Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Erector Spinae Plane Block Versus Paravertebral Block

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03471442
Recruitment Status : Recruiting
First Posted : March 20, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Derek Dillane, University of Alberta

Brief Summary:

This study aims to compare the effectiveness of paravertebral block and erector spinae plane block after mastectomy.

The primary objective of this randomized controlled trial is to demonstrate equivalent dermatomal spread for ultrasound-guided single-injection Erector Spinae Plane (ESP) block performed at T4-T5 level and ultrasound-guided single-injection (paravertebral) PVB block at the same level.

Secondary objectives are Numerical Rating Scale (NRS) pain scores in the first 24 post-operative hours, opioid analgesia use intra-operatively and in the first 24 post-operative hours, block procedural time and patient discomfort during block insertion.

The investigators hypothesize that ESP block efficacy is not inferior to PVB with reference to dermatomal sensory spread and analgesic efficacy, while being easier to perform with less associated discomfort during block insertion.


Condition or disease Intervention/treatment Phase
Breast Cancer Pain, Postoperative Anesthesia, Local Procedure: Paravertebral block Procedure: Erector spinae plane block Drug: General anesthetic Drug: Opioids Drug: Anesthetics, Local Not Applicable

  Show Detailed Description

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 42 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Erector Spinae Plane Block Versus Paravertebral Block in Patients Undergoing Elective Breast Surgery. A Randomized Controlled Trial Comparing Dermatomal Spread.
Actual Study Start Date : February 20, 2018
Estimated Primary Completion Date : August 1, 2019
Estimated Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Paravertebral
Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.
Procedure: Paravertebral block
Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Drug: General anesthetic
General anesthesia administered as per preference of intra-operative attending anesthesiologist

Drug: Opioids
Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone. Post-operatively in post anesthesia care unit, morphine and hydromorphone will be titrated to effect as necessary. After discharge from post anesthesia care unit, oral analgesia will be administered on an as required basis e.g. acetaminophen, non-steroid anti-inflammatory medications, acetaminophen / codeine and acetaminophen / oxycodone.

Drug: Anesthetics, Local
Weight-based dosing of this local anesthetic mixture.
Other Name: Ropivacaine / bupivacaine mixture to a final concentration of 0.125% bupivacaine and 0.5% ropivacaine

Experimental: Erector spinae plane
Ultrasound-guided erector spinae plane block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.
Procedure: Erector spinae plane block
Ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Drug: General anesthetic
General anesthesia administered as per preference of intra-operative attending anesthesiologist

Drug: Opioids
Intra-operatively, opioids will be titrated to heart rate and spontaneous respiration rate e.g. fentanyl, morphine, hydromorphone. Post-operatively in post anesthesia care unit, morphine and hydromorphone will be titrated to effect as necessary. After discharge from post anesthesia care unit, oral analgesia will be administered on an as required basis e.g. acetaminophen, non-steroid anti-inflammatory medications, acetaminophen / codeine and acetaminophen / oxycodone.

Drug: Anesthetics, Local
Weight-based dosing of this local anesthetic mixture.
Other Name: Ropivacaine / bupivacaine mixture to a final concentration of 0.125% bupivacaine and 0.5% ropivacaine




Primary Outcome Measures :
  1. Dermatomal spread of sensory blockade [ Time Frame: 30 minutes ]
    Assessment of extent of sensory block by pinprick


Secondary Outcome Measures :
  1. Numerical Rating Scale (NRS) for pain [ Time Frame: Up to 24 hours ]
    Subjective pain score between 0 (no pain) and 10 (worst possible pain) immediately post-operatively at 6, 12 and 24 hours

  2. Opioid analgesia use intra-operatively [ Time Frame: 1 to 3 hours ]
    Amount of opioid administered by the intra-operative anesthesiologist

  3. Total opioid use in the first 24 hours [ Time Frame: Up to 24 hours ]
    Amount of opioid used by patient in the first 24 hours after surgery

  4. Block procedural time [ Time Frame: Up to 30 Minutes ]
    Amount of time it takes to perform the block procedure starting with when the ultrasound image is acquired and finishing when all of the local anesthetic has been injected



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Adult patients over 18 years
  • Consented to a regional anesthesia technique for post-operative analgesia
  • Partial or complete mastectomy

Exclusion Criteria:

  • Subjects <18 years
  • those who refuse consent for PVB or ESP blockade,
  • opioid tolerant patients
  • psychiatric illness
  • allergy to local anesthetic
  • Local or systemic infection

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03471442


Contacts
Layout table for location contacts
Contact: Derek Dillane, FCARCSI 7804071303 dillane@ualberta.ca
Contact: Michelle Verrier 7804078600 mrheault@ualberta.ca

Locations
Layout table for location information
Canada, Alberta
University of Alberta Recruiting
Edmonton, Alberta, Canada, T6G 2B7
Contact: Derek Dillane, FCARCSI    7804071303    dillane@ualberta.ca   
Sub-Investigator: Rakesh Sondekoppam, MD         
Sub-Investigator: James Green, MB FRCA         
Sub-Investigator: Susan Halliday, MB FRCA         
Sponsors and Collaborators
University of Alberta

Publications:

Layout table for additonal information
Responsible Party: Derek Dillane, Associate professor, University of Alberta
ClinicalTrials.gov Identifier: NCT03471442     History of Changes
Other Study ID Numbers: Pro00078230
First Posted: March 20, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
Layout table for MeSH terms
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Analgesics, Opioid
Bupivacaine
Ropivacaine
Anesthetics, Local
Anesthetics
Anesthetics, General
Central Nervous System Depressants
Physiological Effects of Drugs
Sensory System Agents
Peripheral Nervous System Agents
Narcotics
Analgesics