Ignite Creation Date:
2024-05-05 @ 7:12 PM
Last Modification Date:
2024-10-26 @ 9:45 AM
Study NCT ID:
NCT00620828
Status:
COMPLETED
Last Update Posted:
2015-06-03
First Post:
2008-02-12
Brief Title:
The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty
Sponsor:
Duke University
Organization:
Duke University
Study Overview
Official Title:
The Role of Intra-Operative Intracapsular Blocks in Post-Operative Pain Management Following Total Knee Arthroplasty A Double-Blinded Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2013-03
Last Known Status:
None
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:
The purpose of this study is to use a new combination of anesthesia techniques in an attempt to minimize early pain after surgery and improve the patients ability to participate more fully with physical therapy Total knee replacement patients who participate will receive the standard anesthesia This includes a spinal nerve block as well as a femoral nerve block The study is looking at the added benefits of including an injection of numbing medication Bupivicaine to the back of the knee This injection occurs during surgery In order to compare the outcomes we will also have a group of patients who will receive a saline injection as opposed to the numbing medication Patients are randomly assigned to a group Outcomes are measured up until twenty-four hours following the surgery
Detailed Description:
Research Summary
Purpose of Study This prospective randomized blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty TKA with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 05 in conjunction with a continuous femoral nerve catheter
We believe the results of this study will show an improvement in pain control and physical therapy outcomes compared to traditional methods of analgesia in post-op total knee arthroplasty To the best of our knowledge there are no studies in the literature using this combination of femoral nerve analgesia and posterior capsular injection
Certainly regional anesthesia methods such as femoral nerve blocks used alone or in conjunction with sciatic nerve blocks have improved patient pain outcome measures in total knee arthroplasty Several studies have shown a beneficial effect of intra-articular analgesia after capsular closure We believe our study design will combine the beneficial effects of the aforementioned methods and ultimately improve patient pain therapy effort and safety through less narcotic use
Our goal is to share these results in a peer-reviewed journal and at national orthopaedic or anesthesia meetings The data collected will ideally improve care and safety in the post-operative total knee arthroplasty patient
Background and Significance Post-operative pain control in total knee arthroplasty is an area of great study in the orthopaedic surgery and anesthesia literature The use of spinalepidural alone or in combination with regional anesthesia is well studied in the recent literature These techniques have significantly improved patient pain management physicaloccupational therapy outcomes and shortened time to discharge
Additionally intra-articular injection of local anesthetic after capsular closure has been studied recently Several studies have demonstrated a beneficial effect of intra-articular local anesthetic on pain outcome measures 6 8 9 10 15 Although other studies have reported more equivocal results The impact of capsular analgesia has on post-operative pain is intriguing Decreased afferent pain perception by the capsular nerves from local anesthetic may improve outcomes especially in sensory distributions where regional anesthesia is inadequate or not performed
Much study has centered on regional anesthesia specifically the use of single shot or continuous femoral nerve blockade 4 5 11 14 16 Such studies have demonstrated a statistically significant decrease in total narcotic use sedation scores and visual analog pain scores Femoral nerve blockade is now an accepted method of post-op pain control in the total knee arthroplasty patient
Further investigation has centered on the addition of sciatic nerve blockade to femoral nerve block 1-3 7 12 13 Several studies demonstrate a further improvement in pain outcomes compared to isolated femoral nerve anesthesia Sciatic nerve blocks can slow physical therapy efforts secondary to a dense motor blockade Equivocal results have been reported in other studies due to this motor block however the sensory component appears to provide improved pain outcome measures
Femoral nerve blockade is a well-accepted modality for analgesia in total knee arthroplasty However femoral nerve block alone does not provide adequate anesthesia to the posterior aspect of the knee We believe that intra-operative injection of ropivicaine 05 into the posterior capsule will provide analgesia analogous to the sensory component of a sciatic nerve block while eliminating the limiting effects of the motor blockade The combination of femoral nerve block and intra-operative posterior capsular injection will ideally yield improved pain management and physical therapy efforts above a baseline femoral nerve block
