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 : October 14, 2019
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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 |
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Breast Cancer Pain, Postoperative Anesthesia, Local | Procedure: Paravertebral block Procedure: Erector spinae plane block Drug: General anesthetic Drug: Opioids Drug: Anesthetics, Local | Not Applicable |

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, 2020 |
Estimated Study Completion Date : | December 1, 2020 |

Arm | Intervention/treatment |
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Active Comparator: Paravertebral
Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.
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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.
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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 |
- Dermatomal spread of sensory blockade [ Time Frame: 30 minutes ]Assessment of extent of sensory block by pinprick
- 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

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

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
Contact: Derek Dillane, FCARCSI | 7804071303 | dillane@ualberta.ca | |
Contact: Michelle Verrier | 7804078600 | mrheault@ualberta.ca |
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 |
Responsible Party: | Derek Dillane, Associate professor, University of Alberta |
ClinicalTrials.gov Identifier: | NCT03471442 |
Other Study ID Numbers: |
Pro00078230 |
First Posted: | March 20, 2018 Key Record Dates |
Last Update Posted: | October 14, 2019 |
Last Verified: | October 2019 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Bupivacaine Ropivacaine |
Anesthetics, Local Anesthetics Anesthetics, General Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents |