Trigger finger De Quervains tenosynovitis Carpal tunnel syndrome MedDRA version: 21.0 Level: PT Classification code 10044654 Term: Trigger finger System Organ Class: 10028395 - Musculoskeletal and connective tissue disorders
Conditions
Interventions
Trade Name: Lidocaine 1%
Product Name: Lidocaine 1%
Product Code: LD1002
Pharmaceutical Form: Injection
INN or Proposed INN: lidocaine hydrochloride
CAS Number: 73-78-9
Current Sponsor code: Lidocaine
Sponsors
University Hospitals Plymouth NHS Trust
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Male or female ages >/= 18 years. A clinical diagnosis of trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome made by a consultant physician. Treatment with corticosteroid injection is recommended by the doctor and agreed by the patient. Patient is willing and able to give informed consent for participation in the study. Are the trial subjects under 18? no Number of subjects for this age range: 0 F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 50 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
Exclusion criteria: Previous surgery for the condition being treated at the desired location of injection (Previous corticosteroid injection elsewhere in the hand or wrist does not exclude the patient from the trial). Previous steroid injection for the condition being treated at the desired location of injection (Previous surgery elsewhere in the hand or wrist does not exclude the patient from the trial). Clinical suspicion of local or systematic sepsis or infection. History of hypersensitivity to the corticosteroid or local anaesthetic. Pregnant or breast-feeding females. Unable to understand and complete self-report questionnaires written in English.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To determine whether pain experienced at 1-hour after a corticosteroid injection to the hand and wrist is no worse than (not inferior to) the pain experienced after a corticosteroid and local anaesthetic injection. ;Secondary Objective: The secondary objectives; i) Investigate whether there is a difference in pain VAS scores during the 24-hours after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. ii) Investigate whether there is a difference in the pain VAS scores at the time of the corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. iii) Investigate the difference in the additional analgesia required and in the functional use of the hand during the first 3 hours following a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. ;Primary end point(s): Investigate whether there is a difference in pain VAS scores at 1-hour after a corticosteroid injection for trigger finger, de Quervains tenosynovitis or carpal tunnel syndrome co-administered with or without local anaesthetic. ;Timepoint(s) of evaluation of this end point: 1 hour post injection. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Investigate whether there is a difference in pain after 24 hours. Investigate a difference in pain VAS scores at the time of injection with and without local anaesthetic. Investigate the difference in additional analgesia required in the functional use of the hands in the first three hours following injection with or without local anaesthetic.;Timepoint(s) of evaluation of this end point: Before injection, 5 minutes after, 1 hour, 2 hours, 3 hours, 24 hours post injection. | — |
Countries
United Kingdom
Contacts
Public ContactCharles Gozzard
University Hospitals Plymouth NHS Trust
Outcome results
None listed