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Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery

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ClinicalTrials.gov Identifier: NCT03549234
Recruitment Status : Completed
First Posted : June 7, 2018
Last Update Posted : May 13, 2019
Sponsor:
Information provided by (Responsible Party):
Brian M. Ilfeld, MD, MS, University of California, San Diego

Brief Summary:

Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitations: it can decrease blood pressure, and very rare—but serious—complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin: there are few anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB.

There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.


Condition or disease Intervention/treatment Phase
Breast Surgery Drug: Erector Spinae (single injection) Drug: Paravertebral (single injection) Phase 4

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Treatment
Official Title: A Randomized, Subject-Masked, Active-Controlled, Parallel-Arm Clinical Trial Comparing Erector Spinae and Paravertebral Nerve Blocks
Actual Study Start Date : July 12, 2018
Actual Primary Completion Date : May 8, 2019
Actual Study Completion Date : May 8, 2019

Arm Intervention/treatment
Experimental: Erector Spinae (single injection) Drug: Erector Spinae (single injection)
Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.

Active Comparator: Paravertebral (single injection) Drug: Paravertebral (single injection)
Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.




Primary Outcome Measures :
  1. Numeric Rating Scale pain score, opioid consumption [ Time Frame: 1 day ]
    Numeric Rating Scale: the NRS is a segmented numeric version of the Visual Analog Scale (VAS) in which the study subject selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. This 11-point numeric scale ranges from 0 representing "no pain" to 10 representing "worst imaginable pain." Higher numeric scores represent increased pain and thus worse outcomes.


Other Outcome Measures:
  1. Nausea and vomiting [ Time Frame: 1 day ]
  2. Sleep disturbances [ Time Frame: 1 day ]
  3. Time of block resolution [ Time Frame: 1 day ]
  4. Opioid consumption [ Time Frame: 1 day ]


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

Inclusion Criteria:

  • undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated
  • analgesic plan includes a single-injection peripheral nerve block(s)
  • age 18 years or older.

Exclusion Criteria:

  • morbid obesity as defined by a body mass index > 40 (BMI=weight in kg / [height in meters]2)
  • renal insufficiency (preoperative creatinine > 1.5 mg/dL)
  • chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use > 4 weeks)
  • history of opioid abuse
  • any comorbidity which results in moderate or severe functional limitation
  • inability to communicate with the investigators or hospital staff
  • pregnancy
  • planned regional analgesic with perineural catheter placement
  • incarceration

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): NCT03549234


Locations
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United States, California
UCSD Medical Center (Hillcrest and Thornton)
San Diego, California, United States, 92103
Sponsors and Collaborators
University of California, San Diego
Investigators
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Principal Investigator: Brian M Ilfeld, MD MS Professor in Residence

Publications:

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Responsible Party: Brian M. Ilfeld, MD, MS, Professor of Anesthesiology, In Residence, University of California, San Diego
ClinicalTrials.gov Identifier: NCT03549234     History of Changes
Other Study ID Numbers: Erector Spinae vs PVB
First Posted: June 7, 2018    Key Record Dates
Last Update Posted: May 13, 2019
Last Verified: May 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes

Keywords provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Regional anesthesia
Paravertebral
Erector spinae
Nerve block