Anterior Cruciate Ligament InjuryNCT03130049
Popliteal Plexus Block for Postoperative Pain After ACL Reconstruction
A study testing Popliteal plexus block in people with Anterior Cruciate Ligament Injury and Postoperative Pain, run by University of Aarhus at 2 sites in Denmark.
Trial summary
The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative pain in patients undergoing anterior cruciate ligament (ACL) reconstruction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anterior Cruciate Ligament Injury, Postoperative Pain
- What is being tested?
- Popliteal plexus block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesDenmark
- Study dates
- 27 Sep 2017to 4 Dec 2017
- 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
- Patients undergoing ACL reconstruction on one of the two trial sites
- Age ≥ 18
- American Society of Anesthesiologists (ASA) status I-III
- Informed consent
Who cannot join
- Patients unable to cooperate
- Patients not able to speak Danish or with other communication problems
- Pregnancy
- Contraindication towards any medical product used in the study
- Preoperatively reduced sensation on the medial and lateral part of the lower leg
- Patients with diabetes requiring medical treatment
- Preoperative intake of opioids (dosed > once daily)
- ACL revision
Trial locations and contacts
2 sites in 1 country.
Denmark2 sites
Aarhus University Hospital
Aarhus C, 8000
The Regional Hospital in Horsens
Horsens, 8700
About this study
Official title: The Effect of the Popliteal Plexus Block on Postoperative Pain After Reconstruction of the Anterior Cruciate Ligament
The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Read the detailed description
Postoperative pain following ACL reconstruction can be alleviated with an ultrasound-guided femoral triangle block (FTB). However, it is the investigators' observation that 10-20 % of the patients still complain of intense pain localized in the center of the knee.
Cadaver dissection studies have shown that an injection into the distal part of the adductor canal will spread to the popliteal fossa, and one dissection study showed consistent spread to the popliteal plexus.
The study team hypothesized that a PPB will reduce the postoperative pain, when it is used as a supplement to the FTB in patients undergoing ACL reconstruction.
- Being tested
- Popliteal plexus block
- Keywords
- Peripheral nerve block, Ultrasound
- Medical subject headings
- Anterior Cruciate Ligament Injuries, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Popliteal plexus blockProcedure or surgery
10 mL Marcain-adrenalin 5 mg/mL + 5 microgram/mL. Ultrasound-guided injection into the distal part of the adductor canal
| Study group | Role | What they receive |
|---|---|---|
| Patients with postoperative pain, NRS >3 | Experimental | Patients reporting postoperative pain (NRS >3) localized to the center of the knee (10 patients) will receive a popliteal plexus block Receives: Procedure: Popliteal plexus block |
| Patients with postoperative pain, NRS ≤ 3 | No intervention | (approx. 90 patients) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The effect of the popliteal plexus block (PPB)
Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS ≤ 3 after the PPB
Measured: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Secondary outcomes (4)
Percentage of patients with central knee pain
The percentage of patients with FTB reporting pain (NRS >3) localized in the center of the knee in the observation period
Measured: Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
Onset time for PPB
Time from withdrawal of the needle until patient reports NRS ≤ 3
Measured: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
The effect of the PPB on cutaneous sensation
Tested on the lateral part of the lower leg (pinprick test)
Measured: Baseline, 30 and 60 minutes after PPB
The effect of the PPB on muscle strength
Dorsal flexion and plantar flexion in the ankle joint, measured with a handheld dynamometer)
Measured: Baseline, 60 minutes after PPB
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2017
- Study start27 Sep 2017
- Primary completion4 Dec 2017
- Study completion4 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Anterior Cruciate Ligament InjuryStudies of the same condition, open and under way.
- More trials run by University of AarhusThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Pilot study
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan M Jensen, MD, Principal investigator, Aarhus University HospitalChristian Jessen, MD, Principal investigator, The Regional Hospital in Horsens
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03130049
- Sponsor's protocol ID
- Protokol_PPB_ACL_21042017
- Status last verified
- Apr 2017
- First submitted
- 23 Apr 2017
- Last updated
- 23 Jan 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
PubMed 28002228Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
PubMed 27685346Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
PubMed 25376972Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.
PubMed 27442773
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of the Popliteal Plexus Block on Postoperative Pain After Reconstruction of the Anterior Cruciate Ligament
- ClinicalTrials.gov ID
- NCT03130049
- Acronym / sponsor ID
- Protokol_PPB_ACL_21042017
- Keywords
- Peripheral nerve block, Ultrasound
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 27 Sep 2017 (actual)
- Primary completion
- 4 Dec 2017 (actual)
- Study completion
- 4 Dec 2017 (actual)
- First posted
- 26 Apr 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.
