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Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

Primary Purpose

Pain, Postoperative, Satisfaction

Status
Withdrawn
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine
Normal saline
Sponsored by
University of Alabama at Birmingham
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Pain, Postoperative focused on measuring cervical plexus block, clavicle fracture, interscalene brachial plexus block

Eligibility Criteria

18 Years - 100 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Patients who present for repair of isolated clavicle fractures and non-/malunions that consent to regional anesthesia and to be a part of the study.

Exclusion Criteria:

  • Polytraumatized patients with multiple confounding injuries, patients who are not candidates for either block at the discretion of the Anesthesia Attending, patient refusal to participate in study, patient refusal of regional technique, patients with significant pulmonary disease that will not tolerate possible hemi-diaphragmatic paralysis at the discretion of the attending anesthesiologist.

Sites / Locations

  • UAB Department of Anesthesiology and Perioperative Medicine

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Interscalene block plus "sham"

Interscalene plus superficial plexus block

Arm Description

Patients in this group will receive a traditional interscalene block and a "sham" superficial plexus block with ropivacaine and 5-10cc of normal saline. N = 20

Patients in this group will receive a traditional interscalene block and a superficial plexus block with ropivacaine . N = 20

Outcomes

Primary Outcome Measures

Pain Score
Average pain score from baseline to 48 hrs postoperatively

Secondary Outcome Measures

Patient Satisfaction
Patient satisfaction score at 48 hours postoperatively

Full Information

First Posted
June 13, 2017
Last Updated
May 23, 2018
Sponsor
University of Alabama at Birmingham
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1. Study Identification

Unique Protocol Identification Number
NCT03187899
Brief Title
Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
Official Title
Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Principal investigator was unable to pursue research further due to time constraints.
Study Start Date
April 2018 (Anticipated)
Primary Completion Date
July 2018 (Anticipated)
Study Completion Date
December 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Alabama at Birmingham

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The goal of the study is to determine if the addition of a superficial cervical plexus block to a traditional interscalene plexus block will provide superior perioperative analgesia to an interscalene brachial plexus blockade alone for repair of clavicle fractures and non-/malunions.
Detailed Description
When patients that are possible participants in the study present for surgery, they will be offered the opportunity to participate in the trial as part of the informed consent process. Should they agree to participate, they will be randomized to receive either an interscalene + "sham" superficial cervical plexus block or an interscalene + superficial cervical plexus block. The randomization will have already been predetermined based off of envelopes that will have been created by a research assistant. Within the envelopes the proper paperwork needed to consent a participant along with a label that will be labeled either interscalene + sham superficial cervical plexus block or interscalene + superficial cervical plexus block. This will assign the randomization of each participant (this will be unknown to all study personnel until identified by the label). Their pain scores will be assessed pre-operatively as well as post-operatively .. If they are admitted to the hospital, the PI and/or Co-Investigators will assess their pain scores on a daily basis and follow-up with a phone call to assess their satisfaction with the block. Numerical pain scores (scale of 0-10) will be used to assess post-operative pain with 0 indicating no pain and 10 indicating severe pain. Post-operative pain will be assessed by compiling pain scores from 2 different sources: Numerical pain scores recorded by nursing staff (vitals section of EMR) and also pain scores ascertained by residents during rounds (progress notes). For each pain score, we will record the date and time it was obtained. If they are discharged the same day as surgery, they will receive a phone call within 48 hours to assess their pain scale and satisfaction. We will also assess nausea and vomiting, the amount and type of pain medicine they are taking, and assess if they could tell when their block wore off.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Pain, Postoperative, Satisfaction
Keywords
cervical plexus block, clavicle fracture, interscalene brachial plexus block

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Participants will be randomized to receive either an interscalene brachial plexus block plus sham superficial cervical plexus block or an interscalene brachial plexus block plus a superficial cervical plexus block. The patient will be blinded as to which block they receive to prevent bias. The Attending performing/overseeing the block will not be blinded to which block is being performed. Patients receiving a traditional interscalene block and a "sham" superficial plexus block with 5-10cc of normal saline N = 20. Patients group receiving both an interscalene and a superficial plexus block N = 20.
Masking
Participant
Masking Description
The patient will be blinded as to which block they receive to prevent bias. The Attending performing/overseeing the block will not be blinded to which block is being performed.
Allocation
Randomized
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Interscalene block plus "sham"
Arm Type
Sham Comparator
Arm Description
Patients in this group will receive a traditional interscalene block and a "sham" superficial plexus block with ropivacaine and 5-10cc of normal saline. N = 20
Arm Title
Interscalene plus superficial plexus block
Arm Type
Active Comparator
Arm Description
Patients in this group will receive a traditional interscalene block and a superficial plexus block with ropivacaine . N = 20
Intervention Type
Drug
Intervention Name(s)
Ropivacaine
Other Intervention Name(s)
Naropin
Intervention Description
0.5% of Ropivacaine will be used patients in both groups. Ropivacaine is very common in the investigator's practice of regional anesthesia. The investigator has experienced minimal adverse effects with 0.5% Ropivacaine used in volume suggested in our study.
Intervention Type
Drug
Intervention Name(s)
Normal saline
Other Intervention Name(s)
sodium chloride 0.9%
Intervention Description
5-10cc of Normal Saline will be given to patients receiving a traditional interscalene block and a sham superficial plexus block.
Primary Outcome Measure Information:
Title
Pain Score
Description
Average pain score from baseline to 48 hrs postoperatively
Time Frame
baseline to 48 hours postoperatively
Secondary Outcome Measure Information:
Title
Patient Satisfaction
Description
Patient satisfaction score at 48 hours postoperatively
Time Frame
48 hours postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
100 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Patients who present for repair of isolated clavicle fractures and non-/malunions that consent to regional anesthesia and to be a part of the study. Exclusion Criteria: Polytraumatized patients with multiple confounding injuries, patients who are not candidates for either block at the discretion of the Anesthesia Attending, patient refusal to participate in study, patient refusal of regional technique, patients with significant pulmonary disease that will not tolerate possible hemi-diaphragmatic paralysis at the discretion of the attending anesthesiologist.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christopher A Godlewski, MD
Organizational Affiliation
University of Alabama at Birmingham
Official's Role
Principal Investigator
Facility Information:
Facility Name
UAB Department of Anesthesiology and Perioperative Medicine
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

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Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

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