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Orthopedic Surgery of Lower ExtremityNCT01167907

Evaluation of Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block After Ankle Surgery

A study testing 0.2% ropivacaine and saline in people with Orthopedic Surgery of Lower Extremity, run by Wake Forest University Health Sciences at 1 site in United States.

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

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Orthopedic Surgery of Lower Extremity
What is being tested?
0.2% ropivacaine and saline
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
32 participants
Where
1 siteUnited States
Study dates
Jul 2010to 7 Sep 2017
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • surgery for unilateral ankle arthrodesis
  • surgery for open reduction and internal fixation of bi/tri malleolar fracture

Who cannot join

  • coagulation abnormalities
  • history of opioid addiction
  • current chronic pain therapy with high dsoe opioid
  • allergy to study medication
  • failure of the sciatic nerve catheter

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Wake Forest University Baptist Medical Center

    Winston-Salem, North Carolina, 27157

Other trials in United States

About this study

Official title: Evaluation of a Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block for Postoperative Analgesia Following Ankle Surgery

A nerve block catheter is a small tube placed next to a nerve through a needle, and the needle is then removed. Numbing medicine is dripped through the tube to reduce pain sensation from the nerve.

The purpose of this research study is to test whether the placement of a second nerve block catheter, rather than a single injection for the saphenous nerve block will improve pain relief and/or reduce pain medication needed after surgery enough to justify two nerve block catheters.

There are two nerves that carry pain sensations from the ankle, the large (sciatic) nerve and the smaller (saphenous) nerve. Patients undergoing ankle fusion or fracture surgery at Wake Forest University typically have a nerve block catheter placed next to the sciatic nerve to give local anesthetic (numbing medicine) for 24-72 hours. In addition, a single injection of local anesthetic is usually performed to block the saphenous nerve for 12-16 hours postoperatively.

Read the detailed description

Interventions and Interactions Study participants will be asked to report a preoperative baseline pain score (Numeric Pain Scale (0-10)), and have quadriceps strength measured (see below) prior to any sedation being administered. Patients will undergo placement of a continuous subgluteal sciatic nerve catheter, and dosage with 25ml of 0.25% bupivacaine with epinephrine 1:200,000 and clonidine 25 mcg per usual technique after sedation. A perineural catheter will then be placed for primary saphenous nerve block and postoperative saphenous infusion. This continuous saphenous catheter will be placed using ultrasound guidance (Sonosite Turbo ™, Bothell, WA) (6-13MHz linear probe). The superficial femoral artery will be identified in short axis at approximately the midpoint or distal third of the femur as the artery lies deep to the sartorius muscle in the adductor canal. Using aseptic technique, an 18 gauge tuohy needle will be inserted in-plane from lateral to the transducer and advanced to a position anteromedial to the artery, between sartorius and vastus medialis muscles. Proper positioning will be confirmed by injection of saline, a 20g multiorifice catheter will be inserted 3-4 cm beyond the needle tip and the catheter will be tunneled and taped up the medial surface of the thigh. The catheter will be test dosed with 1.5% lidocaine with 1:200,000epinephrine to confirm position and rule out IV injection. The primary saphenous nerve block will be produced by incremental injection through the catheter of 10ml of 0.25% bupivacaine with epinephrine 1:200,000 and clonidine 15 mcg. Successful saphenous block will be defined as loss of sensation to pinprick in the mid, anteromedial leg measured at 15 and 30 minutes post-block. A 3-point scale will be used to define sensory block: 0=full sensation, 1= touch without sharp sensation, 2=absent sensation.

To determine the effect of saphenous block on quadriceps function, patients will have knee extension muscle strength tested pre-block and 30 min post-block using a Hoggan Health microFET 2 MT Digital Handheld Dynamometer. After placement of both the saphenous and sciatic nerve catheters, patients will receive either neuraxial or general anesthesia for surgical anesthesia at the discretion of the attending anesthesiologist medically directing their primary anesthetic technique.

Patients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement. The randomization will occur by sealed envelope provided to the OR Pharmacy (block randomization in blocks of 10) and the OR pharmacy will prepare the 300 ml elastomeric pump with active or control solution. The On-Q C-Bloc™(300ml capacity) (I-Flow corporation) pump will be attached to the saphenous catheter in the PACU, or within 6h of primary block; the catheter will infuse for 60 hours.

The patients, physicians, nurses and investigators will be blinded to treatment group.

The sciatic infusion will be managed per usual practice: postoperatively all patients will receive 0.2% ropivacaine through their sciatic nerve catheter at a basal infusion rate of 10ml/h, . The sciatic pump will be an On-Q™ pump per usual practice. All patients will have oral and IV opioids prescribed while hospitalized, and oral opioids prescribed after hospital discharge. In the event of breakthrough pain, patients will be instructed to adjust the sciatic nerve pump, and/or to take oral opioids for the pain.

While patients are hospitalized, opioid administration and pain scores will be recorded by nursing staff on the patient care record. Side effects including nausea, vomiting, or itching will also be recorded. Patients will be seen on a daily basis while in the hospital by the acute pain service, and adjustment of their sciatic infusion performed if indicated. They will be questioned about sleep quality, pain score, opioid side effects, and sensory function in the sciatic and saphenous distributions. This information will be recorded by the acute pain management team. On postoperative day 1, all patients will again have their quadriceps muscle group strength assessed with the hand-held dynamometer, and the catheter sites will be inspected per standard protocol.

Patients will be generally discharged home with peripheral nerve catheters in place on POD #1, after receiving written and verbal instructions in perineural catheter management. These patients will be called at 24 and 48 hours post discharge to determine rest and incident numeric pain scores, opioid usage, sleep quality (as number of awakenings for pain), and the presence of nausea or vomiting. Patients will be given contact numbers and instructions to call with any questions or concerns per usual practice.

Outcome Measure(s) The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved. Secondary endpoints of reduction of opioid use, nausea and vomiting, sleep disturbance (as number of awakenings), and reduction of quadriceps strength will also be evaluated.

Being tested
0.2% ropivacaine, saline
Keywords
ankle, arthrodesis, internal fixation, bi/tri malleolar fracture
Medical subject headings
Ankylosis

What participants receive

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

  • 0.2% ropivacaineDevice

    Also called NAROPIN®

    0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

  • salineDrug

    saline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement

Study groups in NCT01167907
Study groupRoleWhat they receive
0.2% ropivacaineExperimentalPatients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
Receives: Device: 0.2% ropivacaine; Drug: saline
SalinePlacebo comparatorPatients with evidence of sciatic and saphenous nerve block will be randomized to receive a postoperative continuous infusion of either saline (control) or 0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement.
Receives: Drug: saline

What is being measured

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

  1. Verbal Pain Scores

    The primary endpoint of this study will be a reduction of the rest and incident verbal pain scores 48hpost-nerve blockade when the primary saphenous single-shot block is expected to have resolved.

    "Verbal Pain Score" is the outcome measure applied by asking patients to rate their level of pain. The commonly used 11-point numerical pain rating, with 0-10 range is defined as the following: Zero (0) is used to rate "no pain" and is the best score Ten (10) is used to rate "the worst pain imaginable" and is the worst score

    Measured: 48 hours post nerve blockade

Secondary outcomes (5)
  1. Opioid Use

    Secondary endpoints of reduction of opioid use will be evaluated.

    Outcome will be measured using 24h mg-equivalent oxycodone consumption. - (Units in mg/24h)

    Measured: 48 hours post nerve blockade

  2. Nausea

    Secondary endpoints of reduction of nausea will be evaluated.

    Measured: 48 hours post nerve blockade

  3. Vomiting

    Secondary endpoints of reduction of vomiting will be evaluated.

    Measured: 48 hour post nerve blockade

  4. Sleep Disturbance

    Secondary endpoints of reduction of sleep disturbance (as number of awakenings) will be evaluated.

    Measured: 48 hours post nerve blockade

  5. Reduction of Quadriceps Strength

    Secondary endpoints of reduction of quadriceps strength will be evaluated. To determine the effect of saphenous block on quadriceps function, patients will have knee extension muscle strength using a Hoggan Health microFET 2 MT Digital Handheld Dynamometer.

    Knee Extension: Measuring knee extension was performed with the digital dynamometer placed on the anterior surface of the lower leg proximal to the ankle.

    Measured: 24 hours post nerve blockade

Timeline

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

  1. First posted22 Jul 2010 (estimated)
  2. Study startJul 2010
  3. Primary completion7 Sep 2017
  4. Study completion7 Sep 2017

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
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
32 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01167907
Sponsor's protocol ID
IRB00013823
Status last verified
Jul 2018
First submitted
21 Jul 2010
Last updated
31 Aug 2018
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes

Questions about this trial

What is this clinical trial studying?

A study testing 0.2% ropivacaine and saline in people with Orthopedic Surgery of Lower Extremity, run by Wake Forest University Health Sciences 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 2 inclusion and 5 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 31 Aug 2018. 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. 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?

Yes. Results are posted in the registry (first posted 8 Dec 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Verbal Pain Scores (time frame: 48 hours post nerve blockade). 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 31 Aug 2018.

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