Erector Spinae Plane Block Versus Paravertebral Block

July 25, 2022 updated by: University of Alberta

Erector Spinae Plane Block Versus Paravertebral Block in Patients Undergoing Elective Breast Surgery. A Randomized Controlled Trial Comparing Dermatomal Spread.

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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. 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

Interventional

Enrollment (Actual)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • University of Alberta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / 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 Names:
  • 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.
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 Names:
  • Ropivacaine / bupivacaine mixture to a final concentration of 0.125% bupivacaine and 0.5% ropivacaine
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Dermatomal spread of sensory blockade
Time Frame: 30 minutes
Assessment of extent of sensory block by pinprick
30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Up to 24 hours
Opioid analgesia use intra-operatively
Time Frame: 1 to 3 hours
Amount of opioid administered by the intra-operative anesthesiologist
1 to 3 hours
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
Up to 24 hours
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
Up to 30 Minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Alberta

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 29, 2018

Primary Completion (Actual)

April 27, 2021

Study Completion (Actual)

April 27, 2021

Study Registration Dates

First Submitted

March 1, 2018

First Submitted That Met QC Criteria

March 19, 2018

First Posted (Actual)

March 20, 2018

Study Record Updates

Last Update Posted (Actual)

July 28, 2022

Last Update Submitted That Met QC Criteria

July 25, 2022

Last Verified

July 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00078230

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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