Bupivacaine Versus Ropivacaine on Diaphragmatic Motility and Ventilatory Function

NCT02059070 | Completed Results DMC

• 1 other identifier: 050412M1F
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Outpatient continuous interscalene brachial plexus blocks are used to control pain after shoulder surgery, with infusions of 0.125% bupivacaine or 0.2% ropivacaine. There have been no studies comparing the effects of these two formulations. The major concern is hemidiaphragmatic paresis, and since ropivacaine preferentially blocks sensory fibers, it may cause less blockade of the phrenic nerve. This study was to evaluate the effects of continuous interscalene brachial plexus infusions, with the hypothesis that respiratory function is more affected by 0.125% bupivacaine than 0.2% ropivacaine, with equal effects on pain relief. Methods: All patients underwent baseline spirometry and ultrasound evaluation of diaphragmatic excursion, followed by interscalene catheter placement for their surgery, then randomized to receive a pump containing 0.2% ropivacaine or 0.125% bupivacaine. Patients returned to the hospital the following day for spirometry, ultrasound reevaluation, and evaluation of their pain level since discharge.

Conditions

Paresis

Keywords

Nerve Block/adverse effects; Phrenic Nerve; Respiratory function; Pain measurement

Outcome Measures

Primary Outcomes (1)

• Forced Expiratory Volume at 1 Second (% Change From Baseline)

  Within the first 4 days following surgery

Secondary Outcomes (2)

• Ultrasonographic Evaluation of Diaphragmatic Excursion- Operative Side Sigh Test

  Within 36hrs following surgery

• Post-operative Oxycodone Use (mg)

  The 24 hour period following surgery

Other Outcomes (1)

• Highest Patient Pain Level

  Within 36 hours of surgery

Study Arms (2)

0.125% Bupivacaine

EXPERIMENTAL

Group 1) Post-operative 0.125% Bupivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

Drug: Bupivacaine

0.2% Ropivacaine

EXPERIMENTAL

Group 2) Post-operative 0.2% Ropivacaine Interscalene brachial plexus block, 6ml/hr, continuous.

Drug: Ropivacaine

Interventions

Ropivacaine DRUG

Post-operative epidural 0.125% Ropivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.

Also known as: Naropin

0.2% Ropivacaine

Bupivacaine DRUG

Post-operative epidural 0.125% Bupivacaine Interscalene brachial plexus block, 20-28 hrs post surgery.

Also known as: Marcaine

0.125% Bupivacaine

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing shoulder surgery
• Patients must be willing to give written informed consent
• Patients must be able and willing to return to hospital on the first postoperative day for study follow-up procedures
• Patients must have a working phone number where they can be reached daily after surgery

You may not qualify if:

• Patients who do not receive an interscalene catheter for their respective surgery for any reason
• Patients that received an interscalene catheter, but had any surgical or catheter adverse events prior to discharge
• Patients with a history of adverse reactions to either study drug
• Patients with a history of contralateral phrenic nerve paralysis,
• Patients with a history of extensive prior lung surgery on either lung.
• Patients with a history of decreased pulmonary function
• Any emergent cases

Sponsors & Collaborators

• Anesthesiology WSU/DMC-NorthStar: lead
• Wayne State University: collaborator

Study Sites (1)

DMC Surgery Hospital

Madison Heights, Michigan, 48071, United States

Location

MeSH Terms

Conditions

Paresis; Respiratory Aspiration

Interventions

Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Respiration Disorders; Respiratory Tract Diseases; Pathologic Processes

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Results Point of Contact

• Title: Pranav Patel
• Organization: Wayne State University, School of Medicine

gmckelve@dmc.org

313-745-7233

Study Officials

• Pranav Patel, M.D.

  Wayne State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: January 10, 2014
• First Posted: February 11, 2014
• Study Start: June 1, 2012
• Primary Completion: January 1, 2013
• Study Completion: June 1, 2013
• Last Updated: November 25, 2014
• Results First Posted: September 30, 2014

Record last verified: 2014-11

Locations

US (1)