Design and procedures This is a prospective double-blinded randomized trial consisting of two study groups posterior capsular saline injection control and the experimental posterior capsular ropivicaine 05 injection group All patients will receive spinal anesthesia and a continuous femoral nerve block Each group will include 45 patients n 90 patients
All patients will have an elective primary total knee arthroplasty performed No revision or bilateral cases will be included Exclusion criteria will include patients with a known allergy to ropivicaine or fentanyl a known history of narcotic abuse or chronic pain a known diagnosis of peripheral neuropathy or complex regional pain syndrome or a significant impediment to physical therapy participation
Following the informed consent process patients will receive a continuous femoral nerve block via catheter placed by experienced regional anesthesiologists at our institution Each patient will also receive spinal anesthesia for intra-operative pain control A standard midline skin incision with medial para-patellar arthrotomy will be performed followed by implantation of either a Next Gen ZimmerWarsaw IN or Natural Knee II Zimmer Warsaw IN or Posterior Femoral Component PFC Sigma DePuy Warsaw IN system Prior to surgery patients will be randomized to the saline or ropivicaine groups Both groups will receive their respective injection prior to implantation of the components
The posterior capsule of the knee will be divided in to four quadrants each receiving a saline or ropivicaine injection per randomization Safety measures will include standard pre-injection aspiration to check for vascular blush and intra-operative Doppler ultrasound to identify vascular structures in the posterior knee Additionally the anesthesiologist will not be blinded as heshe will be responsible for assuring the appropriate medication is used and will be closely monitoring for cardiac arrhythmias in the unlikely event that an intravascular injection occurs Post-operatively a standard bulky dressing will be applied All patients will be weight bearing as tolerated post-operative day 1 A fentanyl PCA will be initiated in the PACU and will be continued until post-operative day 2 Dosing will be calculated based on lean body mass Continuous femoral nerve blockade will continue until post-operative day 2 as well
Outcomes will include total PCA narcotic use visual analog pain scale with a diagram to localize pain and Ramsey sedation scores This data will be collected at the following intervals in the PACU 4 8 12 and 24 hours post-operatively We will also measure post-operative day 1 knee range of motion total ambulation distance and time to straight leg raise A standard Institutional Review Board IRB approved data collection sheet will be utilized
We hypothesize that total post-operative narcotic use visual analog pain scores and Ramsey sedation scores will be significantly lower in the study group posterior capsular ropivicaine 05 injection Additionally we anticipate the knee range of motion total ambulation distance and time to straight leg raise to be significantly improved as well
Purpose of Study This prospective randomized blinded controlled trial will be conducted to evaluate post-operative pain control and physical therapy outcomes in primary total knee arthroplasty TKA with the use of spinal analgesia and intra-operative posterior capsular injections of ropivicaine 05 in conjunction with a continuous femoral nerve catheter
We believe the results of this study will show an improvement in pain control and physical therapy outcomes compared to traditional methods of analgesia in post-op total knee arthroplasty To the best of our knowledge there are no studies in the literature using this combination of femoral nerve analgesia and posterior capsular injection
Certainly regional anesthesia methods such as femoral nerve blocks used alone or in conjunction with sciatic nerve blocks have improved patient pain outcome measures in total knee arthroplasty Several studies have shown a beneficial effect of intra-articular analgesia after capsular closure We believe our study design will combine the beneficial effects of the aforementioned methods and ultimately improve patient pain therapy effort and safety through less narcotic use
Our goal is to share these results in a peer-reviewed journal and at national orthopaedic or anesthesia meetings The data collected will ideally improve care and safety in the post-operative total knee arthroplasty patient
Background and Significance Post-operative pain control in total knee arthroplasty is an area of great study in the orthopaedic surgery and anesthesia literature The use of spinalepidural alone or in combination with regional anesthesia is well studied in the recent literature These techniques have significantly improved patient pain management physicaloccupational therapy outcomes and shortened time to discharge
Additionally intra-articular injection of local anesthetic after capsular closure has been studied recently Several studies have demonstrated a beneficial effect of intra-articular local anesthetic on pain outcome measures 6 8 9 10 15 Although other studies have reported more equivocal results The impact of capsular analgesia has on post-operative pain is intriguing Decreased afferent pain perception by the capsular nerves from local anesthetic may improve outcomes especially in sensory distributions where regional anesthesia is inadequate or not performed
Much study has centered on regional anesthesia specifically the use of single shot or continuous femoral nerve blockade 4 5 11 14 16 Such studies have demonstrated a statistically significant decrease in total narcotic use sedation scores and visual analog pain scores Femoral nerve blockade is now an accepted method of post-op pain control in the total knee arthroplasty patient
Further investigation has centered on the addition of sciatic nerve blockade to femoral nerve block 1-3 7 12 13 Several studies demonstrate a further improvement in pain outcomes compared to isolated femoral nerve anesthesia Sciatic nerve blocks can slow physical therapy efforts secondary to a dense motor blockade Equivocal results have been reported in other studies due to this motor block however the sensory component appears to provide improved pain outcome measures
Femoral nerve blockade is a well-accepted modality for analgesia in total knee arthroplasty However femoral nerve block alone does not provide adequate anesthesia to the posterior aspect of the knee We believe that intra-operative injection of ropivicaine 05 into the posterior capsule will provide analgesia analogous to the sensory component of a sciatic nerve block while eliminating the limiting effects of the motor blockade The combination of femoral nerve block and intra-operative posterior capsular injection will ideally yield improved pain management and physical therapy efforts above a baseline femoral nerve block
Design and procedures This is a prospective double-blinded randomized trial consisting of two study groups posterior capsular saline injection control and the experimental posterior capsular ropivicaine 05 injection group All patients will receive spinal anesthesia and a continuous femoral nerve block Each group will include 45 patients n 90 patients
All patients will have an elective primary total knee arthroplasty performed No revision or bilateral cases will be included Exclusion criteria will include patients with a known allergy to ropivicaine or fentanyl a known history of narcotic abuse or chronic pain a known diagnosis of peripheral neuropathy or complex regional pain syndrome or a significant impediment to physical therapy participation
Following the informed consent process patients will receive a continuous femoral nerve block via catheter placed by experienced regional anesthesiologists at our institution Each patient will also receive spinal anesthesia for intra-operative pain control A standard midline skin incision with medial para-patellar arthrotomy will be performed followed by implantation of either a Next Gen ZimmerWarsaw IN or Natural Knee II Zimmer Warsaw IN or Posterior Femoral Component PFC Sigma DePuy Warsaw IN system Prior to surgery patients will be randomized to the saline or ropivicaine groups Both groups will receive their respective injection prior to implantation of the components
The posterior capsule of the knee will be divided in to four quadrants each receiving a saline or ropivicaine injection per randomization Safety measures will include standard pre-injection aspiration to check for vascular blush and intra-operative Doppler ultrasound to identify vascular structures in the posterior knee Additionally the anesthesiologist will not be blinded as heshe will be responsible for assuring the appropriate medication is used and will be closely monitoring for cardiac arrhythmias in the unlikely event that an intravascular injection occurs Post-operatively a standard bulky dressing will be applied All patients will be weight bearing as tolerated post-operative day 1 A fentanyl PCA will be initiated in the PACU and will be continued until post-operative day 2 Dosing will be calculated based on lean body mass Continuous femoral nerve blockade will continue until post-operative day 2 as well
Outcomes will include total PCA narcotic use visual analog pain scale with a diagram to localize pain and Ramsey sedation scores This data will be collected at the following intervals in the PACU 4 8 12 and 24 hours post-operatively We will also measure post-operative day 1 knee range of motion total ambulation distance and time to straight leg raise A standard Institutional Review Board IRB approved data collection sheet will be utilized
We hypothesize that total post-operative narcotic use visual analog pain scores and Ramsey sedation scores will be significantly lower in the study group posterior capsular ropivicaine 05 injection Additionally we anticipate the knee range of motion total ambulation distance and time to straight leg raise to be significantly improved as well
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| SPS 139715 | None | None | None |