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Pain, PostoperativeNCT03145584

Continuous Versus Single-Shot Adductor Canal Block in Total Knee Arthroplasty

A study testing Continuous Bupivacaine via Adductor Canal Saphenous Catheter and Single Shot Adductor Canal Saphenous Block with Bupivacaine in people with Pain, Postoperative, run by University College Cork at 1 site in Ireland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block has recently been shown to improve the pain control of patients following TKA. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Pain, Postoperative
What is being tested?
Continuous Bupivacaine via Adductor Canal Saphenous Catheter and Single Shot Adductor Canal Saphenous Block with Bupivacaine
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
40 participants
Where
1 siteIreland
Study dates
Jul 2015to 31 Dec 2015
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

  • Scheduled unilateral total knee arthroplasty,
  • ASA physical status I to III,
  • age > 18 years.

Who cannot join

  • Body Mass Index >35,
  • pre-existing lower extremity neurologic abnormalities,
  • infection, history of chronic opioid use,
  • pregnancy, contraindications to peripheral nerve block or central neuraxial blockade,
  • allergy or contraindications to local anesthetics or drugs that would be used for multimodal analgesia,
  • inadequate command of English
  • refusal of spinal anaesthetic

Trial locations and contacts

1 site in 1 country.

Ireland1 site
  • Brian O'Donnell

    Cork

Other trials in Ireland

About this study

Official title: A Comparison of the Effects of Continuous and Single-Shot Adductor Canal Blocks on Analgesia and Knee Flexion Following Total Knee Arthroplasty

Pain following total knee arthroplasty (TKA) is associated with delayed recovery, impaired mobility, increased morbidity, longer hospital stay and greater cost. Adductor canal block has recently been shown to improve the pain control of patients following TKA. It is not known whether a single shot technique or a continuous catheter-based infusion technique provides optimal analgesia. The investigators hypothesize that a continuous technique would provide better analgesia and permit patients to achieve objective measures of recovery following TKA than a single shot technique.

Read the detailed description

Introduction

Total knee Arthroplasty (TKA) is the standard treatment for knee osteoarthritis, which affects millions of people world wide. In 2008, more than 600,000 TKAs were performed in the United States. This number represents more than double the number performed in 1999 and is estimated to increase by more than 500 % (from the 1999 value) by 2020.

Severe postoperative pain occurs in 60% and moderate pain in 30% of patients undergoing TKA. In addition, the intensity of acute postoperative pain correlates with the risk of developing a persistent post surgical pain which can be chronic and debilitating. Thus, the management of pain following TKA is an important determinant of a patient's long term functional outcome. In addition, recovery from TKA requires extensive and effective postoperative physiotherapy (PT), itself a painful event following TKA. Physiotherapy ensures good range of motion and prevents complications such as tissue retraction, adhesion formation and muscle atrophy, all of which may compromise achievement of long term recovery milestones. Thus, the anesthesiologist caring for patients undergoing TKA attempts to provide a postoperative analgesic regimen which ensures that the patient is as pain free as possible while ensuring that the patient has sufficient motor strength to participate actively in PT.

The need to find non-narcotic alternatives for post surgical pain management has become even more urgent recently due to the recent epidemic of narcotic-related deaths. In the United States the number of opioid related deaths since 1999 has reached almost half a million which represents a four fold increase in incidence, and at least half of opioid related deaths involve prescription drugs. Hence effective non-narcotic approaches to pain management hold great importance not only for clinical care but also for public health on a larger scale.

Previously, intravenous, intrathecal or oral opioids were the mainstay of postoperative analgesia following TKA. Although variably effective, the resulting analgesia is associated with well recognized adverse effects including nausea, vomiting, pruritus and sedation. Each adverse effect is unpleasant and likely to impede recovery and participation in PT. Epidural catheters and femoral nerve blocks have both been used for postoperative analgesia in this setting, but each is associated with lower limb motor weakness which hinders early implementation of PT and may increase the risk of falls.

Recently, adductor canal block (ACB) has been reported as an effective means of providing post-operative analgesia for TKA. The ACB is not a new block, having been first described by van der Wal over 20 years ago. The adductor canal block, in the context of analgesia following TKA, is relatively recent, being first described by Tsai et al in 2010. Infiltration of local anesthetic into the adductor canal blocks primarily the saphenous nerve, a sensory nerve, which supplies the medial and anteromedial aspects of the knee via an infra patellar branch.

