Clinical trial NCT05328180: aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)
Official title: aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Carpal Tunnel Syndrome
Keywords: Carpal Tunnel Release
Bicarbonate
Local anaesthesia
Wide awake lidocain cum adrenalin no tourniquet
Pain
Carpal tunnel syndrome
Lead sponsor: Kuopio University Hospital
Sponsor class: OTHER
Collaborators: name: University of Eastern Finland
First posted: 2022-04-14
Enrollment: 116
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Two concurrent study groups
Primary purpose: TREATMENT

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 patient's 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 study's 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 study's 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 tolerance/catastrophising tendency with preoperative PCS-FINv2.0 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.


Eligibility criteria: Inclusion Criteria:

* Clinically and electrophysiologically diagnosed carpal tunnel syndrome
* Patients who are scheduled for carpal tunnel release surgery.

Exclusion Criteria:

* Associated disease or conditions, including earlier injury to median nerve, cervical radiculopathy, cubital tunnel syndrome and other peripheral neuropathy
* Chronic renal failure
* Rheumatoid arthritis
* Allergies to lidocaine
* Pregnancy
* Profound cognitive impairment
* Previous ipsilateral carpal tunnel decompression

Primary outcomes:
measure: Total pain level with visual analogic scale (VAS)
timeFrame: VAS is recorded immediately after the injection of local anaesthetic.
Secondary outcomes:
measure: Burning pain level with VAS
timeFrame: VAS is recorded immediately after the injection of local anaesthetic.
measure: Pressure pain level with VAS
timeFrame: VAS is recorded immediately after the injection of local anaesthetic.
measure: Needle sting pain level with VAS
timeFrame: VAS is recorded immediately after the injection of local anaesthetic.
measure: CTR pain level
timeFrame: VAS is recorded right after CTR surgery
measure: Analgesia duration
timeFrame: Every 4 hours after the surgery until 3rd postoperative night.
measure: Painkiller consumption
timeFrame: After the surgery until 3rd postoperative night.
measure: Number of needle stings
timeFrame: Immediately after the injection of local anaesthetic.
measure: Pain catastrophizing tendency
timeFrame: Before the surgery.
measure: Functional outcome
timeFrame: Before and 3 months after the surgery.
measure: Patient satisfaction
timeFrame: 3 months after the surgery.
measure: Expected pain level
timeFrame: Before the surgery.
Other outcomes:
Locations:
city: Kuopio
country: Finland
facility: Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery
state: Pohjois-Savo
Study officials:
affiliation: Kuopio University Hospital
name: Yrjänä Nietosvaara, Prof.
role: STUDY_DIRECTOR
References: