Arthroscopic Knee SurgeryPhase 4NCT02001662
Adductor Canal Block and Arthroscopic Knee Surgery, High Pain Responders
A Phase 4 study testing Intervention group, block no. 1 - Ropivacain in people with Arthroscopic Knee Surgery, run by Glostrup University Hospital, Copenhagen at 1 site in Denmark.
Trial summary
The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Arthroscopic Knee Surgery
- What is being tested?
- Intervention group, block no. 1 - Ropivacain
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteDenmark
- Study dates
- May 2013to Nov 2013
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent
Who cannot join
- Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Amager Hospital, University of Copenhagen, Denmark
Copenhagen, Copenhagen, Amager, 2300
About this study
Official title: The Analgesic Efficacy of the Adductor Canal Blockade in High Pain Responders After Arthroscopic Knee Surgery - a Randomized Clinical Trial
The investigators want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.
- Conditions
- Arthroscopic Knee Surgery
- Being tested
- Intervention group, block no. 1 - Ropivacain, Control group: 1. block - saline
- Keywords
- Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft), High pain responders, Adductore Canal Block, Analgesics, Ultrasound guided nerve block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention group, block no. 1 - RopivacainProcedure or surgery
Intervention group: 1. block ropivacaine - 2. block saline
Control group: 1. block - salineProcedure or surgery
Control group: 1. block saline - 2. block ropivacaine
| Study group | Role | What they receive |
|---|---|---|
| Intervention group, block no. 1 - Ropivacain | Experimental | Adductor-Canal-Block no.1: 30mL ropivacaine (7.5 mg/ml) when postoperative VAS-score is > 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee.
Adductor-Canal-Block no.2: after 45 min (t45) - 30mL isotonic saline. Receives: Procedure: Intervention group, block no. 1 - Ropivacain |
| Control group, block no. 1 - saline | Sham comparator | Adductor-Canal-Block no.1: 30mL isotonic saline when postoperative VAS-score is above 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee.
Adductor-Canal-Block no.2: after 45 min (t45) - 30mL ropivacaine (7.5 mg/ml) Receives: Procedure: Control group: 1. block - saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain score during 45 degree flexion of the knee
Pain score during flexion of the knee 45 min. after nerve block
Measured: 45 minutes after nerve block
Secondary outcomes (3)
Pain score
pain score at rest: time 0,15,30,45,60,75,90 min. after first nerve block pain score during flexion of the knee: time 0,15,30,45,60,75,90 min. after first nerve block pain score during mobilisation (5m walk): 45 and 90 min after nerve block
Measured: 0-90 min. after first nerveblock
muscle strength
patients accesses muscle strength during walk
Measured: 45 and 90 min after nerve block
Opioid consumption
Measured: 0-90 min after nerve block
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2013 (estimated)
- Study startMay 2013
- Primary completionNov 2013
- Study completionNov 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Arthroscopic Knee SurgeryStudies 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
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Glostrup University Hospital, Copenhagen
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Malene Espelund, Glostrup University Hospital, Copenhagen
- Investigators
- Malene Espelund, MD, Principal investigator, Glostrup University Hospital, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02001662
- Sponsor's protocol ID
- SM3-ME-13
- Other IDs
- 2013-000663-83, H-3-2013-039
- Status last verified
- Dec 2013
- First submitted
- 9 Apr 2013
- Last updated
- 6 Dec 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Analgesic Efficacy of the Adductor Canal Blockade in High Pain Responders After Arthroscopic Knee Surgery - a Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT02001662
- Acronym / sponsor ID
- SM3-ME-13
- Conditions
- Arthroscopic Knee Surgery
- Keywords
- Minor arthroscopic knee surgery including ACL-reconstruction (hamstrins graft), High pain responders, Adductore Canal Block, Analgesics, Ultrasound guided nerve block
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Glostrup University Hospital, CopenhagenUniversity, hospital or other
- Study start
- May 2013
- Primary completion
- Nov 2013 (actual)
- Study completion
- Nov 2013 (actual)
- First posted
- 5 Dec 2013 (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 want to explore the analgesic effect of Adductor Canal Blockade (a peripheral nerve block) in high pain responding patients after arthroscopic knee surgery. The investigators hypothesize that the nerve block will have an abrupt analgesic effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group, block no. 1 - Ropivacain | Experimental | Procedure: Intervention group, block no. 1 - RopivacainAdductor-Canal-Block no.1: 30mL ropivacaine (7.5 mg/ml) when postoperative VAS-score is > 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee. Adductor-Canal-Block no.2: after 45 min (t45) - 30mL isotonic saline. |
| Control group, block no. 1 - saline | Sham comparator | Procedure: Control group: 1. block - salineAdductor-Canal-Block no.1: 30mL isotonic saline when postoperative VAS-score is above 40mm (on a 0-100 mm VAS-scale) during a 45 degree active flexion of the knee. Adductor-Canal-Block no.2: after 45 min (t45) - 30mL ropivacaine (7.5 mg/ml) |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Arthroscopic knee surgery, if reconstruction of Anterior Cruciate Ligament only hamstring graft 18-80 years of age BMI 18-40 ASA I-III written Consent
Key exclusion criteria (1 listed)
- Unable to communicate in danish, allergic reactions toward any study medication pregnancy alcohol/drug abuse daily opioid consumption scin infection (injection site)
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 |
|---|---|---|
| Intervention group, block no. 1 - RopivacainIntervention group: 1. block ropivacaine - 2. block saline | Procedure or surgery | Intervention group, block no. 1 - Ropivacain |
| Control group: 1. block - salineControl group: 1. block saline - 2. block ropivacaine | Procedure or surgery | Control group, block no. 1 - saline |
Primary outcome
Pain score during 45 degree flexion of the knee
Time frame: 45 minutes after nerve block
Pain score during flexion of the knee 45 min. after nerve block
3 secondary outcomes
Pain score
Time frame: 0-90 min. after first nerveblock
muscle strength
Time frame: 45 and 90 min after nerve block
Opioid consumption
Time frame: 0-90 min after nerve block
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 6 Dec 2013.
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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.
Malene Espelund, MD principal investigator
Glostrup University Hospital, University of Copenhagen
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 Intervention group, block no. 1 - Ropivacain in people with Arthroscopic Knee Surgery, run by Glostrup University Hospital, 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 1 inclusion and 1 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 6 Dec 2013. 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. 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?
Pain score during 45 degree flexion of the knee (time frame: 45 minutes after nerve block). 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 6 Dec 2013.