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Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair

Primary Purpose

Distal Radius Fracture, Post Operative Pain Control

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
20ml bolus of 0.5% ropivicaine
0.2% of ropivacaine at 8 milliliter/hour
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Distal Radius Fracture focused on measuring infraclavicular brachial plexus block, quality of recovery score, pain score, disability assessment of shoulder and hand questionnaire

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

continuous IBP block

single shot IBP block

Arm Description

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

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

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
Number of Subjects With Insomnia as Measured by Sleep Questionnaire
Quality of sleep first 2 nights post surgery
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

First Posted
March 23, 2016
Last Updated
March 24, 2020
Sponsor
University of Pennsylvania
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1. Study Identification

Unique Protocol Identification Number
NCT02744352
Brief Title
Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Terminated
Why Stopped
prior to its planned completion as anticipated by the protocol due to lack of resources
Study Start Date
October 2016 (Actual)
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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Distal Radius Fracture, Post Operative Pain Control
Keywords
infraclavicular brachial plexus block, quality of recovery score, pain score, disability assessment of shoulder and hand questionnaire

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
8 (Actual)

8. Arms, Groups, and Interventions

Arm Title
continuous IBP block
Arm Type
Active Comparator
Arm Description
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
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
Intervention Type
Drug
Intervention Name(s)
20ml bolus of 0.5% ropivicaine
Intervention Description
Local anesthetic
Intervention Type
Drug
Intervention Name(s)
0.2% of ropivacaine at 8 milliliter/hour
Intervention Description
Local anesthetic
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
72 hours
Title
Number of Subjects With Insomnia as Measured by Sleep Questionnaire
Description
Quality of sleep first 2 nights post surgery
Time Frame
48 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 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nabil M Elkassabany
Organizational Affiliation
University of Pennsylvania
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

Plan to Share IPD
No

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Single Shot vs Catheter Infraclavicular Brachial Plexus Block After Distal Radius Fracture Repair

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