Eastern Maine Medical Center
Bangor, Maine, 04401, United States
NCT Number: NCT02106481
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.
Looking for future studies?
Notify Me18 year–80 year
All sexes
Interventional
Not applicable
Bangor, Maine, 04401, United States
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 0.5 % 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 0.5 % 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 0.2% 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. Patient's 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Catheter will be bolused with 0.5 % ropivacaine around the femoral nerve and occlusive dressing applied over the catheter.
Patients with CFNB will receive ropivacaine 0.2% infusion (the infusion rate will be dependent on the clinical judgement of the anaesthesiologist)
Other names: 0.5% ropivacaine bolus followed by 0.2% infusion
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 0.5 % ropivacaine will be injected around the femoral nerve.
Other names: 0.5% ropivacaine
Time frame: 48 hours post operatively
Pain Analog Scale- 0-10 were 10 is the worst possible pain and 0 is no pain at all.
Time frame: 8 AM post op day 1
Patients will be asked if they had difficulty sleeping because of pain.
Time frame: 8 AM post op day 1
Nausea and Vomiting- Written questionnaire administer to patient. Did the patient experience Nausea? Yes/No. Using scale 0- no nausea, 1- nausea no vomiting, 2-vomiting, 3- persistent vomiting.
Time frame: 8 AM post op day 1, 48 hours post op, 3 months post op
Distance walked- Distance will be measured in meters and assistive device used (including knee immobilizer)
Time frame: 8 AM post op day 1, 48 hours post op, 3 months post op
Level of Assist for Ambulation- Independent (no device, timely, safely), modified independent (assistive device, safely or timeliness issues) supervision (requires standby assist, cueing), minimal assist (patient expends 75% of effort needed to completed task) , moderate assist (patient expends 50-74% of effort needed to completed task), max assist (patient expends 25-49% of effort needed to completed task), total assist (patient expends >25% of the effort needed to complete task).
Time frame: 8 AM post op day 1, 48 hours post op, 3 months post op
Hours until knee immobilizer is discharged - As a gauge of knee proprioception and quad strength the physical therapist will discharge the knee immobilizer when the patient can safely mobilize without the brace. The hours from surgery to discharge will be measured and >24 hours after surgery will be considered delayed discharge where <24 hours post op will be considered satisfactory.
Eastern Maine Medical Center
Other
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.
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT05924412
Acute Pain, Agnosia
Santiago, Metropolitan, Chile
View Trial DetailsNCT05003323
Agnosia, Analgesia
Pittsburgh, Pennsylvania, United States
View Trial DetailsNCT04351594
Agnosia, Arthritis
St. John's, Newfoundland and Labrador, Canada
View Trial DetailsNCT04592562
Agnosia, Arthritis
Chicago, Illinois, United States
View Trial Details