Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
| Status: | Withdrawn |
|---|---|
| Conditions: | Post-Surgical Pain |
| Therapuetic Areas: | Musculoskeletal |
| Healthy: | No |
| Age Range: | 18 - 100 |
| Updated: | 5/27/2018 |
| Start Date: | April 2018 |
| End Date: | December 2018 |
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.
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.
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.
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.
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.
We found this trial at
1
site
Birmingham, Alabama 35249
Principal Investigator: Christopher Godlewski, MD
Phone: 205-934-4711
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