Distal Radius FractureNCT02744352
Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair
A study testing 20ml bolus of 0.5% ropivicaine and 0.2% of ropivacaine at 8 milliliter/hour in people with Distal Radius Fracture and Post Operative Pain Control, run by University of Pennsylvania at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Distal Radius Fracture, Post Operative Pain Control
- What is being tested?
- 20ml bolus of 0.5% ropivicaine and 0.2% of ropivacaine at 8 milliliter/hour
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2016to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Pennsylvania
Philadelphia, Pennsylvania, 19104
About this study
Official title: Comparison Between Single Shot Versus Continuous Infraclavicular Brachial Plexus Block for Postoperative Analgesia After Distal Radius Fracture: A Prospective Randomized Open Label Study
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.
Read the 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:
- Single shot block
- 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.
- Being tested
- 20ml bolus of 0.5% ropivicaine, 0.2% of ropivacaine at 8 milliliter/hour
- Keywords
- infraclavicular brachial plexus block, quality of recovery score, pain score, disability assessment of shoulder and hand questionnaire
- Medical subject headings
- Wrist Fractures
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
20ml bolus of 0.5% ropivicaineDrug
Local anesthetic
0.2% of ropivacaine at 8 milliliter/hourDrug
Local anesthetic
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Drug: 20ml bolus of 0.5% ropivicaine; Drug: 0.2% of ropivacaine at 8 milliliter/hour |
| 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 Receives: Drug: 20ml bolus of 0.5% ropivicaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain Scores as Measured by the Visual Analog Scale
Pain scores at rest and with movement.
Measured: 72 hours
Participants Need for Pain Relief as Measured by Opiate Consumption
Amount of opiate consumption
Measured: 72 hours
Secondary outcomes (3)
Quality of Recovery Score
Score of QoR survey to determine recovery status
Measured: 72 hours
Number of Subjects With Insomnia as Measured by Sleep Questionnaire
Quality of sleep first 2 nights post surgery
Measured: 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
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Apr 2016 (estimated)
- Study startOct 2016
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: prior to its planned completion as anticipated by the protocol due to lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Distal Radius FractureStudies of the same condition, open and under way.
- More trials run by University of PennsylvaniaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabil M Elkassabany, Principal investigator, University of Pennsylvania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02744352
- Sponsor's protocol ID
- 823323
- Status last verified
- Mar 2020
- First submitted
- 23 Mar 2016
- Last updated
- 25 Mar 2020
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Single Shot Versus Continuous Infraclavicular Brachial Plexus Block for Postoperative Analgesia After Distal Radius Fracture: A Prospective Randomized Open Label Study
- ClinicalTrials.gov ID
- NCT02744352
- Acronym / sponsor ID
- 823323
- Keywords
- infraclavicular brachial plexus block, quality of recovery score, pain score, disability assessment of shoulder and hand questionnaire
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: prior to its planned completion as anticipated by the protocol due to lack of resources
- Enrolment
- 8 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 20 Apr 2016 (estimated)
- Results
- Posted 25 Mar 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Single shot block
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| continuous IBP block | Active comparator | Drug: 20ml bolus of 0.5% ropivicaine, Drug: 0.2% of ropivacaine at 8 milliliter/hourSubjects 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 | Drug: 20ml bolus of 0.5% ropivicaineSubjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 20ml bolus of 0.5% ropivicaineLocal anesthetic | Drug | continuous IBP block, single shot IBP block |
| 0.2% of ropivacaine at 8 milliliter/hourLocal anesthetic | Drug | continuous IBP block |
Primary outcome
Pain Scores as Measured by the Visual Analog Scale
Time frame: 72 hours
Pain scores at rest and with movement.
Participants Need for Pain Relief as Measured by Opiate Consumption
Time frame: 72 hours
Amount of opiate consumption
3 secondary outcomes
Quality of Recovery Score
Time frame: 72 hours
Number of Subjects With Insomnia as Measured by Sleep Questionnaire
Time frame: 48 hours
Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire
Time frame: 3 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Mar 2020.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nabil M Elkassabany principal investigator
University of Pennsylvania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 20ml bolus of 0.5% ropivicaine and 0.2% of ropivacaine at 8 milliliter/hour in people with Distal Radius Fracture and Post Operative Pain Control, run by University of Pennsylvania at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 25 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 25 Mar 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pain Scores as Measured by the Visual Analog Scale (time frame: 72 hours). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Mar 2020.