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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
Results First Posted : July 24, 2020
Last Update Posted : July 24, 2020
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

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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 Scores [ Time Frame: 1 day (PACU pain scores) ]
    Range scale minimum 0, maximum 10. Lower pain scores are considered a better outcome, higher pain scores are considered a worse outcome.

  2. OR and PACU Opioid Consumption [ Time Frame: up to 1 day, in the OR and PACU ]
    This outcome measure reflects the total amount of opioid administered in the operating room and recovery room perioperatively. Specific time points are not applicable since operating room and recovery room times differ among subjects.


Other Outcome Measures:
  1. Nausea and Vomiting [ Time Frame: postoperative day 1 ]
    Nausea and vomiting was recorded using a 0-10 Likert scale (0 = no nausea; 10 = vomiting) on postoperative day 1. Higher scores represent a worse outcome.

  2. Sleep Disturbances [ Time Frame: postoperative day 1 ]
  3. Time of Block Resolution [ Time Frame: postoperative day 1 ]
    This was recorded as the time at which a participant subjectively noticed that the nerve block was wearing off and sensation was returning.

  4. Opioid Consumption [ Time Frame: postoperative day 1 ]
    Number of oxycodone tablets (in mg) taken by the participant after discharge from the recovery room was recorded during follow-up on postoperative day 1.



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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
  Study Documents (Full-Text)

Documents provided by Brian M. Ilfeld, MD, MS, University of California, San Diego:
Informed Consent Form  [PDF] June 21, 2018

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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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    
Other Study ID Numbers: Erector Spinae vs PVB
First Posted: June 7, 2018    Key Record Dates
Results First Posted: July 24, 2020
Last Update Posted: July 24, 2020
Last Verified: July 2020
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