Ignite Creation Date:
2024-05-06 @ 5:28 PM
Last Modification Date:
2024-10-26 @ 2:30 PM
Study NCT ID:
NCT05328180
Status:
RECRUITING
Last Update Posted:
2024-02-23
First Post:
2022-04-07
Brief Title:
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease DELICATE
Sponsor:
Kuopio University Hospital
Organization:
Kuopio University Hospital
Study Overview
Official Title:
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease DELICATE A Randomized Controlled Trial
Status:
RECRUITING
Status Verified Date:
2024-02
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:
DELICATE
Brief Summary:
Introduction Carpal tunnel syndrome CTS is the most common peripheral nerve entrapment syndrome in Finland and worldwide Nowadays carpal tunnel release CTR surgery is often done in local anaesthesia Often the most painful event during CTR is the injection of the local anaesthetic Multiple different methods have been trialed and buffering the local anaesthetic seems to have good results in reducing the pain caused by the injection However no study has buffered long-acting local anaesthetic in CTR surgery and no study has accounted for the patients individual pain tolerance in the groups There are no comparisons of the results to minimal clinically important difference MCID for pain
Hypothesis In this study the investigators will evaluate the effects of buffering long-lasting local anaesthetic in wide-awake local anaesthesia no tourniquet WALANT CTR This studys hypothesis is that buffering long-acting local anaesthetic with sodium bicarbonate decreases the pain of the injection
The investigators also expect that buffering will reduce the number of needle stings felt during injection will result in as good perioperative pain control will lengthen the effect of anaesthetic will reduce postoperative painkiller usage will have at least as good functional outcome and greater patient satisfaction
Methods This study will enlist 116 patients and divide the patients into two groups in this double blinded randomized controlled trial One group receives non-buffered and the second group buffered local anaesthetic This studys primary outcome is to compare burning pressure needle sting and total pain the patient experienced between the groups The investigators will assess this using VAS and will compare the results to MCID The investigators secondary outcomes are comparisons of expected injection pain level and pain during CTR with VAS individual pain tolerancecatastrophising tendency with preoperative PCS-FINv20 form the number of needle stings the patient feels during the injection functional outcome and improvement of the patients symptoms with The Boston Carpal Tunnel Questionnaire Likert 5 before and after the surgery evaluation of patient satisfaction with net promoter score NPS and the use of painkillers duration of analgesia and pain levels using VAS after the surgery until the 3rd postoperative night
Hypothesis In this study the investigators will evaluate the effects of buffering long-lasting local anaesthetic in wide-awake local anaesthesia no tourniquet WALANT CTR This studys hypothesis is that buffering long-acting local anaesthetic with sodium bicarbonate decreases the pain of the injection
The investigators also expect that buffering will reduce the number of needle stings felt during injection will result in as good perioperative pain control will lengthen the effect of anaesthetic will reduce postoperative painkiller usage will have at least as good functional outcome and greater patient satisfaction
Methods This study will enlist 116 patients and divide the patients into two groups in this double blinded randomized controlled trial One group receives non-buffered and the second group buffered local anaesthetic This studys primary outcome is to compare burning pressure needle sting and total pain the patient experienced between the groups The investigators will assess this using VAS and will compare the results to MCID The investigators secondary outcomes are comparisons of expected injection pain level and pain during CTR with VAS individual pain tolerancecatastrophising tendency with preoperative PCS-FINv20 form the number of needle stings the patient feels during the injection functional outcome and improvement of the patients symptoms with The Boston Carpal Tunnel Questionnaire Likert 5 before and after the surgery evaluation of patient satisfaction with net promoter score NPS and the use of painkillers duration of analgesia and pain levels using VAS after the surgery until the 3rd postoperative night
Detailed Description:
None
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