aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE)

Carpal Tunnel Syndrome Clinical Trial

— DELICATE  

Official title:

aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05328180
• Other study ID #: KUH5203139
• Status: Recruiting
• Phase: N/A
• Start date: September 21, 2022
• Est. completion date: November 2025

Study information

• Verified date: February 2024
• Source: Kuopio University Hospital
• Contact: Mikael Hytönen, MBBS
• Phone: +358405819488
• Email: mikaelhy[@]student.uef.fi
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 116
• Est. completion date: November 2025
• Est. primary completion date: June 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Carpal Tunnel Syndrome

Intervention

Other:
• Sodium bicarbonate
A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5% is buffered with 7.5% sodium bicarbonate in 1:10.
• Control arm
A 50/50 solution of lidocaine with adrenalin 1% and bupivacaine with adrenalin 0.5%.

Locations

Country	Name	City	State
Finland	Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery	Kuopio	Pohjois-Savo

Sponsors (2)

Lead Sponsor	Collaborator
Kuopio University Hospital	University of Eastern Finland

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total pain level with visual analogic scale (VAS)	The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse. The investigators calculate the mean VAS level for each group and compare the results to find statistically and clinically relevant difference. Clinically relevant difference is evaluated by comparing the VAS difference to MCID.	VAS is recorded immediately after the injection of local anaesthetic.
Secondary	Burning pain level with VAS	The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse.	VAS is recorded immediately after the injection of local anaesthetic.
Secondary	Pressure pain level with VAS	The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse.	VAS is recorded immediately after the injection of local anaesthetic.
Secondary	Needle sting pain level with VAS	The investigators evaluate the total pain with 0-100 mm visual analogue scale (VAS). In VAS higher number means more pain and is therefore worse.	VAS is recorded immediately after the injection of local anaesthetic.
Secondary	CTR pain level	The investigators evaluate the maximum pain level patient experiences during CTR surgery with visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.	VAS is recorded right after CTR surgery
Secondary	Analgesia duration	The investigators assess the length of the anaesthesia by recording the pain level with visual analogue scale (VAS) every 4 hours. This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.	Every 4 hours after the surgery until 3rd postoperative night.
Secondary	Painkiller consumption	The investigators record the painkiller consumption after the surgery.	After the surgery until 3rd postoperative night.
Secondary	Number of needle stings	The investigators ask the patient to report how many needle stings the patient felt during the injection of the local anaesthetic.	Immediately after the injection of local anaesthetic.
Secondary	Pain catastrophizing tendency	The investigators ask the patients to fill pain catastrophizing tendency evaluating form (PCS-FINv2.0) before the surgery in order to evaluate the pain levels between the experimental and control group. It has 13 questions and scores between 0-52. Higher score means higher pain catastrophizing tendency.	Before the surgery.
Secondary	Functional outcome	The investigators ask the patients to evaluate symptoms and functional outcome using the Boston Carpal Tunnel Questionnaire (BTCQ). It has 11 questions for symptoms of carpal tunnel syndrome and scores between 11 and 55. Higher score means more symptoms. BTCQ also has 8 questions for functionality of hand and it has scores between 8 and 40. Higher scores mean worse function of the hand.	Before and 3 months after the surgery.
Secondary	Patient satisfaction	The investigators ask the patients to evaluate the surgery experience with net promoter score (NPS). NPS has 10 steps and higher value indicates greater satisfaction.	3 months after the surgery.
Secondary	Expected pain level	The investigators ask the patients to evaluate the pain the patient expect to experience during administration of local anaesthetic using visual analogue scale (VAS). This study uses 0-100 mm VAS. In VAS higher number means more pain and is therefore worse.	Before the surgery.