Postoperative pain following TKA extends well beyond the 8-12 hour duration of a single bolus injection of local anesthetic. Continuous peripheral nerve blockade (PNB) can facilitate early discharge and better rehabilitation in the early postoperative period. In addition, PNB decreases opioid consumption, its associated side effects and is also associated with greater patient satisfaction .

The investigators hypothesized that patients receiving continuous adductor canal block would achieve a greater degree of active knee flexion on POD 2 following TKA than those who receive a single injection ACB.

METHODS Subjects With Institutional ethical approval from the Clinical Research Ethics Committee of the Cork Teaching Hospitals, 40 consecutive patients scheduled for unilateral Total Knee Arthroplasty who met the study criteria and provided written informed consent, were enrolled in a double blind, randomized clinical trial.

Patients were randomly allocated to receive either an ACB followed by catheter placement (n=20) or an adductor canal block followed by sham catheter placement (n=20). The sham catheter was placed on the surface of the leg and covered by an opaque dressing to conceal the insertion site. (A similar dressing was placed on real catheter insertions to conceal group assignment from both patient and assessor.) All patients had the proximal end of their catheter attached to a Pajunk 350 ml FuserPump (FuserPumps are portable elastomeric infusion pumps) concealed in opaque bags to prevent patients and assessors from determining which pumps were actually functioning. These pumps function without a motor and so make no sound. Computer generated randomization was performed for patient group assignment at the time of enrolment in the study. Randomization assignments were done in blocks of 10 in a 1:1 ratio with assignments placed in sealed numbered opaque envelopes. Only the anesthesiologist responsible for performing the block was aware of the group to which a given patient was assigned. The researchers responsible for data collection were unaware of the group to which each patient was assigned .

Preoperative Preparation Potential patients were provided information on the study during the preoperative physiotherapy assessment several weeks before their scheduled surgery. At this time, baseline values for knee flexion and the TUG test were obtained. On the day of surgery, after obtaining written informed consent, patients were assigned to a study group by attaching a sealed randomization envelope to their charts.

After registration on the day of surgery patients were brought to the pre-anesthetic area where IV cannulation was performed and standard anesthetic monitors applied. Patients received intravenous sedation prior to placement of the spinal anesthetic at the discretion of the responsible consultant anesthesiologist. A spinal anesthetic was performed under standard aseptic conditions in the usual fashion. The choice of local anesthetic (either isobaric bupivacaine 0.5% or hyperbaric bupivacaine 0.5%.) used to perform the spinal anesthetic was at the discretion of the responsible consultant anesthesiologist.

Intraoperative Period Patients received intraoperative sedation at the discretion of the consultant anesthesiologist using fentanyl, midazolam and propofol as deemed clinically appropriate. At the conclusion of the procedure, the patients received 30 ml 0.5% bupivacaine diluted with 70 ml 0.9% saline local infiltration analgesia (LIA) injected into the layers of soft tissue around the knee joint by the surgeon. .

Postoperative Period All blocks were performed in the Post Anaesthesia Care Unit immediately after surgery with standard anesthetic monitoring and an IV cannula in place. No subcutaneous local anesthetic or sedation were required as the spinal anesthetic was still effective. All patients received an adductor canal block under ultrasound guidance using a high frequency probe at the mid thigh level. After appropriate asepsis local anesthesia to the skin was placed at the level of the mid femur on the medial aspect of the thigh. Using ultrasound guidance (General Electric Venue 40, 3050 Lake Drive, Citywest Business Campus, Dublin 24, Ireland) with a high frequency L12 linear transducer the femoral artery was visualized in cross section and the ultrasound needle (B Braun Contiplex D ultrasound needle and catheter set, B Braun Melsungen AG, 34209 Melsungen, Germany) placed using in-plane visualization below the Sartorius muscle and just lateral to the femoral artery and medial to the Vastus Medialis. All patients received an injection of bupivacaine 0.5% 10 ml. For patients allocated to receive a continuous infusion postoperatively, a catheter was inserted immediately after injection of the initial bolus of local anesthetic. Patients allocated to the single injection group received the injection of local anesthetic followed by placement of a sham catheter on the skin, covered with a large opaque dressing. (Figure 3) In both groups, patients' catheters were attached to the concealed in opaque bags. The sham pumps were filled with normal saline. The pumps containing local anesthetic contained 0.15625% bupivacaine 350 ml were set to run at 8 ml/ hour (the equivalent of 0.125 % bupivacaine running at 10 ml/hour) All blocks were placed by Consultant anesthesiologists with fellowship training in Regional Anaesthesia.

