Superficial Cervical Plexus Blockade for Clavicle Fracture Analgesia

NCT03187899 | Withdrawn Phase 3 DMC FDA Drug

• 1 other identifier: F170512002
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

Pain, Postoperative; Satisfaction

Keywords

cervical plexus block; clavicle fracture; interscalene brachial plexus block

Outcome Measures

Primary Outcomes (1)

• Pain Score

  Average pain score from baseline to 48 hrs postoperatively

  baseline to 48 hours postoperatively

Secondary Outcomes (1)

• Patient Satisfaction

  48 hours postoperatively

Study Arms (2)

Interscalene block plus "sham"

SHAM COMPARATOR

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

Drug: Ropivacaine; Drug: Normal saline

Interscalene plus superficial plexus block

ACTIVE COMPARATOR

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

Drug: Ropivacaine

Interventions

Ropivacaine 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.

Also known as: Naropin

Interscalene block plus "sham"; Interscalene plus superficial plexus block

Normal saline DRUG

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

Also known as: sodium chloride 0.9%

Interscalene block plus "sham"

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Alabama at Birmingham: lead

Study Sites (1)

UAB Department of Anesthesiology and Perioperative Medicine

Birmingham, Alabama, 35249, United States

Location

MeSH Terms

Conditions

Pain, Postoperative; Personal Satisfaction

Interventions

Ropivacaine; Saline Solution; Sodium Chloride

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Christopher A Godlewski, MD

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, Assistant Professor

Model Details: 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.

Study Record Dates

• First Submitted: June 13, 2017
• First Posted: June 15, 2017
• Study Start: April 1, 2018
• Primary Completion: July 1, 2018
• Study Completion: December 1, 2018
• Last Updated: May 25, 2018

Record last verified: 2018-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)