Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

NCT ID: NCT03187899

Last Updated: 2018-05-25

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: PHASE3
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-04-30
• Study Completion Date: 2018-12-31

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.

Conditions

Pain, Postoperative; Satisfaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Interscalene block plus "sham"

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

Group Type: SHAM_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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.

Normal saline

Intervention Type: DRUG

5-10cc of Normal Saline will be given to patients receiving a traditional interscalene block and a sham superficial plexus block.

Interscalene plus superficial plexus block

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

Group Type: ACTIVE_COMPARATOR

Ropivacaine

Intervention Type: DRUG

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.

Interventions

Ropivacaine

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

Normal saline

5-10cc of Normal Saline will be given to patients receiving a traditional interscalene block and a sham superficial plexus block.

Intervention Type: DRUG

Other Intervention Names

Naropin; sodium chloride 0.9%

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Alabama at Birmingham

OTHER

Sponsor Role: lead

Responsible Party

Christopher Godlewski

MD, Assistant Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Christopher A Godlewski, MD

Role: PRINCIPAL_INVESTIGATOR

University of Alabama at Birmingham

Locations

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, United States

Countries

United States

Other Identifiers

F170512002

Identifier Type: -

Identifier Source: org_study_id