Using bicarbonate to reduce pain during carpal tunnel release surgery
aDjunct bicarbonatE in Local anaesthesIa for CarpAl Tunnel rElease (DELICATE): A Randomized Controlled Trial
This study tests if adding bicarbonate to a long-lasting painkiller can make the injection less painful for people having carpal tunnel release surgery.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 116 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Kuopio University Hospital Academic / other |
| Locations | 1 site (Kuopio, Pohjois-Savo) |
| Trial ID | NCT05328180 on ClinicalTrials.gov |
What this trial studies
This study evaluates the effectiveness of buffering long-acting local anaesthetic with sodium bicarbonate to reduce injection pain during carpal tunnel release surgery. It focuses on patients diagnosed with carpal tunnel syndrome who are scheduled for surgery under local anaesthesia without a tourniquet. The study aims to assess whether this method can improve patient comfort by comparing pain levels to established clinical benchmarks. The approach is novel as it considers individual pain tolerance and utilizes a long-acting anaesthetic.
Who should consider this trial
Good fit: Ideal candidates are patients diagnosed with carpal tunnel syndrome who are scheduled for carpal tunnel release surgery.
Not a fit: Patients with prior injuries to the median nerve, chronic renal failure, or allergies to lidocaine may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly reduce pain during carpal tunnel release surgery, improving patient experience and satisfaction.
How similar studies have performed: While buffering local anaesthetics has shown promise in other contexts, this specific approach for carpal tunnel release surgery is novel and has not been previously tested.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Kuopio, Pohjois-Savo
- Kuopio University hospital, Department of Orthopaedics, Traumatology and Hand Surgery — Kuopio, Pohjois-Savo, Finland (Recruiting)
Study contacts
- Study coordinator: Mikael Hytönen, MBBS
- Email: mikaelhy@student.uef.fi
- Phone: +358405819488
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.