Peripheral Nerve InjuriesNCT02786888
Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle
An observational study of Peripheral Nerve Injuries, run by University of Utah at 1 site in United States.
Trial summary
Early ambulation after knee replacement surgery is made possible in large part by providing safe and effective pain control. Peripheral nerve blocks are increasingly used for postoperative analgesia since they can provide excellent pain relief and minimize the need for opioid analgesics. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Peripheral Nerve Injuries
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 1 May 2016to 1 May 2017
- Phase
- Observational
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients for elective knee arthroplasty
Who may be able to join
- all TKA patients
Who cannot join
- refuse nerve block
Trial locations and contacts
1 site in 1 country.
About this study
Early ambulation after knee replacement surgery is made possible in large part by providing safe and effective pain control. Peripheral nerve blocks are increasingly used for postoperative analgesia since they can provide excellent pain relief and minimize the need for opioid analgesics.
Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists at the University of Utah. This block is unique in that it spares motor function in the lower extremity. Since 2009, a number of publications have described the successful use of ACB for pain management after total knee arthroplasty (TKA), anterior cruciate ligament (ACL) reconstruction, and other procedures of the knee. As a component of multi-modal analgesia, ACB can provide effective postoperative pain control and facilitate early hospital discharge.
Read more
Although it is widely utilized, the ACB block can be technically difficult to perform since it requires injection in immediate proximity to the femoral artery and vein. In patients with a large thigh circumference, ultrasound can be challenging since the femoral vessels are deeper and more difficult to visualize. This presents the possibility of vessel trauma and/or intravascular injection of local anesthetic.
The investigators have implemented a new technique for performing the ACB. This block is performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm. Injection through the fenestrated needle produces effective distribution of local anesthetic to nerves of the adductor canal without immediate proximity to the femoral artery and vein. The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible even in patients with very large thigh circumference.
In summary, early experience with the US guided ACB block performed with a fenestrated block needle suggests that it is technically easier and potentially safer to perform than blocks performed with a conventional needle.
This study should be performed prospectively in order to ensure accurate data comparing the two needles. A retrospective review of blocks performed using a conventional needle would not provide accurate data with respect to the number of attempts, time required to perform the blocks or the resulting sensory changes after performing the nerve block.
Read the detailed description
A new fenestrated (multiple side-ports) needle has recently been cleared by the FDA for performing peripheral nerve blocks. Experience with this needle suggests that it can make ACB technically easier and safer to perform.This is due in large part because it eliminates the need to position the needle in close proximity to large blood vessels in the thigh.
The objectives for this study would be to prospectively compare nerve blocks performed for postoperative analgesia performed using conventional (single bevel) needles to those performed using the fenestrated needle. Specifically, the investigators would compare metrics such as; time to perform the block, number of attempts, unintentional blood vessel puncture, and successful injection rates. Successful injection rates would be quantified by comparing the distribution of sensory loss after each injection. Those injections resulting in a loss of sensation over the skin surfaces innervated by nerves of the adductor canal would be judged to be "successful". An absence of sensory change in these surfaces would be judged as "unsuccessful".
Procedures:
All patients will be randomized to receive treatment with one of two nerve block needles. Neither the investigators nor the patients will be blinded. Randomization will be based solely on the results of a computer generated random sequence.
All patients participating in the study will receive the same anesthetic, surgery, postoperative care, and pain management that is provided currently for patients (including those not enrolled in this study protocol) having knee replacement at the University of Utah. This investigation is designed to compare only the efficacy of two needle designs that are currently used and FDA approved for peripheral nerve block.
Patients consenting to participate in the study will be randomized to receive an ACB performed with either a single bevel (conventional) or a fenestrated needle. The ACB will be placed in the preoperative holding area approximately 30 minutes before being transported to the operating room. During performance of the nerve block, the time to complete the nerve block, the number of attempts used to complete the nerve block, the incidence of blood vessel puncture and/or blood aspiration will be recorded for each case. All patients will also be assessed for sensory changes in the lower extremity as a metric for block efficacy.
In the operating room, patients will be anesthetized using a spinal block and will receive intravenous sedation at the discretion of the attending anesthesiologist.
During the postoperative period, the quality and duration of analgesia will be primary metrics used to compare the two study needles. Specifically, numerical pain scores reported by the patients and opioid consumption will be compared for both groups.