The study aims to investigate the effect of the popliteal plexus block (PPB) on postoperative pain in patients undergoing anterior cruciate ligament (ACL) reconstruction.
Detailed description
Postoperative pain following ACL reconstruction can be alleviated with an ultrasound-guided femoral triangle block (FTB). However, it is the investigators' observation that 10-20 % of the patients still complain of intense pain localized in the center of the knee.
Cadaver dissection studies have shown that an injection into the distal part of the adductor canal will spread to the popliteal fossa, and one dissection study showed consistent spread to the popliteal plexus.
The study team hypothesized that a PPB will reduce the postoperative pain, when it is used as a supplement to the FTB in patients undergoing ACL reconstruction.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Pilot study
| Arm | Type | Receives |
|---|---|---|
| Patients with postoperative pain, NRS >3 | Experimental | Procedure: Popliteal plexus blockPatients reporting postoperative pain (NRS >3) localized to the center of the knee (10 patients) will receive a popliteal plexus block |
| Patients with postoperative pain, NRS ≤ 3 | No intervention | –(approx. 90 patients) |
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 undergoing ACL reconstruction on one of the two trial sites
- Age ≥ 18
- American Society of Anesthesiologists (ASA) status I-III
- Informed consent
Key exclusion criteria (8 listed)
- Patients unable to cooperate
- Patients not able to speak Danish or with other communication problems
- Pregnancy
- Contraindication towards any medical product used in the study
- Preoperatively reduced sensation on the medial and lateral part of the lower leg
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 |
|---|---|---|
| Popliteal plexus block10 mL Marcain-adrenalin 5 mg/mL + 5 microgram/mL. Ultrasound-guided injection into the distal part of the adductor canal | Procedure or surgery | Patients with postoperative pain, NRS >3 |
Primary outcome
The effect of the popliteal plexus block (PPB)
Time frame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
Evaluated as the percentage of patients with postoperative pain NRS >3, dropping in pain score to NRS ≤ 3 after the PPB
4 secondary outcomes
Percentage of patients with central knee pain
Time frame: Pain scores: 15, 30, 45 and 60 minutes after arrival at the post anesthesia care unit (PACU)
Onset time for PPB
Time frame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB
The effect of the PPB on cutaneous sensation
Time frame: Baseline, 30 and 60 minutes after PPB
The effect of the PPB on muscle strength
Time frame: Baseline, 60 minutes after PPB
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 23 Jan 2018.
- Background: PubMed 28002228Wong WY, Bjorn S, Strid JM, Borglum J, Bendtsen TF. Defining the Location of the Adductor Canal Using Ultrasound. Reg Anesth Pain Med. 2017 Mar/Apr;42(2):241-245. doi: 10.1097/AAP.0000000000000539.
- Background: PubMed 27685346Bendtsen TF, Moriggl B, Chan V, Borglum J. The Optimal Analgesic Block for Total Knee Arthroplasty. Reg Anesth Pain Med. 2016 Nov/Dec;41(6):711-719. doi: 10.1097/AAP.0000000000000485.
- Background: PubMed 25376972Grevstad U, Mathiesen O, Valentiner LS, Jaeger P, Hilsted KL, Dahl JB. Effect of adductor canal block versus femoral nerve block on quadriceps strength, mobilization, and pain after total knee arthroplasty: a randomized, blinded study. Reg Anesth Pain Med. 2015 Jan-Feb;40(1):3-10. doi: 10.1097/AAP.0000000000000169.
- Background: PubMed 27442773Goffin P, Lecoq JP, Ninane V, Brichant JF, Sala-Blanch X, Gautier PE, Bonnet P, Carlier A, Hadzic A. Interfascial Spread of Injectate After Adductor Canal Injection in Fresh Human Cadavers. Anesth Analg. 2016 Aug;123(2):501-3. doi: 10.1213/ANE.0000000000001441.
- 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.
Jan M Jensen, MD principal investigator
Aarhus University Hospital
Christian Jessen, MD principal investigator
The Regional Hospital in Horsens
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Popliteal plexus block in people with Anterior Cruciate Ligament Injury and Postoperative Pain, run by University of Aarhus at 2 sites 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 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 23 Jan 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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.
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?
The effect of the popliteal plexus block (PPB) (time frame: Pain scores (NRS): 15, 30, 45 and 60 minutes after PPB). 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 NCT03130049, which also lists 4 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 23 Jan 2018.