NCT02970097

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.

Trial Health

30
At Risk

Trial Health Score

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

Trial has exceeded expected completion date
Timeline
Completed

Started Sep 2016

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
withdrawn

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

Study Start

First participant enrolled

September 1, 2016

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

October 24, 2016

Completed
28 days until next milestone

First Posted

Study publicly available on registry

November 21, 2016

Completed
1.9 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
Last Updated

February 21, 2020

Status Verified

February 1, 2020

Enrollment Period

2.1 years

First QC Date

October 24, 2016

Last Update Submit

February 18, 2020

Conditions

Wrist InjuriesPostoperative Pain Control

Keywords

infraclavicular brachial plexus blockwrist arthroscopyquality of recovery scorepain scoremodified sleep quality assessment

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

    7 days

  • quality of sleep as measured by modified Pittsburgh Sleep Quality Index

    72 hours

  • Range of motion as measured by the Disability assessment of shoulder and hand questionnaire

    3 months

Study Arms (2)

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% ropivicaineDrug: MidazolamDrug: 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

Drug: 10 ml of 0.5% ropivicaine

Interventions

20ml bolus of 0.5% ropivicaineDRUG

local anesthetic

Also known as: Naropin
single shot IBP block
10 ml of 0.5% ropivicaineDRUG

local anesthetic

Also known as: Naropin
local infiltration
MidazolamDRUG

1-2 mg of medication given intravenously before nerve block

Also known as: Versed
single shot IBP block
FentanylDRUG

50-100 mcg of medication given intravenously before nerve block

Also known as: Sublimaze, Actiq, Durogesic, Fentora
single shot IBP block

Eligibility Criteria

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

You may qualify if:

  • 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

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 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

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 Injuries

Interventions

RopivacaineMidazolamFentanyl

Condition Hierarchy (Ancestors)

Arm InjuriesWounds and Injuries

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAminesBenzodiazepinesBenzazepinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic CompoundsPiperidinesHeterocyclic Compounds, 1-Ring

Study Officials

  • Nabil Elkassabany, MD

    University of Pennsylvania, Anesthesia

    PRINCIPAL INVESTIGATOR
0

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

October 24, 2016

First Posted

November 21, 2016

Study Start

September 1, 2016

Primary Completion

October 5, 2018

Study Completion

October 5, 2018

Last Updated

February 21, 2020

Record last verified: 2020-02

Locations

US(1)