Onset and duration of nerve block of the forearm in which 2 techniques will be compared; nerve block by injection at one site compared to injections at two site in the forearm; a blinded randomized controlled study.

Phase 1

• Conditions: Dupuytren contrature and Carpal Tunnel syndrome; MedDRA version: 20.0Level: PTClassification code 10013873Term: Dupuytren's contracture operationSystem Organ Class: 10042613 - Surgical and medical procedures; MedDRA version: 20.0Level: PTClassification code 10007697Term: Carpal tunnel syndromeSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

• Registration Number: EUCTR2017-003694-34-BE
• Lead Sponsor: Ziekenhuis Oost-Limburg

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2017-10-02
• Last Update Posted: 27 May 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

- adult patients between 18 and 80 years
- scheduled to undergo daycare surgery for carpal tunnel syndrome or Dupuytren's contracture release under peripheral nerve blocks
- ASA I, II or III
- Able to demonstrate sensory function by exhibiting sensitivity to cold, pinprick and light touch
- Scheduled to undergo primary hand surgery
- Able to understand the Dutch language, purpose and risks of the study
- Able to provide informed consent and authorization to use protected health information, adhere to the study visit schedule and complete all study assessments

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 6

Exclusion Criteria

?Currently pregnant or, nursing patients
?History of hypersensitivity to local anesthetics
?Contraindication to bupivacaine, paracetamol, ketorolac, oxycodone or morphine
?Medical condition that will make it difficult to assess sensory distributions of peripheral nerves or to communicate with staff
?Suspected or known recent history (< 3 months) of drug or alcohol abuse
?Concurrent physical condition that may require analgesic treatment (such as NSAID or opioid) in the postsurgical period for pain that is not strictly related to Dupuytren’s contracture and which may confound the postsurgical assessments
?Infection at the planned block site
?Initiation of treatment with any of the following medications within 1 month of study drug administration or if the medication(s) are being given to control pain: selective serotonin reuptake inhibitors (SSRIs), selective norepinephrine reuptake inhibitors (SNRIs), gabapentin, pregabalin (Lyrica®), or duloxetine (Cymbalta®)
?Body weight <40 kg (88 pounds) or a body mass index >44 kg/m2
?Uncontrolled anxiety, psychiatric, or neurological disorder that might interfere with study assessments
?Any chronic neuromuscular deficit affecting the peripheral nerves or muscles of the surgical extremity
?Any chronic condition or disease that would compromise neurological or vascular assessments
?Presence of preexisting coagulation disorders
?Baseline neurological deficits

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified