NCT02744352

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

April 20, 2016

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2016

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 5, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 5, 2018

Completed
1.5 years until next milestone

Results Posted

Study results publicly available

March 25, 2020

Completed
Last Updated

March 25, 2020

Status Verified

March 1, 2020

Enrollment Period

2 years

First QC Date

March 23, 2016

Results QC Date

March 6, 2020

Last Update Submit

March 24, 2020

Conditions

Distal Radius FracturePost Operative Pain Control

Keywords

infraclavicular brachial plexus blockquality of recovery scorepain scoredisability assessment of shoulder and hand questionnaire

Outcome Measures

Primary Outcomes (2)

  • 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

Secondary Outcomes (3)

  • Quality of Recovery Score

    72 hours

  • Number of Subjects With Insomnia as Measured by Sleep Questionnaire

    48 hours

  • Range of Motion as Measured by the Disability Assessment of Shoulder and Hand Questionnaire

    3 months

Study Arms (2)

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

Drug: 20ml bolus of 0.5% ropivicaineDrug: 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

Drug: 20ml bolus of 0.5% ropivicaine

Interventions

20ml bolus of 0.5% ropivicaineDRUG

Local anesthetic

continuous IBP blocksingle shot IBP block
0.2% of ropivacaine at 8 milliliter/hourDRUG

Local anesthetic

continuous IBP block

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Wrist Fractures

Condition Hierarchy (Ancestors)

Wrist InjuriesArm InjuriesWounds and InjuriesFractures, Bone

Results Point of Contact

Title
Anmol Madaan, Clinical Research Coordinator
Organization
University of Pennsylvania
Anmol.Madaan@Pennmedicine.Upenn.edu
2156623778

Study Officials

  • Nabil M Elkassabany

    University of Pennsylvania

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 23, 2016

First Posted

April 20, 2016

Study Start

October 1, 2016

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

March 25, 2020

Results First Posted

March 25, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)