Ignite Creation Date:
2024-07-17 @ 11:14 AM
Last Modification Date:
2024-10-26 @ 3:33 PM
Study NCT ID:
NCT06476977
Status:
RECRUITING
Last Update Posted:
2024-06-28
First Post:
2024-06-20
Brief Title:
Intrasynovial Digital Anesthesia in Trigger Finger
Sponsor:
Kevin Zuo
Organization:
University Health Network Toronto
Study Overview
Official Title:
Trigger Finger Corticosteroid Injection Pain Palmar Injection Versus Dorsal Intrasynovial Transthecal Injection
Status:
RECRUITING
Status Verified Date:
2024-08
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:
Trigger finger is a common disease of the hand involving swelling and inflammation of the tendon which flexes a finger causing catching locking andor pain Trigger finger is typically treated by hand surgeons with a steroid injection through the frontpalm side of the hand into the area near the tendon ie at the base of the affected finger This steroid injection is often combined with a local anesthetic numbing agent to help reduce short-term pain from the injection However the frontpalm side of the hand is known to be very sensitive and the steroid injection can be quite painful as the needle pierces the frontpalm skin
To reduce the pain of steroid injections for trigger finger a different approach involves performing the injection from the backdorsal side of the hand which is thought to be less sensitive and therefore less painful than the frontpalm side of the hand This technique is sometimes used and has been previously studied but it is not clear if it can offer less injection-related pain than standard treatment
Accordingly this study will be comparing short-term injection-associated pain between frontpalm side and backdorsal side steroid injections for trigger finger The study will also seek to understand what area of the hand is numbed by the anesthetic when doing a frontpalm side injection versus a backdorsal side injection of the hand Overall the investigators hypothesize that backdorsal side injections will be less painful than frontpalm side injections for trigger fingers and that the area of numbing from the anesthetic will be equivalent between both types of injections
To reduce the pain of steroid injections for trigger finger a different approach involves performing the injection from the backdorsal side of the hand which is thought to be less sensitive and therefore less painful than the frontpalm side of the hand This technique is sometimes used and has been previously studied but it is not clear if it can offer less injection-related pain than standard treatment
Accordingly this study will be comparing short-term injection-associated pain between frontpalm side and backdorsal side steroid injections for trigger finger The study will also seek to understand what area of the hand is numbed by the anesthetic when doing a frontpalm side injection versus a backdorsal side injection of the hand Overall the investigators hypothesize that backdorsal side injections will be less painful than frontpalm side injections for trigger fingers and that the area of numbing from the anesthetic will be equivalent between both types of injections
Detailed Description:
Trigger finger stenosing tenosynovitis is one of the most common pathologies assessed by hand surgeons in clinic Trigger finger involves inflammation or edema of the flexor tendon causing friction of the tendon at the site of the A1 annular pulley located at the base of the affected finger in the palm Trigger finger is typically managed non-surgically in a clinic setting with percutaneous corticosteroid injection CSI which can be successful in alleviating symptoms Patients with trigger finger who do not respond to CSI have incomplete relief andor who have recurrent symptoms may then receive surgical management with release of the A1 pulley
CSIs for trigger fingers are among the most common procedures performed by hand surgeons and are often administered multiple times in a single clinic day CSIs are frequently mixed 5050 with 1 lidocaine to provide post-injection analgesia for patients as well as symptomatic relief of the trigger finger if acutely inflamed These injections are commonly administered from a palmar approach into the A1 pulley of the affected digit Numerous technical variations of palmar trigger finger injections have been described involving either subcutaneous injection superficial to the flexor tendon sheath or intrasynovial transthecal injection into the flexor tendon sheath
Unfortunately given the rich sensory innervation of the palmar skin palmar injections are associated with significant pain as the needle pierces the skin An alternative technique is to provide digital anesthesia from a dorsal webspace approach injecting the local anesthetic into the flexor tendon synovial sheath This intrasynovial or transthecal technique has the benefit of a dorsal approach where the skin is less sensitive resulting in less pain 6 This technique has been described previously but is not familiar to many hand surgeons and is not routinely used in North America
Anecdotally patients report significantly decreased pain with the dorsal intrasynovial injection technique for trigger finger injections but pain scores have not been quantitatively evaluated or compared to the pain scores of traditional palmar trigger finger injections Furthermore it is not known what distribution of digital sensory blockade is achieved with this intrasynovial technique particularly on the dorsal surface of the digit which is discontinuous with the flexor tendon sheath and innervated by the sensory branch of the radial nerve
Accordingly it is hypothesized that injecting corticosteroids into the synovial sheath of the flexor tendon will result in less pain over 24 hours if performed through the dorsal webspace versus the palmar side of the affected digit
CSIs for trigger fingers are among the most common procedures performed by hand surgeons and are often administered multiple times in a single clinic day CSIs are frequently mixed 5050 with 1 lidocaine to provide post-injection analgesia for patients as well as symptomatic relief of the trigger finger if acutely inflamed These injections are commonly administered from a palmar approach into the A1 pulley of the affected digit Numerous technical variations of palmar trigger finger injections have been described involving either subcutaneous injection superficial to the flexor tendon sheath or intrasynovial transthecal injection into the flexor tendon sheath
Unfortunately given the rich sensory innervation of the palmar skin palmar injections are associated with significant pain as the needle pierces the skin An alternative technique is to provide digital anesthesia from a dorsal webspace approach injecting the local anesthetic into the flexor tendon synovial sheath This intrasynovial or transthecal technique has the benefit of a dorsal approach where the skin is less sensitive resulting in less pain 6 This technique has been described previously but is not familiar to many hand surgeons and is not routinely used in North America
Anecdotally patients report significantly decreased pain with the dorsal intrasynovial injection technique for trigger finger injections but pain scores have not been quantitatively evaluated or compared to the pain scores of traditional palmar trigger finger injections Furthermore it is not known what distribution of digital sensory blockade is achieved with this intrasynovial technique particularly on the dorsal surface of the digit which is discontinuous with the flexor tendon sheath and innervated by the sensory branch of the radial nerve
Accordingly it is hypothesized that injecting corticosteroids into the synovial sheath of the flexor tendon will result in less pain over 24 hours if performed through the dorsal webspace versus the palmar side of the affected digit
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