All patients received multimodal oral analgesia which included Paracetamol 1g po every 6 hours, oxycodone (oxycontin) po twice a day (10 mg/dose for patients >70 years and 20 mg/dose for those <70 years) , pregabalin 50 mg po 3 times a day, and oxycodone (oxynorm) 5-10mg 4 hourly po as required for breakthrough pain (Pain score > 4/10)

Recordings and Measurements Research personnel unaware of patient randomization performed all clinical assessments. General Demographic data collected included: age, gender, height, weight, American Society of Anesthesiologists (ASA) Status and BMI.

Assessment of block function was made by checking for sensory changes to pain and temperature (using a blunt needle and ethyl chloride spray) in the distribution of the saphenous nerve at 20:00 on POD 0. A functioning adductor canal block with bupivacaine will last at least 8-12 hours. Thus all blocks,( i.e. both with and without a continuous infusion) were anticipated to still be effective at 20:00H on the day of surgery, as no blocks were performed before 10 AM. Decreased sensation in the extremity receiving the block compared with the unblocked one at the level of the medial malleolus was accepted as evidence of a functioning block.

Adverse Events Each day the assessor inquired about complications that could be attributable to the study, such as patient falls or symptoms or signs of local anesthetic toxicity. Any such events were documented. The common adverse effects of opioids (i.e. nausea, vomiting) were not recorded. However, there were no episodes of respiratory depression that required resuscitation.

Statistical Methodology Sample size was determined based on an unpublished retrospective review of knee flexion in patients who had undergone TKA at the investigators institution having received a single injection ACB. From this review, a mean maximum knee flexion of 82 (SD = 2) degrees on the second day postoperatively was assumed. A 20% difference in knee flexion was considered to be clinically significant. To achieve an 80% power and to detect a 20% difference in knee flexion with a 2-sided Type I error rate of 0.05, the calculated minimum sample was 9 patients per group. To prevent loss of power due to early withdrawal of patients, incomplete data, non-functional adductor canal blocks and absence of statistical information on a comparable continuous infusion group, 20 patients in each were included group. General demographic data in both groups were compared using unpaired, two tailed t-tests for independent samples for continuous variables, and the Chi squared test (or Fisher's Exact test as appropriate) for categorical variables. Basic statistical tools were employed to describe the data: mean, median and standard deviation. Cumulative oxycodone consumption was compared between groups using analysis of covariance (ANCOVA) adjusted for age, gender and ASA status.

Being tested
Continuous Bupivacaine via Adductor Canal Saphenous Catheter, Single Shot Adductor Canal Saphenous Block with Bupivacaine
Keywords
Total Knee Arthroplasty, Physiotherapy
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Continuous Bupivacaine via Adductor Canal Saphenous CatheterDrug

    Also called Active Comparator

    12.5 mg/hr of bupivacaine was administered continuously via a paraneural catheter for 48 hours following surgery to determine whether superior analgesia was obtained when compared to single shot block with a sham catheter.

