Clinical trial NCT03187899: Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
Official title: Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Pain, Postoperative
Satisfaction
Keywords: cervical plexus block
clavicle fracture
interscalene brachial plexus block
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
First posted: 2017-06-15
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 100
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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.
Primary purpose: PREVENTION

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.

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.

Primary outcomes:
measure: Pain Score
timeFrame: baseline to 48 hours postoperatively
Secondary outcomes:
measure: Patient Satisfaction
timeFrame: 48 hours postoperatively
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: UAB Department of Anesthesiology and Perioperative Medicine
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Christopher A Godlewski, MD
role: PRINCIPAL_INVESTIGATOR
References: