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Erector Spinae Plane Block Versus Paravertebral Block

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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

Tracking Information
First Submitted Date  ICMJE March 1, 2018
First Posted Date  ICMJE March 20, 2018
Last Update Posted Date March 20, 2018
Actual Study Start Date  ICMJE February 20, 2018
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
Dermatomal spread of sensory blockade [ Time Frame: 30 minutes ]
Assessment of extent of sensory block by pinprick
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: March 19, 2018)
  • 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
  • Opioid analgesia use intra-operatively [ Time Frame: 1 to 3 hours ]
    Amount of opioid administered by the intra-operative anesthesiologist
  • 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
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Erector Spinae Plane Block Versus Paravertebral Block
Official Title  ICMJE Erector Spinae Plane Block Versus Paravertebral Block in Patients Undergoing Elective Breast Surgery. A Randomized Controlled Trial Comparing Dermatomal Spread.
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.

Detailed Description

Paravertebral block (PVB) has been shown to provide excellent analgesia for major breast surgery. Advantages of a PVB technique include reduced postoperative pain, analgesic consumption, opioid-related side effects, and shorter post anesthesia care unit (PACU) stay. There is also evidence to suggest that PVB may have a favorable impact on cancer recurrence after mastectomy. Paravertebral blockade results in somatosensory and sympathetic blockade after injection of local anesthetic solution to the paravertebral space posterior to the pleura. Erector spinae plane (ESP) block is a recently described technique which may be an alternative to PVB for providing thoracic analgesia. Numerous case reports and case series describe ESP block for the management of acute and chronic thoracic pain. It involves injection of local anesthetic into the fascial plane deep to erector spinae muscle. Radiological imaging in a cadaver model has demonstrated that a single injection at the level of the T5 transverse process produced cranio-caudal spread between C7 and T8. This accounts for the extensive sensory block that has been observed in case reports and is at least as extensive as the spread seen with PVB.

ESP is a more superficial block with a better defined end-point - injection between the bony transverse process and erector spinae muscle. A more superficial ultrasound-guided block will be faster to perform and less painful for the patient. Furthermore, ESP does not have the same risk of pneumothorax as PVB.There have been no randomized controlled trials involving ESP to date. All descriptions of the technique have been in case report / series format.

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, has less associated discomfort and fewer complication risks.

All eligible participants will be randomized to the PVB arm or the ESP arm after fully informed consent has been obtained. Subjects randomized to the PVB arm will have an ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Subjects randomized to the ESP arm will have an ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture. Conduct of intra-operative anesthesia will be at the discretion of the attending anesthesiologist.

The primary outcome is equivalent dermatomal spread for ultrasound-guided single-injection ESP block performed at T4-T5 level and ultrasound-guided single-injection PVB block at the same level.

Secondary outcomes are 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 primary outcome will be collected by a research associate who is blinded to the study group allocation. The secondary outcomes will be collected by the study team from the patient chart and through patient interview. Continuous variables will be analyzed using t-tests and categorical variables will be analyzed using chi-squared test. Markers of intervention safety will be monitored included local anesthetic toxicity, nerve injury, infection and pneumothorax.

A test of equivalence will be performed for the primary outcome of dermatomal spread between the 2 groups. If the equivalence is not established for the block extent, a 2-way superiority will be conducted. Secondary outcomes will be analyzed using Mann-Whitney U test and the Hodges-Lehmann method for calculating 95% confidence intervals (CIs) around the median difference. This is designed as a non-inferiority trial. Assuming a median difference of 1.5 dermatomal segments, and a pooled standard deviation (SD) of 1.65 segments, α of 0.05, and 90% power, a total sample size of 42 patients is estimated (21 patients in each group).

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Breast Cancer
  • Pain, Postoperative
  • Anesthesia, Local
Intervention  ICMJE
  • Procedure: Paravertebral block
    Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room 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
Study Arms  ICMJE
  • Active Comparator: Paravertebral
    Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.
    Interventions:
    • Procedure: Paravertebral block
    • Drug: General anesthetic
    • Drug: Opioids
    • Drug: Anesthetics, Local
  • Experimental: Erector spinae plane
    Ultrasound-guided erector spinae plane block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.
    Interventions:
    • Procedure: Erector spinae plane block
    • Drug: General anesthetic
    • Drug: Opioids
    • Drug: Anesthetics, Local
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 19, 2018)
42
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 1, 2019
Estimated Primary Completion Date August 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Derek Dillane, FCARCSI 7804071303 dillane@ualberta.ca
Contact: Michelle Verrier 7804078600 mrheault@ualberta.ca
Listed Location Countries  ICMJE Canada
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03471442
Other Study ID Numbers  ICMJE Pro00078230
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Derek Dillane, University of Alberta
Study Sponsor  ICMJE University of Alberta
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account University of Alberta
Verification Date March 2018

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP