients who cannot cooperate
- Patients who cannot understand or speak Danish.
- Patients with allergy to the medicines used in the study
- Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
- Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
- Rheumatoid arthritis
Show all 9Show fewer
- BMI > 40
- Neuromuscular pathology in the lower limbs
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Analgesic Effect of an ACB (Adductor Canal Block) Using a New Suture-method Catheter vs a Standard Perineural Catheter vs a Single Bolus: A Randomized, Blinded, Controlled Study
In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.
Read the detailed description
The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypothesis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard catheter.
- Conditions
- Pain Management
- Being tested
- Initial bolus (Certa and standard catheter groups), Initial bolus (Single bolus group), Intermittent boluses (Certa and standard catheter groups), Intermittent boluses (Single bolus group)
- Keywords
- Pain, Total knee arthroplasty, Regional anesthesia
- Medical subject headings
- Agnosia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Initial bolus (Certa and standard catheter groups)Drug
10 ml of ropivacaine 0,75% will be used to ensure correct position of the needle and to expand the adductor canal, followed by injection of another 10 ml of ropivacaine 0.75% via the catheter during real time US imaging to ensure correct placement of the catheter.
Initial bolus (Single bolus group)Drug
20 ml of ropivacaine 0.75%
Intermittent boluses (Certa and standard catheter groups)Drug
20 ml of ropivacaine 0.2% every 8 hour in the catheter
Intermittent boluses (Single bolus group)Drug
0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter
| Study group | Role | What they receive |
|---|---|---|
| Certa Catheter | Active comparator | A Certa-catheter (suture method) is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed. Receives: Drug: Initial bolus (Certa and standard catheter groups); Drug: Intermittent boluses (Certa and standard catheter groups) |
| Standard Catheter | Active comparator | A Standard-catheter is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view.
A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2.
2 dressings will be applied (medial and lateral) to obscure which catheter has been placed. Receives: Drug: Initial bolus (Certa and standard catheter groups); Drug: Intermittent boluses (Certa and standard catheter groups) |
| Single Bolus | Active comparator | A bolus of ropivacaine will be injected into the adductor canal, at the midthigh level, using a 80 mm x 22G Pajunk needle during real time US imaging (initial bolus).
A sham catheter (25 Certa and 25 standard catheters according to randomi-zation) will be fixed externally and covered by dressings as in the catheter groups groups (Certa and standard). Care will be taken to use approximately the same amount of time as used in the catheter groups (Certa and standard) An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses into the dressing every 8 hour until 12 PM on POD2. Receives: Drug: Initial bolus (Single bolus group); Drug: Intermittent boluses (Single bolus group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
- Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC)
Measured: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)
Secondary outcomes (7)
VAS (Visual analog scale) flexion
VAS pain score (0-100mm) during 45 degrees active knee flexion
Measured: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU (Postoperative Care Unit), at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.
VAS rest
VAS pain score (0-100mm) during rest
Measured: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.
VAS-TUG (Time-Up-and-Go-Test)
Worst VAS pain score (0-100mm) during Timed-Up-and-Go test
Measured: 12 (noon) on POD 1 and 2
TUG-test
Timed-Up-and-Go test
Measured: 12 (noon) on POD 1 and 2
6 minutes walk test
How many meters the patient can walk (using a high 4-wheel walker) in 6 minutes
Measured: 12 (noon) on POD 1 and 2
MVIC (Maximum Voluntary Isometric Contraction)
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values.
Measured: Preoperatively and at 12 (noon) on POD 1 and 2
TUG test, patient number
Number of patients able to perform the TUG test using a high 4-wheel walker
Measured: 12 (noon) on POD 1 and 2
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 May 2017
- Study start9 May 2017
- Primary completion12 Apr 2018
- Study completion12 Apr 2018
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 Pain ManagementStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study is performed as a blinded, randomized, controlled study. Randomization will be based on a computer-generated block randomization list in a 1:1:1 ratio, block sizes of 9. A person, not otherwise involved in the study, will prepare the randomization list and keep it, locked away in a secure place. 2 sets of consecutively numbered, sealed, opaque, code envelopes will be prepared by the same person.
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 153 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Gentofte, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ulrik Grevstad, University Hospital, Gentofte, Copenhagen
- Investigators
- Ulrik Grevstad, MD, phd, Principal investigator, Gentofte Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03142789
- Sponsor's protocol ID
- EudraCT number: 2016-005069-30
- Status last verified
- Apr 2018
- First submitted
- 1 May 2017
- Last updated
- 1 May 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: We have not yet decided whether IPD will be made available to other researchers
Publications
Lyngeraa TS, Jaeger P, Gottschau B, Graungaard B, Rossen-Jorgensen AM, Toftegaard I, Grevstad U. Comparison of the analgesic effect of an adductor canal block using a new suture-method catheter vs. standard perineural catheter vs. single-injection: a randomised, blinded, controlled study. Anaesthesia. 2019 Nov;74(11):1397-1405. doi: 10.1111/anae.14814. Epub 2019 Aug 29.
PubMed 31465115
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Analgesic Effect of an ACB (Adductor Canal Block) Using a New Suture-method Catheter vs a Standard Perineural Catheter vs a Single Bolus: A Randomized, Blinded, Controlled Study
- ClinicalTrials.gov ID
- NCT03142789
- Acronym / sponsor ID
- EudraCT number: 2016-005069-30
- Conditions
- Pain Management
- Keywords
- Pain, Total knee arthroplasty, Regional anesthesia
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 153 participants (actual)
- Lead sponsor
- University Hospital, Gentofte, CopenhagenUniversity, hospital or other
- Study start
- 9 May 2017 (actual)
- Primary completion
- 12 Apr 2018 (actual)
- Study completion
- 12 Apr 2018 (actual)
- First posted
- 5 May 2017 (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.
In this study we wish to investigate the analgesic effect of the administration of 0.2% ropivacaine for an adductor canal block as repeated boluses (20 ml every 8 hours) through a new suture-method catheter or a standard perineural catheter compared with a single bolus (20 ml), in patients following primary total knee arthroplasty.
Detailed description
The aim of the study is to compare the clinical effects of three different administration forms for an ACB: repeated intermittent boluses through a Certa catheter (CC) versus repeated boluses through a standard catheter (through the needle) (SC) versus a single bolus (SB). Our dual hypothesis is that repeated boluses through a catheter (either Certa or standard catheter) reduces opioid consumption (primary outcome), as well as reduces pain scores, enhances ambulation and muscle strength compared with a single bolus, and that the Certa catheter is superior to a standard catheter.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
- Model description
- The study is performed as a blinded, randomized, controlled study. Randomization will be based on a computer-generated block randomization list in a 1:1:1 ratio, block sizes of 9. A person, not otherwise involved in the study, will prepare the randomization list and keep it, locked away in a secure place. 2 sets of consecutively numbered, sealed, opaque, code envelopes will be prepared by the same person.
| Arm | Type | Receives |
|---|---|---|
| Certa Catheter | Active comparator | Drug: Initial bolus (Certa and standard catheter groups), Drug: Intermittent boluses (Certa and standard catheter groups)A Certa-catheter (suture method) is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view. A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2. 2 dressings will be applied (medial and lateral) to obscure which catheter has been placed. |
| Standard Catheter | Active comparator | Drug: Initial bolus (Certa and standard catheter groups), Drug: Intermittent boluses (Certa and standard catheter groups)A Standard-catheter is inserted under ultrasound guidance at the midthigh level in the adductor canal, using an in plane technique, short/oblique axis view. A bolus of ropivacaine will be administered during real time US imaging to ensure correct placement of the catheter (initial bolus). An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses every 8 hours until 12 pm on POD2. 2 dressings will be applied (medial and lateral) to obscure which catheter has been placed. |
| Single Bolus | Active comparator | Drug: Initial bolus (Single bolus group), Drug: Intermittent boluses (Single bolus group)A bolus of ropivacaine will be injected into the adductor canal, at the midthigh level, using a 80 mm x 22G Pajunk needle during real time US imaging (initial bolus). A sham catheter (25 Certa and 25 standard catheters according to randomi-zation) will be fixed externally and covered by dressings as in the catheter groups groups (Certa and standard). Care will be taken to use approximately the same amount of time as used in the catheter groups (Certa and standard) An infusion pump will be connected immediately following catheter insertion, delivering intermittent boluses into the dressing every 8 hour until 12 PM on POD2. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients scheduled for unilateral total knee arthroplasty in spinal anesthesia
- Patients who gave their written informed consent to participating in the study after having fully understood the contents of the protocol and restrictions
- ASA 1-3
- Ability to perform a TUG test preoperatively
Key exclusion criteria (9 listed)
- Patients who cannot cooperate
- Patients who cannot understand or speak Danish.
