Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia
- Conditions
- Pain, PostoperativeSatisfaction
- Interventions
- Drug: Normal saline
- Registration Number
- NCT03187899
- Lead Sponsor
- University of Alabama at Birmingham
- 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.
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Interscalene block plus "sham" Normal saline 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 Interscalene block plus "sham" Ropivacaine 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 Interscalene plus superficial plexus block Ropivacaine Patients in this group will receive a traditional interscalene block and a superficial plexus block with ropivacaine . N = 20
- Primary Outcome Measures
Name Time Method Pain Score baseline to 48 hours postoperatively Average pain score from baseline to 48 hrs postoperatively
- Secondary Outcome Measures
Name Time Method Patient Satisfaction 48 hours postoperatively Patient satisfaction score at 48 hours postoperatively
Trial Locations
- Locations (1)
UAB Department of Anesthesiology and Perioperative Medicine
🇺🇸Birmingham, Alabama, United States