Postoperative PainPhase 4NCT02539628
Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption
A Phase 4 study testing ropivacaine 0.2% in people with Postoperative Pain, run by Pia Jaeger at 1 site in Denmark.
Trial summary
The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- ropivacaine 0.2%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 110 participants
- Where
- 1 siteDenmark
- Study dates
- Mar 2015to Sep 2016
- 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 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
- American society of anesthesiologists 1-3
- Ability to perform a timed up and go 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.
Denmark1 site
Department of Anaesthesia-Surgery-Intensive Care, Gentofte Hospital
Gentofte Municipality, Hellerup, 2900
About this study
Official title: Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study
The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.
- Conditions
- Postoperative Pain
- Being tested
- ropivacaine 0.2%
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaine 0.2%Drug
Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM
| Study group | Role | What they receive |
|---|---|---|
| Intermittent bolus | Experimental | ropivacaine 0.2%, 21 ml every 3 hours Receives: Drug: ropivacaine 0.2% |
| Continuous infusion | Active comparator | ropivacaine 0.2%, 7ml/h Receives: Drug: ropivacaine 0.2% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total opioid consumption
Difference in total opioid consumption (patient controlled analgesia pump and any potential rescue administration) between groups, from end of surgery until 12 pm on postoperative day (POD) 2.
Measured: 2 days postoperative
Secondary outcomes (7)
Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)
Visual analogue scale (VAS) pain scores (0-100 mm) during 45 degrees active knee flexion analyzed using a linear mixed model with the inclusion of all time points (Day of surgery (DOS): 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Measured: 2 days postoepratively
Pain at rest as assessed by the VAS pain scores
VAS pain scores (0-100 mm) at rest analyzed using a linear mixed model with the inclusion of all time points (DOS: 8 pm, POD 1: 8 am, 12 pm, 8 pm, POD 2: 8 am and 12 pm).
Measured: 2 days postoperatively
Pain during the Timed Up and Go test as assessed by the VAS
Worst pain (VAS, 0-100 mm) during the Timed Up and Go test at 12 pm on POD 1 and 2.
Measured: 1 and 2 days postoperatively
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2.
Measured: 1 and 2 days postoperatively
Timed Up and Go test
Time (seconds) to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Measured: 1 and 2 days postoperatively
Number of patients able to perform the Timed Up and Go test
Number of patients able to perform the Timed Up and Go test at 12 pm on POD 1 and 2.
Measured: 1 and 2 days postoperatively
6 min walk test
Distance ambulated (m) during the 6 min walk test performed at 12 pm on POD 1 and 2.
Measured: 1 and 2 days postoperativley
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Sep 2015 (estimated)
- Study startMar 2015
- Primary completionSep 2016
- Study completionSep 2016
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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 110 participants (actual)
Sponsor and investigators
- Lead sponsor
- Pia Jaeger
- Sponsor type
- University, hospital or other
- Collaborators
- University of California, San Diego, Bispebjerg Hospital, Smiths Medical, ASD, Inc.
- Responsible party
- Sponsor-investigator, Pia Jaeger, Copenhagen University Hospital, Rigshospitalet
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02539628
- Sponsor's protocol ID
- SM3-PJ-14
- Other IDs
- 2014-005642-22, 2014
- Status last verified
- Apr 2017
- First submitted
- 13 Mar 2015
- Last updated
- 28 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.
PubMed 29293181
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Triple-masked, Controlled Study
- ClinicalTrials.gov ID
- NCT02539628
- Acronym / sponsor ID
- SM3-PJ-14
- Conditions
- Postoperative Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 110 participants (actual)
- Lead sponsor
- Pia JaegerUniversity, hospital or other
- Collaborators
- University of California, San Diego, Bispebjerg Hospital, Smiths Medical, ASD, Inc.
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2016 (actual)
- First posted
- 3 Sep 2015 (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.
The investigators believe sufficient spread to all nerves within the adductor canal-and thereby sufficient analgesia-can only be obtained by bolus injections and not by continuous infusions via a catheter. The aim of the study is to investigate whether an adductor canal block performed as repeated intermittent boluses provides superior pain relief to continuous infusion. The investigators hypothesize that adductor canal block performed as intermittent boluses via a catheter will reduce morphine consumption and pain as well as enhance ambulation and muscle strength compared with continuous infusion.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intermittent bolus | Experimental | Drug: ropivacaine 0.2%ropivacaine 0.2%, 21 ml every 3 hours |
| Continuous infusion | Active comparator | Drug: ropivacaine 0.2%ropivacaine 0.2%, 7ml/h |
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 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
- American society of anesthesiologists 1-3
- Ability to perform a timed up and go 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 |
|---|---|---|
| ropivacaine 0.2%Adductor canal block. Placed immediately postoperative. Intervention stops on POD2 12PM | Drug | Continuous infusion, Intermittent bolus |
Primary outcome
Total opioid consumption
Time frame: 2 days postoperative
Difference in total opioid consumption (patient controlled analgesia pump and any potential rescue administration) between groups, from end of surgery until 12 pm on postoperative day (POD) 2.
7 secondary outcomes
Pains scores during knee flexion as assessed by the Visual analogue scale (VAS)
Time frame: 2 days postoepratively
Pain at rest as assessed by the VAS pain scores
Time frame: 2 days postoperatively
Pain during the Timed Up and Go test as assessed by the VAS
Time frame: 1 and 2 days postoperatively
Quadriceps strength assessed as maximum voluntary isometric contraction in percentage of preoperative baseline values at 12 pm on POD 1 and 2
Time frame: 1 and 2 days postoperatively
Timed Up and Go test
Time frame: 1 and 2 days postoperatively
Number of patients able to perform the Timed Up and Go test
Time frame: 1 and 2 days postoperatively
6 min walk test
Time frame: 1 and 2 days postoperativley
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 28 Apr 2017.
- Derived from this study: PubMed 29293181Jaeger P, Baggesgaard J, Sorensen JK, Ilfeld BM, Gottschau B, Graungaard B, Dahl JB, Odgaard A, Grevstad U. Adductor Canal Block With Continuous Infusion Versus Intermittent Boluses and Morphine Consumption: A Randomized, Blinded, Controlled Clinical Trial. Anesth Analg. 2018 Jun;126(6):2069-2077. doi: 10.1213/ANE.0000000000002747.
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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 4 study testing ropivacaine 0.2% in people with Postoperative Pain, run by Pia Jaeger 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 28 Apr 2017. 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: 2 days postoperative). 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 NCT02539628, 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 28 Apr 2017.