Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
NCT ID:
NCT06235606
Eligibility Criteria:
Inclusion criteria
* American Society of Anesthesiologist (ASA) status I-III
* Age 18-90 years old
* Scheduled for distal radial fracture fixation (Open reduction and internal fixation with volar approaching locking plate)
* Patients with informed consent to participate in the study
Exclusion criteria
* Revision surgery
* Previous fractures or surgery in the affected distal radius
* Surgery involving more than the affected arm
* Higher energy and high-grade fracture cases - road traffic accident, fall from height, open fractures, combined distal radius and distal ulna fractures, fractures requiring external fixation, fractures with severe articular comminution or severe metaphyseal extension, comminuted fractures requiring more than a single volar approach incision and a single volar locking plate implant
* Cases with painful conditions affecting the upper limb prior to surgery such as cervical spine, shoulder, elbow, other hand and wrist problems
* Cases with baseline (pre-injury) QuickDASH score worse than 10 out of 100
* Respiratory compromise (requires long term oxygen)
* History of seizures
* Pre-existing neurological disorder/deficit
* Chronic opioid user (3 months or more)
* Presence of chronic pain condition (pain duration over 3 months)
* Alcohol or substance abuse
* Psychiatric illness
* Impaired mental state
* Local infection
* Allergy to analgesic drugs: local anaesthetic drugs, paracetamol, non-steroidal anti-inflammatory drugs (NSAIDs), opioids
* Impaired renal function (defined as effective glomerular filtration rate \<30ml/min/1.73m2
* Impaired liver function (defined as plasma bilirubin over 34μmol/L; international normalized ratio \[INR\] ≥1.7, alanine aminotransferase \[ALT\] over 100U/L, aspartate aminotransferase \[AST\] over 100U/L)
* Coagulopathy (platelet count \<100,000/ml and/or INR ≥1.5) or the use of anticoagulants (not including aspirin) that precludes the use of supraclavicular BPB
* Pregnancy
* Patient refusal for regional nerve blocks
* Patient refusal to join the clinical trial
* Patient unable/unwilling to attend post-op rehabilitation programme
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
90 Years
Study:
NCT06235606
Study Brief:
Protocol Section:
NCT06235606