All patients for whom the is a possible "failed nerve block" will be offered a repeat "rescue" nerve block after surgery. A failed block would be defined by an absence of sensory changes in the extremity associated with poor pain control reported by the patient.
Additional metrics for comparison would be the time to ambulation after surgery and the time to hospital discharge.
Statistical Methods, Data Analysis and Interpretation
The study will be prospective and randomized for two groups of patients having nerve blocks as part of their pain management protocol for total knee replacement.
- Conditions
- Peripheral Nerve Injuries
- Medical subject headings
- Peripheral Nerve Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| conventional needle | conventional needle used | |
| fenestrated needle | fenestrated needle used |
What is being measured
The primary outcome is the main question the study is designed to answer.
The efficiency in performing nerve block
The number of attempts during block placement as well as the number of times the needle must be repositioned during block placement. This will simply be recorded as a whole number by the study nurse. The number of unintended vascular punctures observed by a study nurse will be recorded.
Measured: this metric will be obtained while the nerve block is being performed
Secondary outcomes (1)
pain control as a measure of nerve block effectiveness will be recorded using a verbal analog scale between 1 and 10. Opioid requirements will be recorded as a total number of milligrams received.
the pain scores and opioid requirements resulting after surgery
Measured: this metric will be recorded during the first 24 hours after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2016 (estimated)
- Study start1 May 2016
- Primary completion1 May 2017
- Study completion1 May 2017
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 Peripheral Nerve InjuriesStudies of the same condition, open and under way.
- More trials run by University of UtahThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeff Swenson, University of Utah
- Investigators
- Jeff Swenson, M.D., Principal investigator, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02786888
- Sponsor's protocol ID
- IRB 00090426
- Status last verified
- Oct 2017
- First submitted
- 17 May 2016
- Last updated
- 26 Oct 2017
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Swenson JD, Pollard JE, Peters CL, Anderson MB, Pace NL. Randomized controlled trial of a simplified adductor canal block performed for analgesia following total knee arthroplasty. Reg Anesth Pain Med. 2019 Mar;44(3):348-353. doi: 10.1136/rapm-2018-100070. Epub 2019 Jan 23.
PubMed 30679333
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Comparison of Adductor Canal Block Performed With a Multiport Versus Single Bevel Needle
- ClinicalTrials.gov ID
- NCT02786888
- Acronym / sponsor ID
- IRB 00090426
- Conditions
- Peripheral Nerve Injuries
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Study start
- 1 May 2016 (actual)
- Primary completion
- 1 May 2017 (actual)
- Study completion
- 1 May 2017 (actual)
- First posted
- 1 Jun 2016 (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.
Early ambulation after knee replacement surgery is made possible in large part by providing safe and effective pain control. Peripheral nerve blocks are increasingly used for postoperative analgesia since they can provide excellent pain relief and minimize the need for opioid analgesics.
Ultrasound guided adductor canal block (ACB) was first reported in 2009 by anesthesiologists at the University of Utah. This block is unique in that it spares motor function in the lower extremity. Since 2009, a number of publications have described the successful use of ACB for pain management after total knee arthroplasty (TKA), anterior cruciate ligament (ACL) reconstruction, and other procedures of the knee. As a component of multi-modal analgesia, ACB can provide effective postoperative pain control and facilitate early hospital discharge.
Although it is widely utilized, the ACB block can be technically difficult to perform since it requires injection in immediate proximity to the femoral artery and vein. In patients with a large thigh circumference, ultrasound can be challenging since the femoral vessels are deeper and more difficult to visualize. This presents the possibility of vessel trauma and/or intravascular injection of local anesthetic.
The investigators have implemented a new technique for performing the ACB. This block is performed using a 20G fenestrated needle. The needle is FDA approved for peripheral nerve block. It has an occluded tip with 8 side ports on alternating sides of the distal 2cm. Injection through the fenestrated needle produces effective distribution of local anesthetic to nerves of the adductor canal without immediate proximity to the femoral artery and vein. The ultrasound landmarks used to perform ACB with the fenestrated needle are readily visible even in patients with very large thigh circumference.
In summary, early experience with the US guided ACB block performed with a fenestrated block needle suggests that it is technically easier and potentially safer to perform than blocks performed with a conventional needle.
