Nerve Block, Anesthesia, Local, Forearm Fracture, Surgery, Brachial Plexus Block
Conditions
Keywords
Anesthetics, Local, Lidocaine, Ropivacaine
Brief summary
The aim of the study is to investigate how the combination of ropivacaine (a slow onset, long duration local anesthetic) with lidocaine (a rapid onset, shorter duration local anesthetic) affects the onset and duration of a lateral infraclavicular plexus brachialis (LIC) block in patients undergoing non-acute hand surgery.
Interventions
DRUGRopivacaine 0.5% Injectable Solution
30 mL Ropivacaine 5 mg/mL (= 150 mg Ropivacaine)
20 mL Ropivacaine 5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg) / ml (= 100 mg Ropivacaine + 200 mg Lidocaine)
20 mL Ropivacaine 7,5 mg/mL + 10 mL Lidocaine-Epinephrine (20 mg + 5 μg)/mL (= 150 mg Ropivacaine + 200 mg Lidocaine)
Sponsors
Nordsjaellands Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Patient who have given written informed consent to participate in the study, after having understood it Inclusion Criteria: * Scheduled for non-acute hand surgery in regional anesthesia * Scheduled for surgery on one of the following: 1) Antebrachium fractures or 2) Arthroplasty of a thumb base joint or 3) alloplasty of a thumb base joint
Exclusion criteria
* BMI \> 40 kg/m2 * Weight \< 60 kg * Age \< 18 years * ASA physical status classification system grade \> 3 * Allergy to experimental drugs * Patients who cannot cooperate with the examinations or treatment * Patients who do not understand or speak Danish * Patients with peripheral or central neurological disease or nerve damage with neurological effect on the upper extremity, where surgery is required
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total time to breakthrough pain | 24 hours | From the completion of the LIC block to first sensation of pain from the surgical area. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Total duration of motor blockade | 24 hours | From the completion of the LIC block until the ending of motor blockade |
| The onset of sensory block | Until max 45 minutes | From the completion of the LIC block to complete sensory blockade * Tested with refrigerator-cold glass vials. * A 3-point scale is used for cold sensation assessment: 1 point = normal sensation of cold, 2 points = reduced sensation of cold and 3 points = no cold sensation. * A complete sensory blockade is defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation). This outcome is measured until the complete block is obtained, but no longer than 45 minutes. \- If a complete sensory block is not obtained after 45 minutes, the LIC block is viewed as a failed block. |
| Total duration of sensory blockade | 24 hours | From the completion of the LIC block until the ending of sensory blockade |
| Degree of motor blockade | At complete sensory blockade and otherwise 45 minutes after block performance | Measured according to Manual Muscle Testing scale (4 point scale) * At the time of complete sensory blockade (defined as all four tested nerves obtaining three points on the 3-point scale (no cold sensation)), or if complete sensory blockade is not obtained, the degree of motor blockade is tested at 45 minutes. * Assessment is done using a 4-point Manual Muscle Testing Scale: 3 points = no difference, movement against resistance is possible, 2 points = a slight difference, movement against slight resistance is possible, 1 point = significant difference, movement is significantly compromised, 0 point = paralysis. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity at pain breakthrough | At pain breakthrough until a maximum of 24 hours after performed block. | Via Numeric Rating Scale (NRS) 0 - 10 (0 = no pain; 10 = worst pain imaginable) |
| Duration of maximum pain intensity after the blockade has ended | After the blockade has ended until a maximum of 24 hours after performed block. | Duration in hours:minutes |
| Occurence of adverse events (AE) and serious adverse events (SAE) | Follow up after 24 hours and 30 days | Based on phone interviews and medical records |
| Failed blockade | Evaluated 30 minutes after completed surgery | A block is viewed upon as failed if complete sensory block has not been achieved within 45 minutes or if supplemental local anaesthetic is needed before or during surgery. |
| The patient's experience of the treatment (patient satisfaction) | 24 hours | Via Numeric Rating Scale (NRS) 0 - 10 (0 = very dissatisfied; 10 = very satisfied) |
Countries
Denmark
Outcome results
None listed