Ignite Creation Date:
2024-05-06 @ 12:00 PM
Last Modification Date:
2024-10-26 @ 12:52 PM
Study NCT ID:
NCT03650504
Status:
UNKNOWN
Last Update Posted:
2018-08-28
First Post:
2018-08-22
Brief Title:
Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks
Sponsor:
University of California San Diego
Organization:
University of California San Diego
Study Overview
Official Title:
Effects of Catheter Location Relative to Femoral Artery on Postoperative Analgesia for Continuous Adductor Canal Blocks
Status:
UNKNOWN
Status Verified Date:
2018-08
Last Known Status:
NOT_YET_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Adductor canal AC nerve block is a commonly used modality for postoperative pain control after total knee arthroplasty TKA When the adductor canal is viewed by ultrasound the femoral artery and femoral vein can easily be identified however the nerve that is to be blocked is often not visible For this reason the femoral artery is used as a landmark for the block There currently are no studies examining the optimal placement of the nerve block catheter relative to the femoral artery in the canal The goal of this study will be to examine the relationship between nerve catheter tip location relative to femoral artery within the adductor canal for continuous AC nerve blocks The investigators specifically will compare postoperative pain as well as incidence of vascular puncture during the procedure and time to complete the procedure for two different catheter locations
Detailed Description:
This will be a single-center randomized controlled investigation Consenting adults undergoing unilateral total knee arthroplasty with a planned adductor canal perineural catheter will be offered enrollment Study inclusion will be proposed to eligible patients prior to surgery If a patient desires study participation written informed consent will be obtained using a current UCSD IRB-approved ICF Selection for inclusion will not be based on gender race or socioeconomic status
Following written informed consent we will record baseline anthropomorphic information All subjects will have a peripheral intravenous IV catheter inserted standard noninvasive monitors applied supplemental oxygen administered via a nasal cannula or face mask and positioned supine Midazolam and fentanyl will be titrated for patient comfort while ensuring that patients remain responsive to verbal cues The ultrasound will be placed to visualize the short axis cross-section of the adductor canal If both sites above femoral artery versus between femoral artery and vein are acceptable for catheter insertion the subject will be randomized using a computer-generated list blocks of 8 to one of two treatment groups in a 11 ratio using sealed opaque consecutively numbered envelopes 1 above femoral artery vs 2 between femoral artery and vein
Catheter insertion will adhere to current UCSD standard-of-care The only difference for subjects participating in the study will be that the specific catheter insertion location will be determined randomly instead of the physician simply choosing himherself All catheters will be placed by a regional anesthesia fellow under the direct supervision and guidance of a regional anesthesia attending All catheters will be placed using standard UCSD perineural catheter techniques
The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol and a clear sterile fenestrated drape applied The ultrasound probe will be placed to visualize the short-axis cross-section of the target nerves A 17-gauge needle FlexTip Teleflex Medical Triangle Research Park NC USA will be used to place all perineural catheters The catheter-placement needle will be inserted through the skin wheal advanced in-plane beneath the US transducer and directed to the target nerve as described below
Above-the-artery The needle will be directed below the nerve to about five oclock of the artery The needle will then be advanced to twelve oclock of the artery while opening the adductor canal space with saline until adequate opening of the canal is realized At that point the catheter is placed above the artery
Between-the-artery-and-vein The needle will be directed above the nerve and placed at one oclock of the artery Then the needle will be positioned at about six oclock of the artery and advanced between the femoral artery and vein with simultaneous pressure until the adductor canal opens appropriately The perineural catheter will be placed between the artery and vein
Saline 10 mL will be administered via the needle to dilate the space where the catheter is to be inserted A flexible non-stimulating perineural catheter will be inserted 3-5 cm past the needle tip and the needle withdrawn over the catheter A 30 mL bolus of lidocaine 2 with 1400000 of epinephrine will then be administered through the catheter
Intraoperatively patients may receive a general andor neuraxial anesthetic that would be determined by the intraoperative anesthesia provider Additional boluses of 10 mL 2 lidocaine with epinephrine may be given if needed via the perineural catheter
Perineural infusion An infusion pump will be attached to each subjects perineural catheter The pump will provide ropivacaine 02 at 6 mLh and a 4 mL patient-controlled bolus with a 30-minute lockout
Data collection All data collection will be through standard UCSD nursingtherapy electronic medical record notes for the day following surgery
Primary endpoint The primary endpoint will be the average pain on post operative day 1 following surgery as measured on a numeric rating scale 0-10 0no pain 10worst imaginable pain during the time periods of 0800-2400
Secondary endpoints Other data collected will include 1 total procedure duration from needle-in to needle-out 2 total opioid consumption on postoperative day 1 3 worst pain score measured on a numeric rating scale 4 number of intra-procedural vascular punctures 5 total local anesthetic infused in 24 hours following surgery and 6 distance ambulated on postoperative day 1 with first session of physical therapy
Sample size estimates
The primary analysis will utilize the Wilcoxon Rank Sum test The mean postoperative day 1 pain scores following adductor canal catheter placement for total knee arthroplasty is 412 with standard deviation 1742 The null hypothesis is that the above-the-artery group is inferior to the between-the-artery-and-vein group The alternative hypothesis is that the above-the-artery group in non-inferior to the between-the-artery-and-vein group Assuming a non-inferiority limit of 15 power 080 two-side alpha 005 we will require 17 patients in each group total 34 To account for dropouts we plan to recruit 20 patients in each group totaling 40 patients all together
Following written informed consent we will record baseline anthropomorphic information All subjects will have a peripheral intravenous IV catheter inserted standard noninvasive monitors applied supplemental oxygen administered via a nasal cannula or face mask and positioned supine Midazolam and fentanyl will be titrated for patient comfort while ensuring that patients remain responsive to verbal cues The ultrasound will be placed to visualize the short axis cross-section of the adductor canal If both sites above femoral artery versus between femoral artery and vein are acceptable for catheter insertion the subject will be randomized using a computer-generated list blocks of 8 to one of two treatment groups in a 11 ratio using sealed opaque consecutively numbered envelopes 1 above femoral artery vs 2 between femoral artery and vein
Catheter insertion will adhere to current UCSD standard-of-care The only difference for subjects participating in the study will be that the specific catheter insertion location will be determined randomly instead of the physician simply choosing himherself All catheters will be placed by a regional anesthesia fellow under the direct supervision and guidance of a regional anesthesia attending All catheters will be placed using standard UCSD perineural catheter techniques
The area of insertion will be cleaned with chlorhexidine gluconate and isopropyl alcohol and a clear sterile fenestrated drape applied The ultrasound probe will be placed to visualize the short-axis cross-section of the target nerves A 17-gauge needle FlexTip Teleflex Medical Triangle Research Park NC USA will be used to place all perineural catheters The catheter-placement needle will be inserted through the skin wheal advanced in-plane beneath the US transducer and directed to the target nerve as described below
Above-the-artery The needle will be directed below the nerve to about five oclock of the artery The needle will then be advanced to twelve oclock of the artery while opening the adductor canal space with saline until adequate opening of the canal is realized At that point the catheter is placed above the artery
Between-the-artery-and-vein The needle will be directed above the nerve and placed at one oclock of the artery Then the needle will be positioned at about six oclock of the artery and advanced between the femoral artery and vein with simultaneous pressure until the adductor canal opens appropriately The perineural catheter will be placed between the artery and vein
Saline 10 mL will be administered via the needle to dilate the space where the catheter is to be inserted A flexible non-stimulating perineural catheter will be inserted 3-5 cm past the needle tip and the needle withdrawn over the catheter A 30 mL bolus of lidocaine 2 with 1400000 of epinephrine will then be administered through the catheter
Intraoperatively patients may receive a general andor neuraxial anesthetic that would be determined by the intraoperative anesthesia provider Additional boluses of 10 mL 2 lidocaine with epinephrine may be given if needed via the perineural catheter
Perineural infusion An infusion pump will be attached to each subjects perineural catheter The pump will provide ropivacaine 02 at 6 mLh and a 4 mL patient-controlled bolus with a 30-minute lockout
Data collection All data collection will be through standard UCSD nursingtherapy electronic medical record notes for the day following surgery
Primary endpoint The primary endpoint will be the average pain on post operative day 1 following surgery as measured on a numeric rating scale 0-10 0no pain 10worst imaginable pain during the time periods of 0800-2400
Secondary endpoints Other data collected will include 1 total procedure duration from needle-in to needle-out 2 total opioid consumption on postoperative day 1 3 worst pain score measured on a numeric rating scale 4 number of intra-procedural vascular punctures 5 total local anesthetic infused in 24 hours following surgery and 6 distance ambulated on postoperative day 1 with first session of physical therapy
Sample size estimates
The primary analysis will utilize the Wilcoxon Rank Sum test The mean postoperative day 1 pain scores following adductor canal catheter placement for total knee arthroplasty is 412 with standard deviation 1742 The null hypothesis is that the above-the-artery group is inferior to the between-the-artery-and-vein group The alternative hypothesis is that the above-the-artery group in non-inferior to the between-the-artery-and-vein group Assuming a non-inferiority limit of 15 power 080 two-side alpha 005 we will require 17 patients in each group total 34 To account for dropouts we plan to recruit 20 patients in each group totaling 40 patients all together
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None