This study should be performed prospectively in order to ensure accurate data comparing the two needles. A retrospective review of blocks performed using a conventional needle would not provide accurate data with respect to the number of attempts, time required to perform the blocks or the resulting sensory changes after performing the nerve block.
Detailed description
A new fenestrated (multiple side-ports) needle has recently been cleared by the FDA for performing peripheral nerve blocks. Experience with this needle suggests that it can make ACB technically easier and safer to perform.This is due in large part because it eliminates the need to position the needle in close proximity to large blood vessels in the thigh.
The objectives for this study would be to prospectively compare nerve blocks performed for postoperative analgesia performed using conventional (single bevel) needles to those performed using the fenestrated needle. Specifically, the investigators would compare metrics such as; time to perform the block, number of attempts, unintentional blood vessel puncture, and successful injection rates. Successful injection rates would be quantified by comparing the distribution of sensory loss after each injection. Those injections resulting in a loss of sensation over the skin surfaces innervated by nerves of the adductor canal would be judged to be "successful". An absence of sensory change in these surfaces would be judged as "unsuccessful".
Procedures:
All patients will be randomized to receive treatment with one of two nerve block needles. Neither the investigators nor the patients will be blinded. Randomization will be based solely on the results of a computer generated random sequence.
All patients participating in the study will receive the same anesthetic, surgery, postoperative care, and pain management that is provided currently for patients (including those not enrolled in this study protocol) having knee replacement at the University of Utah. This investigation is designed to compare only the efficacy of two needle designs that are currently used and FDA approved for peripheral nerve block.
Patients consenting to participate in the study will be randomized to receive an ACB performed with either a single bevel (conventional) or a fenestrated needle. The ACB will be placed in the preoperative holding area approximately 30 minutes before being transported to the operating room. During performance of the nerve block, the time to complete the nerve block, the number of attempts used to complete the nerve block, the incidence of blood vessel puncture and/or blood aspiration will be recorded for each case. All patients will also be assessed for sensory changes in the lower extremity as a metric for block efficacy.
In the operating room, patients will be anesthetized using a spinal block and will receive intravenous sedation at the discretion of the attending anesthesiologist.
During the postoperative period, the quality and duration of analgesia will be primary metrics used to compare the two study needles. Specifically, numerical pain scores reported by the patients and opioid consumption will be compared for both groups.
All patients for whom the is a possible "failed nerve block" will be offered a repeat "rescue" nerve block after surgery. A failed block would be defined by an absence of sensory changes in the extremity associated with poor pain control reported by the patient.
Additional metrics for comparison would be the time to ambulation after surgery and the time to hospital discharge.
Statistical Methods, Data Analysis and Interpretation
The study will be prospective and randomized for two groups of patients having nerve blocks as part of their pain management protocol for total knee replacement.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| conventional needle | – | –conventional needle used |
| fenestrated needle | – | –fenestrated needle used |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients for elective knee arthroplasty
Key inclusion criteria (1 listed)
- all TKA patients
Key exclusion criteria (1 listed)
- refuse nerve block
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
The efficiency in performing nerve block
Time frame: this metric will be obtained while the nerve block is being performed
The number of attempts during block placement as well as the number of times the needle must be repositioned during block placement. This will simply be recorded as a whole number by the study nurse. The number of unintended vascular punctures observed by a study nurse will be recorded.
1 secondary outcome
pain control as a measure of nerve block effectiveness will be recorded using a verbal analog scale between 1 and 10. Opioid requirements will be recorded as a total number of milligrams received.
Time frame: this metric will be recorded during the first 24 hours after surgery
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 26 Oct 2017.
- Derived from this study: PubMed 30679333Swenson JD, Pollard JE, Peters CL, Anderson MB, Pace NL. Randomized controlled trial of a simplified adductor canal block performed for analgesia following total knee arthroplasty. Reg Anesth Pain Med. 2019 Mar;44(3):348-353. doi: 10.1136/rapm-2018-100070. Epub 2019 Jan 23.
- Individual participant dataSharing planned: No
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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.
Jeff Swenson, M.D. principal investigator
University of Utah
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Peripheral Nerve Injuries, run by University of Utah at 1 site in United States.
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 26 Oct 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 United States. 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 efficiency in performing nerve block (time frame: this metric will be obtained while the nerve block is being performed). 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 NCT02786888, 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 26 Oct 2017.