- Patients with allergy to the medicines used in the study
- Patients with a daily intake of strong opioids (morphine, oxycodone, ketobemidone, methadone, fentanyl) during the last 4 weeks
- Patients suffering from alcohol and/or drug abuse - based on the investigator's assessment
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 |
|---|---|---|
| Initial bolus (Certa and standard catheter groups)10 ml of ropivacaine 0,75% will be used to ensure correct position of the needle and to expand the adductor canal, followed by injection of another 10 ml of ropivacaine 0.75% via the catheter during real time US imaging to ensure correct placement of the catheter. | Drug | Certa Catheter, Standard Catheter |
| Initial bolus (Single bolus group)20 ml of ropivacaine 0.75% | Drug | Single Bolus |
| Intermittent boluses (Certa and standard catheter groups)20 ml of ropivacaine 0.2% every 8 hour in the catheter | Drug | Certa Catheter, Standard Catheter |
| Intermittent boluses (Single bolus group)0.1ml of ropivacaine 0.2% every 8 hour in the sham catheter | Drug | Single Bolus |
Primary outcome
Total opioid consumption
Time frame: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)
• Total opioid consumption (PCA pump and any potential rescue administration) between groups (SB vs CC, SB vs SC and CC vs SC)
7 secondary outcomes
VAS (Visual analog scale) flexion
Time frame: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU (Postoperative Care Unit), at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.
VAS rest
Time frame: o Pain is recorded preoperatively before administration of medication, and postoperatively at the PACU, at 8 PM on the day of surgery, at 8 AM, 12 (noon) and 8 PM on POD 1 and finally at 8 AM and 12 (noon) on POD 2.
VAS-TUG (Time-Up-and-Go-Test)
Time frame: 12 (noon) on POD 1 and 2
TUG-test
Time frame: 12 (noon) on POD 1 and 2
6 minutes walk test
Time frame: 12 (noon) on POD 1 and 2
MVIC (Maximum Voluntary Isometric Contraction)
Time frame: Preoperatively and at 12 (noon) on POD 1 and 2
TUG test, patient number
Time frame: 12 (noon) on POD 1 and 2
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 1 May 2018.
- Derived from this study: PubMed 31465115Lyngeraa TS, Jaeger P, Gottschau B, Graungaard B, Rossen-Jorgensen AM, Toftegaard I, Grevstad U. Comparison of the analgesic effect of an adductor canal block using a new suture-method catheter vs. standard perineural catheter vs. single-injection: a randomised, blinded, controlled study. Anaesthesia. 2019 Nov;74(11):1397-1405. doi: 10.1111/anae.14814. Epub 2019 Aug 29.
- Individual participant dataSharing planned: Undecided. We have not yet decided whether IPD will be made available to other researchers
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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.
Ulrik Grevstad, MD, phd principal investigator
Gentofte Hospital
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 Initial bolus (Certa and standard catheter groups), Initial bolus (Single bolus group) and Intermittent boluses (Certa and standard catheter groups) in people with Pain Management, run by University Hospital, Gentofte, Copenhagen at 1 site in Denmark.
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 4 inclusion and 9 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 1 May 2018. 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 Denmark. 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.
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?
Total opioid consumption (time frame: from end of surgery until 12 (noon) on POD 2 (Postoperative Day)). 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 NCT03142789, 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 1 May 2018.