Distal Radius Fracture, Post Operative Pain Control
Conditions
Keywords
infraclavicular brachial plexus block, quality of recovery score, pain score, disability assessment of shoulder and hand questionnaire
Brief summary
The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to continuous catheter nerve block done in adult patients who have under gone surgery to repair distal radius fractures. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison.
Detailed description
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups: 1. Single shot block 2. Continuous catheter In the institution investigators usually advocate for regional anesthesia and intravenous sedation for the repair of open fracture of the distal radius. Patients will be monitored during block performance with standard ASA monitors. All patients will receive 2 L of oxygen via a nasal cannula. Sedatives will be titrated to effect. Midazolam 1-2 mg, and fentanyl 50-100 mcg will be used for sedation. Block time out will be preformed according to standard operating procedure. All blocks will be done under ultrasound guidance. Sonosite S nerve machine will be used with a low frequency curvilinear (C5) US probe with 2-5 MHZ frequency. Both single shot and continuous ICB will be performed according to the SOP in the department. Ultrasound survey of the deltopectoral groove below the clavicle will take place. The axillary artery and the three cords (posterior, medial and lateral) of the brachial plexus will be identified in short axis view deeper to the pectoralis minor muscle. For single shot blocks: A 4 inch 21 gauge single shot (B-Braun) needle will be introduced in-plane towards the posterior cord of the brachial plexus and 1-2 mL of dextrose 5% (D5%) bolus will be used to verify correct placement of the needle in the vicinity of the posterior cord and adequate spread pattern to both lateral and medical cord. 20 ml of of Ropivicaine 0.5% will be injected through the needle with intermittent aspiration after each 5 ml bolus injection. For the continuous block: A 4 gauge 18 inch tuohy needle ( B -Braun) will be introduced towards the posterior cord as above. When the needle tip and the pattern of spread is confirmed using D5% solution, a 21 gauge catheter will be introduced 2 cm beyond the needle tip under ultrasound visualization. The needle will be withdrawn over the catheter. Injection of a total of 20 ml of ropivacaine 0.5% ( in divided 5 ml boluses with intermittent aspiration) will take place through the catheter while observing the spread of local anesthetic under ultrasound. The catheter hub will be affixed to the upper lateral chest with sterile occlusive dressings and an anchoring device. Block success will be defined as a change in cutaneous sensation to touch with an alcohol pad in the posterior, medial and lateral cord distribution over the forearm and the hand within 30min after injection. Subjects with successful catheter placement per protocol and nerve block onset will be retained in the study. Subjects with a failed catheter insertion or misplaced catheter indicated by a lack of sensory changes will have their catheter replaced or will be single shot blocked and withdrawn from the study. Intraoperative sedation will consist of intermittent boluses of midazolam (1-2 mg), fentanyl (50-100 mcg) and propofol infusion, titrates to sedation and patient comfort (25-50 mcg/kg/min). All patients will receive prophylaxis for postoperative nausea and vomiting (PONV) during surgery. The protocol for prophylaxis against PONV includes administration of 4 mg of dexamethasone after induction of anesthesia and 4 mg of ondansetron 20 minutes before recovery from anesthesia. Dexamethasone is withheld if the patient has poorly controlled diabetes mellitus (DM). Uncontrolled DM will be defined as random blood glucose above 250 mg/dl.
Interventions
Local anesthetic
DRUG0.2% of ropivacaine at 8 milliliter/hour
Local anesthetic
Sponsors
University of Pennsylvania
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients scheduled for open reduction and internal fixation of a distal radius fracture * American Society of Anesthesiologists (ASA) physical status I -III * Mentally competent and able to give consent for enrollment in the study
Exclusion criteria
* Patient younger than 18 years old * Allergy to local anesthetics, systemic opioids (fentanyl, morphine, hydromorphone and any of the drugs included in the standard of care * Patients opting to go under general anesthesia and those refusing the block * Chronic pain syndromes; Patients will be defined to have chronic pain if they are using regular daily doses of systemic narcotics for the past 6 months prior to the surgery * BMI of 40 or more
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain Scores as Measured by the Visual Analog Scale | 72 hours | Pain scores at rest and with movement. |
| Participants Need for Pain Relief as Measured by Opiate Consumption | 72 hours | Amount of opiate consumption |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Recovery Score | 72 hours | Score of QoR survey to determine recovery status |
| Number of Subjects With Insomnia as Measured by Sleep Questionnaire | 48 hours | Quality of sleep first 2 nights post surgery |
| Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire | 3 months | Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Continuous IBP Block Subjects will receive 60 hour continuous infraclavicular brachial plexus block (0.2% of ropivacaine at 8 milliliter/hour) with initial four intermittent 5ml bolus (20ml) of 0.5% Ropivicaine given preoperatively to help with operative and postoperative pain
20ml bolus of 0.5% ropivicaine: Local anesthetic
0.2% of ropivacaine at 8 milliliter/hour: Local anesthetic | 4 |
| Single Shot IBP Block Subjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain
20ml bolus of 0.5% ropivicaine: Local anesthetic | 4 |
| Total | 8 |
Baseline characteristics
| Characteristic | Single Shot IBP Block | Total | Continuous IBP Block |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 4 Participants | 8 Participants | 4 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 4 participants | 4 participants | 4 participants |
| Sex: Female, Male Female | 3 Participants | 5 Participants | 2 Participants |
| Sex: Female, Male Male | 1 Participants | 3 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 4 | 0 / 4 |
| other Total, other adverse events | 0 / 4 | 0 / 4 |
| serious Total, serious adverse events | 0 / 4 | 0 / 4 |
Outcome results
Primary
Pain Scores as Measured by the Visual Analog Scale
Pain scores at rest and with movement.
Time frame: 72 hours
Population: Analysis not done because study terminated prior to treatment.
Primary
Participants Need for Pain Relief as Measured by Opiate Consumption
Amount of opiate consumption
Time frame: 72 hours
Population: Analysis not done because study terminated prior to treatment.
Secondary
Number of Subjects With Insomnia as Measured by Sleep Questionnaire
Quality of sleep first 2 nights post surgery
Time frame: 48 hours
Population: Analysis not done because study terminated prior to treatment.
Secondary
Quality of Recovery Score
Score of QoR survey to determine recovery status
Time frame: 72 hours
Population: Study was terminated before patient analysis and follow ups were completed.
Secondary
Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire
Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery
Time frame: 3 months
Population: Analysis not done because study terminated prior to treatment.