NCT02181296

Brief Summary

The objective of our study is to compare the degree of phrenic nerve blockade after interscalene block using 0.1% ropivacaine or 0.2% ropivacaine. Our hypothesis is that using a lower concentration of local anesthetic will result in lesser degree of phrenic nerve block. 40 patients will be enrolled. Half will receive the block with 0.1% ropivacaine and half with 0.2% ropivacaine. Phrenic nerve and diaphragm function will be assessed by bedside spirometry and ultrasound visualization.

Trial Health

100
On Track

Trial Health Score

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

Enrollment
50

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jul 2014

Status
completed

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

June 6, 2014

Completed
25 days until next milestone

Study Start

First participant enrolled

July 1, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 3, 2014

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2016

Completed
2.8 years until next milestone

Results Posted

Study results publicly available

November 2, 2018

Completed
Last Updated

February 20, 2019

Status Verified

May 1, 2018

Enrollment Period

1.6 years

First QC Date

June 6, 2014

Results QC Date

August 7, 2017

Last Update Submit

January 30, 2019

Conditions

Shoulder Arthroscopy

Keywords

Shoulder arthroscopyInterscalene blockDrug concentration0.1% ropivacaine or 0.2% ropivacaine

Outcome Measures

Primary Outcomes (1)

  • Number of Patients With Paradoxical Diaphragmatic Movement

    The primary outcome variable is the number of patients with paradoxical diaphragmatic movement ( as an indication for phrenic nerve blockade) as assessed by ultrasonographic evaluation of diaphragm

    30 minutes after the block

Secondary Outcomes (3)

  • Percentage Change of Forced Vital Capacity (FVC) From Pre-block Value to Value Measures in PACU

    within 30 minutes from arrival to PACU

  • Percentage Change in Forced Expired Volume in First Second (FEV1) After the Block

    within 30 minutes from arrival to PACU

  • Opioid Requirements for 72 Hours After Surgery

    72 hours

Study Arms (2)

High concentration group

ACTIVE COMPARATOR

0.2% ropivacaine

Drug: ropivacaine

Lower concentration group

ACTIVE COMPARATOR

0.1% ropivacaine

Drug: ropivacaine

Interventions

ropivacaineDRUG
Also known as: naropin
High concentration groupLower concentration group

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • All patients scheduled for shoulder arthroscopy
  • ASA physical status between I-III
  • Mentally competent and able to give consent for enrollment in the study -

You may not qualify if:

  • Patients who are coagulopathic or currently on anticoagulation medication (except for ASA (acetylsalicylic acid) or NSAIDS)
  • Patients with severe pulmonary disease such as asthma or COPD or substantial smoking history suggestive of COPD
  • Patients with allergy to local anesthetics or other study drugs
  • Patients with chronic opiate use
  • Patients with known dysfunction of diaphragm, intercostal muscles, or other neuromuscular disorders affecting respiration
  • Inability to speak or understand English language

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • Wong AK, Keeney LG, Chen L, Williams R, Liu J, Elkassabany NM. Effect of Local Anesthetic Concentration (0.2% vs 0.1% Ropivacaine) on Pulmonary Function, and Analgesia After Ultrasound-Guided Interscalene Brachial Plexus Block: A Randomized Controlled Study. Pain Med. 2016 Dec;17(12):2397-2403. doi: 10.1093/pm/pnw057. Epub 2016 Apr 13.

    PMID: 28025374DERIVED

MeSH Terms

Interventions

Ropivacaine

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Results Point of Contact

Title
Dr. Nabil M Elkassabany
Organization
University of Pennsylvania
Nabil.Elkassabany@uphs.upenn.edu
(215) 662-3793

Study Officials

  • Nabil Elkassabany, MD

    University of Pennsylvania, Anesthesia

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 6, 2014

First Posted

July 3, 2014

Study Start

July 1, 2014

Primary Completion

February 1, 2016

Study Completion

February 1, 2016

Last Updated

February 20, 2019

Results First Posted

November 2, 2018

Record last verified: 2018-05