  • Single Shot Adductor Canal Saphenous Block with BupivacaineOther

    Also called Sham Comparator

    A sham catheter was placed on the skin and covered in a dressing to blind the patient, data collector and investigator as to group allocation

Study groups in NCT03145584
Study groupRoleWhat they receive
Continuous Adductor Canal Saphenous CatheterActive comparatorParticipants in this group were randomly allocated to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A PERINEURAL CATHETER WAS INSERTED IMMEDIATELY AFTER INJECTION OF THE INITIAL BOLUS OF LOCAL ANAESTHETIC. THE CATHETER WAS CONNECTED TO A PAJUNK FUSERPUMP CONTAINING 350 ML OF 0.15625% BUPIVACAINE AND INFUSED AT 8ML/HR.
Receives: Drug: Continuous Bupivacaine via Adductor Canal Saphenous Catheter
Single Shot Adductor Canal Saphenous BlockSham comparatorParticipants in this group were randomly allocated NOT to receive a perineural catheter placed at the time of adductor canal block (ACB). The ACB was performed under ultrasound guidance and a 10ml injection of 0.5% bupivacaine was administered adjacent to the saphenous nerve. A SHAM CATHETER WAS PLACED ON THE SURFACE OF THE LEG AND COVERED BY AN OPAQUE DRESSING TO CONCEAL THE INSERTION SITE. ALL PATIENTS HAD THE PROXIMAL END OF THEIR CATHETER ATTACHED TO PORTABLE ELASTOMERIC PUMPS (PAJUNK FUSERPUMP 350 ML) CONCEALED IN OPAQUE BAGS TO PREVENT PATIENTS AND ASSESSORS FROM DETERMINING WHICH PUMPS WERE ACTUALLY FUNCTIONING. THESE PUMPS FUNCTION WITHOUT A MOTOR AND SO MAKE NO SOUND.
Receives: Other: Single Shot Adductor Canal Saphenous Block with Bupivacaine

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Degree of active knee flexion

    The degree of active knee flexion was measured during physiotherapy using callipers

    Measured: During the post operative physiotherapy session on Post-operative Day (POD) 2

Secondary outcomes (13)
  1. Numerical rating pain score (NRS)

    NRS was measured at 12 hourly intervals at 8am and 8pm on POD 1 \& 2

    Measured: 8pm on the evening of surgery

  2. Numerical rating pain score (NRS)

    NRS was measured at 12 hourly intervals at 8am and 8pm on POD 1 \& 2

    Measured: 8am POD 1

  3. Numerical rating pain score (NRS)

    NRS was measured at 12 hourly intervals at 8am and 8pm on POD 1 \& 2

    Measured: 8pm POD 1

  4. Numerical rating pain score (NRS)

    NRS was measured at 12 hourly intervals at 8am and 8pm on POD 1 \& 2

    Measured: 8am POD 2

  5. Numerical rating pain score (NRS)

    NRS was measured at 12 hourly intervals at 8am and 8pm on POD 1 \& 2

    Measured: 8pm POD 2

  6. Numerical rating pain score (NRS)

    NRS was measured before physiotherapy

    Measured: Before physiotherapy POD 1

  7. Numerical rating pain score (NRS)

    NRS was measured after physiotherapy

    Measured: After physiotherapy POD 1

  8. Numerical rating pain score (NRS)

    NRS was measured before physiotherapy

    Measured: Before physiotherapy POD 2

  9. Numerical rating pain score (NRS)

    NRS was measured after physiotherapy

    Measured: After physiotherapy POD 2

  10. Degree of active Knee Flexion

    The degree of active Knee flexion was measured using callipers during physiotherapy on POD 1

    Measured: POD 1

  11. Cumulative Oxycodone Consumption

    The quantity of oxycodone consumed over 48 hours was recorded from the patients notes

    Measured: 48 hours

  12. TUG Test

    The timed up and go (TUG) test was completed during physiotherapy

    Measured: POD 1

  13. TUG Test

    The timed up and go (TUG) test was completed during physiotherapy

    Measured: POD 2

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 May 2017
  2. Study startJul 2015
  3. Primary completion20 Dec 2015
  4. Study completion31 Dec 2015

Resources

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
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03145584
Sponsor's protocol ID
ECM 4 ppp 070715
Status last verified
May 2017
First submitted
16 Dec 2016
Last updated
9 May 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Continuous Bupivacaine via Adductor Canal Saphenous Catheter and Single Shot Adductor Canal Saphenous Block with Bupivacaine in people with Pain, Postoperative, run by University College Cork at 1 site in Ireland.

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 3 inclusion and 7 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 9 May 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 Ireland. 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.

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?

Degree of active knee flexion (time frame: During the post operative physiotherapy session on Post-operative Day (POD) 2). 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 9 May 2017.

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