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Arthroplasty, Replacement, KneePhase 4NCT00895531

Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement

A Phase 4 study testing Depodur and sciatic nerve block in people with Arthroplasty, Replacement, Knee, run by University of Louisville at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Arthroplasty, Replacement, Knee
What is being tested?
Depodur and sciatic nerve block
Could I receive a placebo?
No, everyone receives an active treatment
How many people
75 participants
Where
1 siteUnited States
Study dates
Dec 2009to Dec 2012
Phase
Phase 4
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Scheduled for total knee replacement or revision of total knee replacement
  • Agree to have a regional technique including neuraxial analgesia for post-operative analgesia
  • Be 18 to 70 years old
  • Classified as ASA score I-III

Who cannot join

  • Allergic to morphine
  • Allergic to local anesthetics
  • Been on opioids for more than 4 weeks
  • Not willing to be randomized
  • On anticoagulation medications that prevent placement of epidural
  • Sensitive to effects of neuraxial opioids
Show all 20Show fewer
  • BMI>35
  • Severe COPD
  • Obstructive sleep apnea (OSA, see below). Each patient will be asked the questions below to determine their risk for OSA (STOP questionnaire). Patients who answer yes to 3 or more of the major criteria of the STOP questionnaire and have one of the minor criteria will be excluded from the study
  • STOP Questionnaire for OSA
  • Major Criteria:
  • S- Do you snore loudly (louder than talking or loud enough to be heard through closed doors)?
  • T-"Do you often feel tired, fatigued, or sleepy during daytime?
  • O-"Has anyone observed you stop breathing during your sleep?
  • P-"Do you have or are you being treated for high blood pressure?
  • Minor Criteria:
  • BMI>35
  • Age>50 yrs
  • Neck Circumference>40 cm
  • Male gender

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Louisville Hospital

    Louisville, Kentucky, 40202

Other trials in United States

About this study

Official title: Comparison of Peripheral Nerve Blocks vs. Combination of Peripheral Nerve Block and DepoDur in Total Knee Joint Replacement: A Prospective, Randomized Study

The investigators hypothesize that patients who receive a femoral catheter with low dose epidural Depodur will experience comparable or superior pain relief than those who receive both femoral and sciatic catheters. In addition, the investigators hypothesize that the one catheter will be less time consuming to place and facilitate early ambulation of the patient.

Read the detailed description

After obtaining written informed consent, all patients will be sedated with 1-5 mg midazolam and up to 100 mcg fentanyl before any procedure is performed. They will be attached to standard ASA monitors and their vital signs recorded before sedation and every 5 minutes throughout the procedure. They will receive supplemental oxygen 2-4 LPM with a nasal canula. They will be given 1 g acetaminophen orally with a sip of water before sedation.

The randomization envelope will be opened and the patient will be randomized to one of the two groups.

All patients will receive a femoral nerve block after identification of the landmarks or with ultrasound guidance and a femoral catheter will be inserted perineurally. The patients will be placed supine position for the procedure. The femoral artery will be identified either by ultrasound or a hand held Doppler. A point 1 cm lateral to the femoral artery and 1 cm below the inguinal crease is marked. A 5 cm Tuohy needle (Pajunk Medical) will be inserted at a 45° angle at 1.5 mA and 1 Hz. Once a brisk quadriceps twitch is identified, the needle will be positioned accurately so as to establish quadriceps stimulation at ≤ 0.5 mA.

The peripheral nerve catheter will be inserted through the needle. Once the catheter is positioned satisfactorily in the perineural area, it will be tunneled subcutaneously and a sterile dressing will be applied to cover the catheter completely. Ropivacaine (30 mL of 0.5%) will be injected through the catheter after frequent aspirations. The block will be assessed by sensory and motor assessments at 5, 10, 15, and 30 minutes. Sensory testing will be performed on the anterior aspect of the knee (femoral nerve), medial aspect of the knee (obturator nerve) and the lateral aspect of the thigh (lateral femoral cutaneous nerve). The block will be considered complete when no cold discrimination was observed (Score 2), partial when cold discrimination was decreased (score 1), and absent when normal cold discrimination was observed (Score 0). Femoral motor block will also be assessed during the same period by testing knee extension, and will be considered complete when no extension is observed, partial when quadriceps motor force is decreased and absent when normal quadriceps function is observed. Patients with complete sensory block of the femoral and obturator nerves after 15 minutes will be included in the study.

Group I: Peripheral Nerve group: This group will have a sciatic catheter placed either before or after surgery. They will receive a sciatic catheter by subgluteal approach with the use of ultrasound. The ischial tuberosity will be identified with the ultrasound probe and its midpoint marked. A point 3 cm lateral and 4 cm caudad will be marked. Patients will be placed in the lateral position. A 18 G Tuohy needle will be inserted at a 45° angle until a peroneal or tibial twitch is obtained at 1.5 mA. Once the current can be reduced to obtain a twitch less than 0.5 mA, a catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.

Group II: Depodur Group: Preoperatively this group of patients will have an L2-L3 epidural placed while they are in the sitting position before or after femoral catheter placement. They will receive 7.5 mg Depodur via the epidural catheter. All of these patients will receive Singular 10 mg and Claritin 10 mg before the epidural Depodur is placed, as per our protocol of patients receiving EREM.

All patients will receive general anesthesia with fentanyl 2 mcg/kg, ketamine 0.2 mg/kg, and propofol, as needed, for induction of anesthesia. The patients will be paralyzed with succinylcholine, rocuronium, or any other non-depolarizing muscle relaxant of choice of anesthesiologist. Analgesia will be maintained at the discretion of the anesthesiologist overseeing the case. Anesthesia will be maintained with a volatile anesthetic and oxygen or TIVA to maintain BIS between 40 and 50. Vital signs will be recorded every 15 minutes. They will also receive dexamethasone 4 mg, metoclopramide 20 mg IV at induction and ondansetron 4 mg after induction, if they have more than 40% risk of PONV as per their Apfel score.

Patients will be extubated at the end of the case and transferred to PACU. If patients complain of pain, they will receive fentanyl 25-50-mcg increments as per the discretion of PACU nurse to achieve a VRS < 4. Patients may be prescribed a morphine PCA (1 mg morphine with a 6-minute lockout) for postoperative pain relief in the PACU once their pain is stable at VRS<4.

All patients will be prescribed acetaminophen 1000 mg every 6 hours for 3 days after surgery. They will be prescribed metoclopramide 20 mg IV PRN every 6 hours as rescue medication for nausea and/or vomiting for 2 days postoperatively. Patients still nauseous will get Promethazine (Phenergan) 6.25-12.5 mg as second line rescue.

Once the patients are transported to the floor, they will be monitored with continuous pulse-oximetry for the first 48 hours. Other vital signs (Pulse, NIBP and Respiratory Rate) will be monitored every hour for the first 12 hours, every 2 hrs from 12-24 hours, and every 4 hours from 24 to 48 hours (ASA 2009 Guidelines for neuraxial opioids).

Postoperative knee joint rehabilitation will involve continuous passive motion (CPM) of the knee joint twice a day. The physical therapist will be asked to record the VRS on movement and the range of motion after placement of the CPM machine.

Being tested
Depodur, sciatic nerve block
Keywords
Knee Replacement, Total, Morphine

What participants receive

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

  • DepodurDrug

    Also called morphine sulfate extended-release liposome injection

    7.5 mg Depodur via the epidural catheter

  • sciatic nerve blockProcedure or surgery

    Also called Nerve block, sciatic

    The sciatic nerve will be identified at the subgluteal level with ultrasound. A point 3 cm lateral and 4 cm caudad will be marked. Patients will be placed in the lateral position. A 18 G Tuohy needle will be inserted at a 45° angle until a peroneal or tibial twitch is obtained at 1.5 mA. Once the current can be reduced to obtain a twitch less than 0.5 mA, a catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.

Study groups in NCT00895531
Study groupRoleWhat they receive
Peripheral Nerve groupActive comparatorGroup will receive sciatic catheter placed before or after surgery by subgluteal approach with the use of ultrasound. The ischial tuberosity will be identified with the ultrasound probe and its midpoint marked. A catheter will be inserted and placed perineurally. If placed preoperatively, the catheter will be flushed with normal saline or 5% dextrose and will not be dosed until after surgery. After the patient is in the PACU and the surgeons have verified the sciatic nerve function, the sciatic catheter will be dosed with 35 mL 0.25% ropivacaine.
Receives: Procedure: sciatic nerve block
Depodur GroupExperimentalpatients will have an L2-L3 epidural placed while they are in the sitting position before or after femoral catheter placement. They will receive 7.5 mg Depodur via the epidural catheter. All of these patients will receive Singular 10 mg and Claritin 10 mg before the epidural Depodur is placed, as per our protocol of patients receiving EREM.
Receives: Drug: Depodur

What is being measured

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

  1. Postoperative Pain

    Pain as reported on a verbal rating scale ( VRS) (0-10, 0 = no pain, 10 = worse pain imaginable).

    Measured: 48 hours

Timeline

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

  1. First posted8 May 2009 (estimated)
  2. Study startDec 2009
  3. Primary completionDec 2012
  4. Study completionDec 2012

Why it stopped: Investigator left institution

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 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Investigator
Enrolment
75 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00895531
Sponsor's protocol ID
09.0255
Status last verified
Jun 2017
First submitted
7 May 2009
Last updated
27 Jul 2017
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Depodur and sciatic nerve block in people with Arthroplasty, Replacement, Knee, run by University of Louisville 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 4 inclusion and 20 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: stopped early, as of the sponsor's last update on 27 Jul 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.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 27 Jul 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?

Postoperative Pain (time frame: 48 hours). 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 27 Jul 2017.

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