Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
Primary Purpose
Wrist Injuries, Postoperative Pain Control
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
20ml bolus of 0.5% ropivicaine
10 ml of 0.5% ropivicaine
Midazolam
Fentanyl
Sponsored by
About this trial
This is an interventional treatment trial for Wrist Injuries focused on measuring infraclavicular brachial plexus block, wrist arthroscopy, quality of recovery score, pain score, modified sleep quality assessment
Eligibility Criteria
Inclusion Criteria:
- 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
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 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
Sites / Locations
- University of Pennsylvania
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
single shot IBP block
local infiltration
Arm Description
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
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
Outcomes
Primary Outcome Measures
Pain Scores as measured by the Visual Analog Scale
Pain scores at rest and with movement.
Participants need for pain relief as measured by opiate consumption
Amount of opiate consumption
Secondary Outcome Measures
Quality of recovery score
Score of QoR survey to determine recovery status
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
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
Full Information
NCT ID
NCT02970097
First Posted
October 24, 2016
Last Updated
February 18, 2020
Sponsor
University of Pennsylvania
1. Study Identification
Unique Protocol Identification Number
NCT02970097
Brief Title
Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
Official Title
Comparison Between Infraclavicular Brachial Plexus Block Versus Local Infiltration for Postoperative Analgesia After Wrist Arthroscopy, a Prospective Randomized Open Label Study
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Withdrawn
Why Stopped
lack of resources
Study Start Date
September 2016 (undefined)
Primary Completion Date
October 5, 2018 (Actual)
Study Completion Date
October 5, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Wrist Injuries, Postoperative Pain Control
Keywords
infraclavicular brachial plexus block, wrist arthroscopy, quality of recovery score, pain score, modified sleep quality assessment
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
single shot IBP block
Arm Type
Active Comparator
Arm Description
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
Arm Title
local infiltration
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
20ml bolus of 0.5% ropivicaine
Other Intervention Name(s)
Naropin
Intervention Description
local anesthetic
Intervention Type
Drug
Intervention Name(s)
10 ml of 0.5% ropivicaine
Other Intervention Name(s)
Naropin
Intervention Description
local anesthetic
Intervention Type
Drug
Intervention Name(s)
Midazolam
Other Intervention Name(s)
Versed
Intervention Description
1-2 mg of medication given intravenously before nerve block
Intervention Type
Drug
Intervention Name(s)
Fentanyl
Other Intervention Name(s)
Sublimaze, Actiq, Durogesic, Fentora
Intervention Description
50-100 mcg of medication given intravenously before nerve block
Primary Outcome Measure Information:
Title
Pain Scores as measured by the Visual Analog Scale
Description
Pain scores at rest and with movement.
Time Frame
72 hours
Title
Participants need for pain relief as measured by opiate consumption
Description
Amount of opiate consumption
Time Frame
72 hours
Secondary Outcome Measure Information:
Title
Quality of recovery score
Description
Score of QoR survey to determine recovery status
Time Frame
7 days
Title
quality of sleep as measured by modified Pittsburgh Sleep Quality Index
Description
a 9-question survey in which patients report how often sleep-related problems occur on a scale of 0 to 3
Time Frame
72 hours
Title
Range of motion as measured by the Disability assessment of shoulder and hand questionnaire
Description
Dash questionnaire to measure range of motion of the wrist and fingers 3 months after surgery
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil Elkassabany, MD
Organizational Affiliation
University of Pennsylvania, Anesthesia
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
12. IPD Sharing Statement
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Single Shot Infraclavicular Brachial Plexus Block vs Local Infiltration After Wrist Arthroscopy Surgery
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