Ignite Creation Date:
2024-05-06 @ 3:49 AM
Last Modification Date:
2024-10-26 @ 11:39 AM
Study NCT ID:
NCT02382744
Status:
COMPLETED
Last Update Posted:
2018-04-02
First Post:
2015-02-18
Brief Title:
Saphenous Nerve Block for Foot and Ankle Surgery
Sponsor:
University of British Columbia
Organization:
University of British Columbia
Study Overview
Official Title:
A Comparison of Ultrasound-Guided and Ultrasound-Guided With Nerve Stimulation Saphenous Nerve Blockade Utilizing the Transsartorial Approach
Status:
COMPLETED
Status Verified Date:
2017-09
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:
Patients undergoing foot and ankle surgery have the option of having a nerve block administered by their Anesthesiologist The nerve block numbs the foot and results in less post-operative nausea and vomiting and better pain control Two different techniques for blocking the saphenous nerve to the foot have been described and are both commonly used at St Pauls hospital The goal of this study is to compare the success rates of these two techniques
Detailed Description:
Purpose Hypothesis This clinical study is a prospective controlled randomized single-blinded trial designed to investigate the hypothesis that ultrasound-guided blockade of the saphenous nerve in conjunction with nerve stimulation has a higher success rate when compared to ultrasound alone These research interventions represent what is considered to be an improvement on the standard practice at St Pauls which is to block the saphenous nerve with one of any number of saphenous nerve blocks using a number of different techniques ie ultrasound-guided nerve stimulation blind field block the effectiveness of which has been inconsistent The purpose of this study is to identify if one technique has a great success rate over another which would ultimately result in increased success rates of saphenous nerve blocks and patient care
Study Design The study will be a randomized single-blinded trial of 80 subjects who are undergoing foot and ankle surgery Informed consent will be obtained from all study subjects Subjects will be randomized to one of two saphenous nerve block techniques to be administered by an experienced regional anesthesiologist at St Pauls Hospital Once the nerve block is completed the success will be evaluated by an investigator blinded to the procedure Once the 30min evaluation is completed anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist The subject will then be contacted at 2 and 7 days after block administration to assess for delayed complications
Intravenous access will be gained and non-invasive blood pressure measurements will be recorded every five minutes Continuous electrocardiography and oxygen saturation monitoring will be maintained throughout the procedure and for at least 60 minutes afterwards Light sedation will be provided with the goal of maintaining verbal contact with the subject throughout the procedure Where clinically appropriate the study block may be preceded by an ultrasound-guided popliteal sciatic nerve block at the discretion of the attending anesthesiologist
Saphenous nerve blockade will be preformed using a transsartorial approach Subjects in both groups will be positioned prone The ultrasound probe will be placed in the transverse plane on the medial aspect of the thigh 3-5cm cephalad to the superior border of the patella area marked An attempt will then be made to identify the saphenous nerve which runs deep to the sartorius muscle within the subsartorial fascial plane The nerve will appear hyperechoic round or oval shaped The anesthesiologist will have a maximum scan time of 3 minutes prior to needle entry Up to 5 mL of 1 Lidocaine will be used for skin infiltration of the injection site The block will then be preformed as to the protocols below depending on group allocation A thirty minute evaluation of the saphenous nerve block will occur during the normal monitoring period after the placement of a block
Following completion of the thirty-minute evaluation anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist This may include spinal or general anesthesia
All subjects will be contacted by telephone at two and seven days post procedure for a follow up interview to assess for delayed complications associated with the procedure
The medications used for the nerve blocks in the study will include only ropivacaine 05 and lidocaine 1 For subject sedation midazolam and fentanyl will be used None of these medications are considered study drugs rather they are commonly used anesthetic medications While used in the study these drugs themselves are not being investigated The same medications will be used on subjects not enrolled in the study
Study Treatment Group 1 - Saphenous nerve block using ultrasound guidance The needle will be placed with the needle tip in close proximity 1-2 mm of the target structures the saphenous nerve if visible or in the subsartorial facial plane of the sartorius muscle if the nerve is not visible A total of 10 mL of 05 ropivacaine will be used for the block Before injection of any local anesthetic a gentle aspiration will be preformed with a second aspiration after 5 mL of ropivacaine has been injected Once injection of local anesthetic has commenced small needle adjustments are allowed to enhance spread This will be done at the discretion of the regional anesthesiologist performing the block
Study Treatment Group 2 - Saphenous nerve blockade using ultrasound guidance and nerve stimulation The needle will be place with the needle tip in close proximity 1-2 mm of the target structure the saphenous nerve if visible or in the subsartorial fascial plane if the nerve is not visible The Pajunk MultiStim SENSOR nerve stimulator will then be turned on starting at 10 milliamp mA until a tapping sensation is elicited in the medial or anterior aspect of the ankle The amplitude of the nerve stimulator will then be gradually decreased with maintenance of the tapping sensation by making small adjustments in needle location The end-point for nerve localization will be a tapping sensation in the area of the medial malleolus at 06 mA The anesthesiologist will have a maximum search time of 5 minutes from needle entry to elicitation of the tapping sensation Once a tapping sensation is elicited in the 06 mA range 10 mL of 05 ropivacaine will be injected at the site If a tapping sensation is elicited but not 06 mA within 5 minutes then 10 mL of 05 ropivacaine will be injected at the site where the lowest amplitude tapping sensation was elicited If no tapping sensation is elicited from the subject after 5 minutes an injection of 10 mL of ropivacaine will be made below the Sartorius muscle in the subsartorial fascial plane Before injection of any local anesthetic a gentle aspiration will be preformed with a second aspiration after 5 mL of ropivacaine has been injected Once injection of local anesthetic has commenced small needle adjustments are allowed to enhance spread This will be done at the discretion of the regional anesthesiologist performing the block
Study Design The study will be a randomized single-blinded trial of 80 subjects who are undergoing foot and ankle surgery Informed consent will be obtained from all study subjects Subjects will be randomized to one of two saphenous nerve block techniques to be administered by an experienced regional anesthesiologist at St Pauls Hospital Once the nerve block is completed the success will be evaluated by an investigator blinded to the procedure Once the 30min evaluation is completed anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist The subject will then be contacted at 2 and 7 days after block administration to assess for delayed complications
Intravenous access will be gained and non-invasive blood pressure measurements will be recorded every five minutes Continuous electrocardiography and oxygen saturation monitoring will be maintained throughout the procedure and for at least 60 minutes afterwards Light sedation will be provided with the goal of maintaining verbal contact with the subject throughout the procedure Where clinically appropriate the study block may be preceded by an ultrasound-guided popliteal sciatic nerve block at the discretion of the attending anesthesiologist
Saphenous nerve blockade will be preformed using a transsartorial approach Subjects in both groups will be positioned prone The ultrasound probe will be placed in the transverse plane on the medial aspect of the thigh 3-5cm cephalad to the superior border of the patella area marked An attempt will then be made to identify the saphenous nerve which runs deep to the sartorius muscle within the subsartorial fascial plane The nerve will appear hyperechoic round or oval shaped The anesthesiologist will have a maximum scan time of 3 minutes prior to needle entry Up to 5 mL of 1 Lidocaine will be used for skin infiltration of the injection site The block will then be preformed as to the protocols below depending on group allocation A thirty minute evaluation of the saphenous nerve block will occur during the normal monitoring period after the placement of a block
Following completion of the thirty-minute evaluation anesthetic care will be provided according to regular institutional practice and at the discretion of the attending anesthesiologist This may include spinal or general anesthesia
All subjects will be contacted by telephone at two and seven days post procedure for a follow up interview to assess for delayed complications associated with the procedure
The medications used for the nerve blocks in the study will include only ropivacaine 05 and lidocaine 1 For subject sedation midazolam and fentanyl will be used None of these medications are considered study drugs rather they are commonly used anesthetic medications While used in the study these drugs themselves are not being investigated The same medications will be used on subjects not enrolled in the study
Study Treatment Group 1 - Saphenous nerve block using ultrasound guidance The needle will be placed with the needle tip in close proximity 1-2 mm of the target structures the saphenous nerve if visible or in the subsartorial facial plane of the sartorius muscle if the nerve is not visible A total of 10 mL of 05 ropivacaine will be used for the block Before injection of any local anesthetic a gentle aspiration will be preformed with a second aspiration after 5 mL of ropivacaine has been injected Once injection of local anesthetic has commenced small needle adjustments are allowed to enhance spread This will be done at the discretion of the regional anesthesiologist performing the block
Study Treatment Group 2 - Saphenous nerve blockade using ultrasound guidance and nerve stimulation The needle will be place with the needle tip in close proximity 1-2 mm of the target structure the saphenous nerve if visible or in the subsartorial fascial plane if the nerve is not visible The Pajunk MultiStim SENSOR nerve stimulator will then be turned on starting at 10 milliamp mA until a tapping sensation is elicited in the medial or anterior aspect of the ankle The amplitude of the nerve stimulator will then be gradually decreased with maintenance of the tapping sensation by making small adjustments in needle location The end-point for nerve localization will be a tapping sensation in the area of the medial malleolus at 06 mA The anesthesiologist will have a maximum search time of 5 minutes from needle entry to elicitation of the tapping sensation Once a tapping sensation is elicited in the 06 mA range 10 mL of 05 ropivacaine will be injected at the site If a tapping sensation is elicited but not 06 mA within 5 minutes then 10 mL of 05 ropivacaine will be injected at the site where the lowest amplitude tapping sensation was elicited If no tapping sensation is elicited from the subject after 5 minutes an injection of 10 mL of ropivacaine will be made below the Sartorius muscle in the subsartorial fascial plane Before injection of any local anesthetic a gentle aspiration will be preformed with a second aspiration after 5 mL of ropivacaine has been injected Once injection of local anesthetic has commenced small needle adjustments are allowed to enhance spread This will be done at the discretion of the regional anesthesiologist performing the block
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