Wrist InjuriesNCT02970097
Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
A study testing 20ml bolus of 0.5% ropivicaine, 10 ml of 0.5% ropivicaine and Midazolam in people with Wrist Injuries and Postoperative 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 local infiltration done in adult patients having wrist arthroscopy surgery. Visual analogue scores, opioid consumption, quality of recovery and quality of sleep up to 72 hours post operatively will be used for comparison. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Wrist Injuries, Postoperative Pain Control
- What is being tested?
- 20ml bolus of 0.5% ropivicaine, 10 ml of 0.5% ropivicaine and Midazolam
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2016to 5 Oct 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 wrist arthroscopy
- 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 light 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 Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study
The purpose of this study is to compare infraclavicular brachial plexus shot single shot block to local infiltration done in adult patients having wrist arthroscopy surgery. 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
- Local Infiltration
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 local infiltration 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 local infiltration: At the end of surgery, surgeon will inject 10 ml of Ropivacaine 0.5% into the arthroscopy portals and the wrist. Specifically, 1 ml to 2 ml of Ropivacaine 0.5% will be injected into each portal with the remainder of the volume injected into the joint space itself.
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.
- Conditions
- Wrist Injuries, Postoperative Pain Control
- Keywords
- infraclavicular brachial plexus block, wrist arthroscopy, quality of recovery score, pain score, modified sleep quality assessment
- Medical subject headings
- Wrist Injuries
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
Also called Naropin
local anesthetic
10 ml of 0.5% ropivicaineDrug
Also called Naropin
local anesthetic
MidazolamDrug
Also called Versed
1-2 mg of medication given intravenously before nerve block
FentanylDrug
Also called Sublimaze, Actiq, Durogesic, Fentora
50-100 mcg of medication given intravenously before nerve block
| Study group | Role | What they receive |
|---|---|---|
| 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; Drug: Midazolam; Drug: Fentanyl |
| local infiltration | Active comparator | Subjects will receive local infiltration into portal space and joint space with 10ml of 0.5% ropivicaine given intraoperatively to help with operative and postoperative pain Receives: Drug: 10 ml 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: 7 days
quality of sleep as measured by modified Pittsburgh Sleep Quality Index
a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3
Measured: 72 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 posted21 Nov 2016 (estimated)
- Study startSep 2016
- Primary completion5 Oct 2018
- Study completion5 Oct 2018
Why it stopped: lack of resources
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Wrist InjuriesStudies 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
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pennsylvania
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nabil Elkassabany, MD, Principal investigator, University of Pennsylvania, Anesthesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02970097
- Sponsor's protocol ID
- 825465
- Status last verified
- Feb 2020
- First submitted
- 24 Oct 2016
- Last updated
- 21 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study
- ClinicalTrials.gov ID
- NCT02970097
- Acronym / sponsor ID
- 825465
- Conditions
- Wrist Injuries, Postoperative Pain Control
- Keywords
- infraclavicular brachial plexus block, wrist arthroscopy, quality of recovery score, pain score, modified sleep quality assessment
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: lack of resources
- Enrolment
- 0 participants (actual)
- Lead sponsor
- University of PennsylvaniaUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- 5 Oct 2018 (actual)
- Study completion
- 5 Oct 2018 (actual)
- First posted
- 21 Nov 2016 (estimated)
- Results
- Not posted in the source record
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 local infiltration done in adult patients having wrist arthroscopy surgery. 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
- Local Infiltration
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 local infiltration 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 local infiltration: At the end of surgery, surgeon will inject 10 ml of Ropivacaine 0.5% into the arthroscopy portals and the wrist. Specifically, 1 ml to 2 ml of Ropivacaine 0.5% will be injected into each portal with the remainder of the volume injected into the joint space itself.
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 |
|---|---|---|
| single shot IBP block | Active comparator | Drug: 20ml bolus of 0.5% ropivicaine, Drug: Midazolam, Drug: FentanylSubjects will receive single shot infraclavicular brachial plexus block with 20ml bolus of 0.5% ropivicaine given preoperatively to help with operative and postoperative pain |
| local infiltration | Active comparator | Drug: 10 ml of 0.5% ropivicaineSubjects will receive local infiltration into portal space and joint space with 10ml of 0.5% ropivicaine given intraoperatively 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 wrist arthroscopy
- 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 light 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% ropivicaineAlso: Naropinlocal anesthetic | Drug | single shot IBP block |
| 10 ml of 0.5% ropivicaineAlso: Naropinlocal anesthetic | Drug | local infiltration |
| MidazolamAlso: Versed1-2 mg of medication given intravenously before nerve block | Drug | single shot IBP block |
| FentanylAlso: Sublimaze, Actiq, Durogesic, Fentora50-100 mcg of medication given intravenously before nerve block | Drug | single shot 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: 7 days
quality of sleep as measured by modified Pittsburgh Sleep Quality Index
Time frame: 72 hours
Range of motion as measured by the Disability assessment of shoulder and hand questionnaire
Time frame: 3 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 2020.
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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 Elkassabany, MD principal investigator
University of Pennsylvania, Anesthesia
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, 10 ml of 0.5% ropivicaine and Midazolam in people with Wrist Injuries and Postoperative 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: withdrawn, as of the sponsor's last update on 21 Feb 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?
The study was withdrawn before enrolling participants, so there are no results.
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 21 Feb 2020.