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prior to its planned completion as anticipated by the protocol due to lack of resources
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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.
If the patient is willing to participate and signs the consent, he/she will be randomized to one of the two treatment groups:
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 The needle will be withdrawn over the catheter.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| continuous IBP block | Active Comparator | 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 |
|
| single shot IBP block | Active Comparator | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 20ml bolus of 0.5% ropivicaine | Drug | Local anesthetic |
|
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores as Measured by the Visual Analog Scale | Pain scores at rest and with movement. | 72 hours |
| Participants Need for Pain Relief as Measured by Opiate Consumption | Amount of opiate consumption | 72 hours |
| Measure | Description | Time Frame |
|---|---|---|
| Quality of Recovery Score | Score of QoR survey to determine recovery status | 72 hours |
| Number of Subjects With Insomnia as Measured by Sleep Questionnaire | Quality of sleep first 2 nights post surgery |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nabil M Elkassabany | University of Pennsylvania | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores as Measured by the Visual Analog Scale | Pain scores at rest and with movement. | Analysis not done because study terminated prior to treatment. | Posted | 72 hours |
|
2 Years
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Anmol Madaan, Clinical Research Coordinator | University of Pennsylvania | 2156623778 | Anmol.Madaan@Pennmedicine.Upenn.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2018 | Mar 6, 2020 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 24, 2017 | Mar 6, 2020 | ICF_001.pdf |
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| ID | Term |
|---|---|
| D000092503 | Wrist Fractures |
| ID | Term |
|---|---|
| D014954 | Wrist Injuries |
| D001134 | Arm Injuries |
| D014947 | Wounds and Injuries |
| D050723 | Fractures, Bone |
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| 0.2% of ropivacaine at 8 milliliter/hour | Drug | Local anesthetic |
|
| 48 hours |
| 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 | 3 months |
| BG001 | 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 |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
|
| Primary | Participants Need for Pain Relief as Measured by Opiate Consumption | Amount of opiate consumption | Analysis not done because study terminated prior to treatment. | Posted | 72 hours |
|
|
| Secondary | Quality of Recovery Score | Score of QoR survey to determine recovery status | Study was terminated before patient analysis and follow ups were completed. | Posted | 72 hours |
|
|
| Secondary | Number of Subjects With Insomnia as Measured by Sleep Questionnaire | Quality of sleep first 2 nights post surgery | Analysis not done because study terminated prior to treatment. | Posted | 48 hours |
|
|
| 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 | Analysis not done because study terminated prior to treatment. | Posted | 3 months |
|
|
| 0 |
| 4 |
| 0 |
| 4 |
| 0 |
| 4 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 0 | 4 |
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