Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02523235
Recruitment Status : Completed
First Posted : August 14, 2015
Results First Posted : September 3, 2019
Last Update Posted : September 3, 2019
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:
Currently, continuous adductor canal and popliteal-sciatic nerve blocks are used commonly for lower extremity post-operative pain control, specifically for total knee arthroplasty and foot/ankle surgery, respectively. A perineural catheter used to infuse local anesthetic for postoperative analgesia may be placed at various locations along the target nerves. Investigations of single-injection peripheral nerve blocks suggest that the onset of the block might be faster with one location over the other; but, the success rates are equivalent. However, remaining unknown is whether there is an optimal location to place a perineural catheter as part of a continuous peripheral nerve block.

Condition or disease Intervention/treatment Phase
Post-surgical Pain Total Knee Arthroplasty Foot/Ankle Surgery Catheterization for Postop Analgesia Drug: ropivacaine 0.2% Phase 4

Show Show detailed description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 117 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: Effects of Catheter Location on Postoperative Analgesia for Continuous Adductor Canal and Popliteal-Sciatic Nerve Blocks
Actual Study Start Date : August 2015
Actual Primary Completion Date : February 2018
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: proximal catheter insertion

Adductor canal catheters: Inserted as described by Jæger et al., 2013: "…we performed an ultrasound survey at the medial part of the thigh, halfway between the superior anterior iliac spine and the [superior border of the] patella. In a short axis view, we identified the femoral artery underneath the sartorius muscle, with the vein just inferior and the saphenous nerve just lateral to the artery."

Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle will be inserted to intersect the sciatic nerve 6-7 cm proximal to the mark on the skin (therefore, proximal to the sciatic bifurcation) and injection with saline used to ensure subepimyseal spread.

Drug: ropivacaine 0.2%
Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout

Experimental: distal catheter insertion

Adductor canal catheters: Inserted as described by Manickam et al. 2009

Popliteal catheters: Using an ultrasound, the bifurcation of the sciatic nerve will be identified in short axis and marked at a point immediately distal at which point the two main branches of the sciatic nerve are separate and a hypoechoic area can be viewed between the two. This level will be marked on the skin. The needle tip will be inserted into the hypoechoic area between the two branches of the sciatic nerve immediately distal to the sciatic nerve bifurcation between the paraneurium and epineurium (the subparaneural space/compartment). As described by Tran et al, "An adequate position was defined as the presence of circular expansion of the paraneural sheath... Once circular expansion was obtained, we injected."

Drug: ropivacaine 0.2%
Perineural ropivacaine 0.2% at 8 mL/h (adductor) or 6 mL/h (popliteal) basal rate infusion and a 4 mL patient-controlled bolus with a 30 minute lockout




Primary Outcome Measures :
  1. Pain (Average): Numeric Rating Scale for Pain [ Time Frame: Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal) ]
    Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)


Secondary Outcome Measures :
  1. Pain (Worst) :Numeric Rating Scale for Pain [ Time Frame: Average for the day after surgery 08:00-24:00 (adductor) and the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal) ]
    Numeric Rating Scale for Pain (0-10; 0=no pain and 10=worst imaginable pain)

  2. Analgesic Use: IV Morphine Equivalents [ Time Frame: Average for Intraoperative, in the recovery room, after the recovery room until 08:00 day after surgery, and 08:00-24:00 day after surgery ]
    IV morphine equivalents

  3. Ambulation: Distance in Meters [ Time Frame: Average for morning and afternoon following surgery ]
    distance in meters

  4. Pain During Afternoon Physical Therapy Session [ Time Frame: Average during physical therapy in the afternoon following surgery ]
    Pain during afternoon physical therapy session as measured with the Numeric Rating Scale (0-10; 0=no pain and 10=worst imaginable pain)

  5. Number of Participants That Had Fluid Leakage Reported at Catheter Site. [ Time Frame: From surgery through the day after surgery ]
    If subjects detected leakage at the catheter site, the response was recorded as "yes"; and, if subjects did not detect leakage at the catheter site, the response was recorded as "no".

  6. Toe/Foot Numbness (Insensate) :0-10 Scale [ Time Frame: Average for the morning after surgery for 2 hours before phone call made between 10:00-noon (popliteal only) ]
    0-10 scale, 0=no numbness and 10=completely insensate

  7. Total Local Anesthetic Infused (Adductor Only) : mL [ Time Frame: The day following surgery recorded during mid-day rounds ]
    mL



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. undergoing surgery with an adductor canal or popliteal-sciatic perineural catheter for postoperative analgesia following primary tri-compartment knee arthroplasty or foot/ankle surgery;
  2. anticipated to have at least moderate pain following surgery [NRS>3]; and,
  3. age 18 years or older.

Exclusion Criteria:

  1. pregnancy (a urine pregnancy test is standard at UCSD for female patients prior to menopause who are sexually active with the opposite sex within the previous year);
  2. inability to communicate with the investigators and hospital staff;
  3. clinical neuropathy in the surgical extremity;
  4. chronic high-dose opioid use (defined as daily use for more than 4 weeks prior to surgery of at least the equivalent of 20 mg oxycodone);
  5. BMI > 40 kg/m2;
  6. allergy to study medications (lidocaine, ropivicaine);
  7. known renal insufficiency; or,
  8. incarceration.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02523235


Locations
Layout table for location information
United States, California
University California San Diego
San Diego, California, United States, 92103-8770
Sponsors and Collaborators
University of California, San Diego
  Study Documents (Full-Text)

Documents provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT02523235    
Other Study ID Numbers: Prox-Distal Catheter Insertion
First Posted: August 14, 2015    Key Record Dates
Results First Posted: September 3, 2019
Last Update Posted: September 3, 2019
Last Verified: August 2019
Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
moderate pain
severe pain
surgery
postop analgesia
TKA
adductor catheter
poplital catheter
foot/ankle surgery
Additional relevant MeSH terms:
Layout table for MeSH terms
Agnosia
Perceptual Disorders
Neurobehavioral Manifestations
Neurologic Manifestations
Nervous System Diseases
Ropivacaine
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents