Ignite Creation Date:
2024-05-06 @ 2:40 AM
Last Modification Date:
2024-10-26 @ 11:22 AM
Study NCT ID:
NCT02106481
Status:
COMPLETED
Last Update Posted:
2016-08-03
First Post:
2014-03-27
Brief Title:
Comparing Femoral Nerve Catheters to Single Shot Femoral Nerve Blocks for Total Knee Replacement Surgery
Sponsor:
Eastern Maine Medical Center
Organization:
Eastern Maine Medical Center
Study Overview
Official Title:
Comparison of a Single Shot Femoral Nerve Block to Femoral Nerve Block Shot Plus Continuous Femoral Nerve Catheter for Total Knee Replacement Surgery a Randomized Blinded Controlled Trial
Status:
COMPLETED
Status Verified Date:
2016-08
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 compare two methods of pain control used during total knee joint replacement surgery The pain medication that will be used for this study is not experimental
The investigators will compare the single shot femoral nerve block SSFNB and Femoral Nerve Block FNB plus continuous femoral nerve catheter CFNC to determine which method gives patients better pain control increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication With either the single shot or the catheter the local numbing medication called ropivacaine will be used
The investigators will compare the single shot femoral nerve block SSFNB and Femoral Nerve Block FNB plus continuous femoral nerve catheter CFNC to determine which method gives patients better pain control increasing the capability to participate in physical therapy and decreasing the consumption of other pain medication With either the single shot or the catheter the local numbing medication called ropivacaine will be used
Detailed Description:
The study will be a randomized controlled blinded study with a sham control arm The patients will be randomized to either a single shot FNB with placement of a catheter on the skin sham control or a conventional CFNC with catheter
The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound A bolus of 05 ropivacaine will be injected around the femoral nerve A catheter would be placed on the skin without penetration with occlusive dressing applied over the site A standard size saline bag will be placed on the pump but will not be turned on The tubing will be opaque and a bag will be placed over the pump to blind the patient to the medication or lack of medication being administered The patient nursing staff and physical therapists will be blinded to the presence of a sham catheter The infusion will be labelled Study Drug R or Study Drug N in the electronic medicine prescription
The group randomized with active drug by CFNB would have a continuous femoral catheter placed using nerve stimulator and ultrasound Catheter will be bolused with 05 ropivacaine around the femoral nerve and occlusive dressing applied over the catheter
After placement of the femoral nerve block patients will be transported to the operating room and spinal anesthesia with bupivacaine and fentanyl will be performed Intra-operative sedation of propofol infusion will be titrated to the discretion of the anaesthesia team Patients will receive scheduled as well as rescue analgesia as per clinical pathway protocol
Patients with CFNB will receive ropivacaine 02 infusion the infusion rate will be dependent on the clinical judgement of the anaesthesiologist in the post anaesthesia care unit PACU after the spinal anaesthesia has worn off The infusion will be continued for the duration of the catheter 4am POD one Patients with SSFNB will not receive any infusion through the sham catheter
The catheters will be removed on post-operative day POD one at about 8 am Patients pain score using visual analogue score VAS will be assessed Functional status will be assessed by the physical therapist on POD one The therapist will assess and document the distance walked assistive device used level of assist needed to ambulate and knee proprioception or continued recommendation of the knee immobilizer
Patients will be assessed in the PACU and POD 1 and 2 Recordings will be made of total opioid consumption in morphine equivalents VAS score from 0-10 both at rest and on participation in physical therapy incidence of nausea and vomiting and functional status during physical therapy
The group with SSFNB will receive a femoral nerve block before the surgery in the pre-operative area guided by a nerve stimulator and ultrasound A bolus of 05 ropivacaine will be injected around the femoral nerve A catheter would be placed on the skin without penetration with occlusive dressing applied over the site A standard size saline bag will be placed on the pump but will not be turned on The tubing will be opaque and a bag will be placed over the pump to blind the patient to the medication or lack of medication being administered The patient nursing staff and physical therapists will be blinded to the presence of a sham catheter The infusion will be labelled Study Drug R or Study Drug N in the electronic medicine prescription
The group randomized with active drug by CFNB would have a continuous femoral catheter placed using nerve stimulator and ultrasound Catheter will be bolused with 05 ropivacaine around the femoral nerve and occlusive dressing applied over the catheter
After placement of the femoral nerve block patients will be transported to the operating room and spinal anesthesia with bupivacaine and fentanyl will be performed Intra-operative sedation of propofol infusion will be titrated to the discretion of the anaesthesia team Patients will receive scheduled as well as rescue analgesia as per clinical pathway protocol
Patients with CFNB will receive ropivacaine 02 infusion the infusion rate will be dependent on the clinical judgement of the anaesthesiologist in the post anaesthesia care unit PACU after the spinal anaesthesia has worn off The infusion will be continued for the duration of the catheter 4am POD one Patients with SSFNB will not receive any infusion through the sham catheter
The catheters will be removed on post-operative day POD one at about 8 am Patients pain score using visual analogue score VAS will be assessed Functional status will be assessed by the physical therapist on POD one The therapist will assess and document the distance walked assistive device used level of assist needed to ambulate and knee proprioception or continued recommendation of the knee immobilizer
Patients will be assessed in the PACU and POD 1 and 2 Recordings will be made of total opioid consumption in morphine equivalents VAS score from 0-10 both at rest and on participation in physical therapy incidence of nausea and vomiting and functional status during physical therapy
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