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BACKGROUND: Carpal tunnel syndrome (CTS) is the most common entrapment neuropathy of the upper extremity, and its surgical treatment is carpal tunnel release (CTR). It is mostly performed in local anesthesia. There are no clinical randomized controlled trials (RCTs) comparing local infiltration anesthesia with or without a distal median nerve block in CTR. The aim of the PERSONNEL trial (carPal tunnEl ReleaSe lOcal iNfiltratioN mEdian bLockade) is to assess whether a distal median nerve block reduces pain during and after the procedure in addition to local anesthesia. METHODS: This is a single-center randomized clinical superiority trial comparing local anesthesia alone and local anesthesia with a distal median nerve block for CTR in patients with CTS. Adult patients will be randomized in one university hospital in Finland, and the intended sample size is 118. The primary outcome is the mean pain level after the procedure during 72 h using a visual analogue scale (VAS). The secondary outcomes include expected pain; pain during the injection of the anesthetic solution caused by pressure, burning, needle sting, and total pain; worst pain during the surgery; duration of anesthesia; number of experienced needle stings; Boston Carpal Tunnel Syndrome Questionnaire (BCTSQ); pain killer consumption;, patient satisfaction using Net Promoter Score (NPS); and complications. DISCUSSION: Patient satisfaction is a crucial factor in modern healthcare. A distal median nerve block may reduce pain during and after CTR, potentially increasing patient satisfaction with the given treatment. It can also be hypothesized that better postoperative pain control may prevent complications, for example, complex regional pain syndrome. However, we lack adequate evidence to justify the use of distal median nerve block, which can itself predispose patients to complications, for example, median nerve injury. Therefore, there is a need for adequate RCTs to assess its efficacy. The results of this study can be used to optimize anesthesia for carpal tunnel surgery, improve patient satisfaction, and possibly prevent complications. REGISTRATION: ClinicalTrials.gov NCT05372393.
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INTRODUCTION: Carpal tunnel syndrome is a common disorder affecting a substantial portion of the general population. Surgical intervention is often deemed necessary, with the median nerve release being one of the most frequent operations. Optimising all the aspects of this procedure can enhance patient satisfaction with the treatment. METHODS AND ANALYSIS: We aim to determine the differences in the aesthetic outcome of the scar as well as the pain experienced during the healing process between the use of absorbable and non-absorbable sutures. The primary outcome measure will be the patients' subjective satisfaction with the aesthetic appearance of the scar 1 year after the operation. Secondary outcomes will include a similar evaluation of the aesthetics performed by a blinded outcome assessor, as well as pain experienced by the patients during the 2 weeks postoperatively. The severity and improvement of the patients' symptoms will also be measured by a Finnish version of the Boston Carpal Tunnel Questionnaire. Costs will be evaluated for both groups. Safety of the wound closure will be followed and reported. ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District (2319/2021). The trial will be conducted in accordance with the principles of Good Clinical Practice and the Declaration of Helsinki. The results will be disseminated through publication in peer-reviewed journals. TRIAL REGISTRATION NUMBER: NCT05503719.
Asunto(s)
Síndrome del Túnel Carpiano , Humanos , Síndrome del Túnel Carpiano/cirugía , Cicatriz , Resultado del Tratamiento , Dolor , Suturas , Ensayos Clínicos Controlados Aleatorios como AsuntoRESUMEN
INTRODUCTION: This study aims to compare the effectiveness of buffered and non-buffered long-acting local anaesthetics in pain relief during and after carpal tunnel release (CTR) surgery. Carpal tunnel syndrome (CTS) is the most common peripheral nerve entrapment syndrome. Surgical treatment of CTS, CTR, is the most common hand surgical operation. CTR is usually performed under local anaesthesia, the application of which is often the most painful event during the procedure. One important aspect of patient satisfaction is adequate pain management during and after CTR. Long-acting local anaesthetics provide good postoperative pain control. Adjunct bicarbonate has been shown to reduce pain during injection of local anaesthetic and to prolong its analgesic effect. To date, no published randomised controlled trial has compared buffered to non-buffered long-acting local anaesthetic during CTR. METHODS AND ANALYSIS: The study will randomly assign 116 patients with CTS to receive buffered or non-buffered mixtures of lidocaine and bupivacaine with epinephrine before CTR. The primary outcome is overall pain experienced during the injection of local anaesthetic, assessed with the Visual Analogue Scale. The secondary outcomes are pain intensity from the injection and during CTR, use of painkillers and pain intensity every 4 hours until third postoperative night, symptom severity and functional status preoperatively and at 3 months after surgery, and patient-rated outcome measures at 3 months after surgery. ETHICS AND DISSEMINATION: This protocol was approved by the Research Ethics Committee of the Northern Savo Hospital District (2311/2021). The study will be performed according to the principles of good clinical practice and the Declaration of Helsinki. The results are expected to be presented in an international hand surgical conference and the manuscript to be sent to a hand surgery-orientated peer-reviewed journal during 2024. TRIAL REGISTRATION NUMBER: This study is registered to clinicaltrials.gov, study ID NCT05328180.
