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.
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
- Type of treatment
- Injection or infusion, Medical device
- 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
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.
- Conditions
- Orthopedic Surgery of Lower Extremity
- 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 group | Role | What they receive |
|---|---|---|
| 0.2% ropivacaine | Experimental | 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. Receives: Device: 0.2% ropivacaine; Drug: saline |
| Saline | Placebo comparator | 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. Receives: Drug: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
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
Nausea
Secondary endpoints of reduction of nausea will be evaluated.
Measured: 48 hours post nerve blockade
Vomiting
Secondary endpoints of reduction of vomiting will be evaluated.
Measured: 48 hour post nerve blockade
Sleep Disturbance
Secondary endpoints of reduction of sleep disturbance (as number of awakenings) will be evaluated.
Measured: 48 hours post nerve blockade
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.
- First posted22 Jul 2010 (estimated)
- Study startJul 2010
- Primary completion7 Sep 2017
- Study completion7 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Orthopedic Surgery of Lower ExtremityStudies of the same condition, open and under way.
- More trials run by Wake Forest University Health SciencesThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Wake Forest University Health Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- I-Flow
- Responsible party
- Sponsor
- Investigators
- Robert Weller, M.D., Principal investigator, Wake Forest Univesity Health Sciences
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
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a Continuous Saphenous Nerve Block to Supplement a Continuous Sciatic Nerve Block for Postoperative Analgesia Following Ankle Surgery
- ClinicalTrials.gov ID
- NCT01167907
- Acronym / sponsor ID
- IRB00013823
- Conditions
- Orthopedic Surgery of Lower Extremity
- Keywords
- ankle, arthrodesis, internal fixation, bi/tri malleolar fracture
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Wake Forest University Health SciencesUniversity, hospital or other
- Collaborators
- I-Flow
- Study start
- Jul 2010
- Primary completion
- 7 Sep 2017 (actual)
- Study completion
- 7 Sep 2017 (actual)
- First posted
- 22 Jul 2010 (estimated)
- Results
- Posted 8 Dec 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 0.2% ropivacaine | Experimental | Device: 0.2% ropivacaine, Drug: salinePatients 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. |
| Saline | Placebo comparator | Drug: salinePatients 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- surgery for unilateral ankle arthrodesis
- surgery for open reduction and internal fixation of bi/tri malleolar fracture
Key exclusion criteria (5 listed)
- coagulation abnormalities
- history of opioid addiction
- current chronic pain therapy with high dsoe opioid
- allergy to study medication
- failure of the sciatic nerve catheter
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 |
|---|---|---|
| 0.2% ropivacaineAlso: NAROPIN®0.2% ropivacaine by elastomeric infusion pump at 5ml/h started within 6h of catheter placement | Device | 0.2% ropivacaine |
| salinesaline (control) by elastomeric infusion pump at 5ml/h started within 6h of catheter placement | Drug | 0.2% ropivacaine, Saline |
Primary outcome
Verbal Pain Scores
Time frame: 48 hours post nerve blockade
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
5 secondary outcomes
Opioid Use
Time frame: 48 hours post nerve blockade
Nausea
Time frame: 48 hours post nerve blockade
Vomiting
Time frame: 48 hour post nerve blockade
Sleep Disturbance
Time frame: 48 hours post nerve blockade
Reduction of Quadriceps Strength
Time frame: 24 hours post nerve blockade
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
Robert Weller, M.D. principal investigator
Wake Forest Univesity Health Sciences
1 site in 1 country: see every site and its status.
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.