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

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Sponsor:

Information provided by (Responsible Party):

Derek Dillane, University of Alberta

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Breast Cancer Pain, Postoperative Anesthesia, Local	Procedure: Paravertebral block Procedure: Erector spinae plane block Drug: General anesthetic Drug: Opioids Drug: Anesthetics, Local	Not Applicable

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Study Design

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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, 2019
Estimated Study Completion Date :	December 1, 2019

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Breast cancer

U.S. FDA Resources

Arms and Interventions

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 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.	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

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 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.

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

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

Outcome Measures

Primary Outcome Measures :

Dermatomal spread of sensory blockade [ Time Frame: 30 minutes ]
Assessment of extent of sensory block by pinprick

Secondary Outcome Measures :

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

Eligibility Criteria

Information from the National Library of Medicine

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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:

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

Contacts and Locations

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): NCT03471442

Contacts

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Contact: Derek Dillane, FCARCSI	7804071303	dillane@ualberta.ca
Contact: Michelle Verrier	7804078600	mrheault@ualberta.ca

Locations

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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

Sponsors and Collaborators

University of Alberta

More Information

Publications:

Boughey JC, Goravanchi F, Parris RN, Kee SS, Frenzel JC, Hunt KK, Ames FC, Kuerer HM, Lucci A. Improved postoperative pain control using thoracic paravertebral block for breast operations. Breast J. 2009 Sep-Oct;15(5):483-8. doi: 10.1111/j.1524-4741.2009.00763.x. Epub 2009 Jul 13.

Abdallah FW, Morgan PJ, Cil T, McNaught A, Escallon JM, Semple JL, Wu W, Chan VW. Ultrasound-guided multilevel paravertebral blocks and total intravenous anesthesia improve the quality of recovery after ambulatory breast tumor resection. Anesthesiology. 2014 Mar;120(3):703-13. doi: 10.1097/ALN.0000436117.52143.bc.

Exadaktylos AK, Buggy DJ, Moriarty DC, Mascha E, Sessler DI. Can anesthetic technique for primary breast cancer surgery affect recurrence or metastasis? Anesthesiology. 2006 Oct;105(4):660-4.

Chin KJ, Adhikary S, Sarwani N, Forero M. The analgesic efficacy of pre-operative bilateral erector spinae plane (ESP) blocks in patients having ventral hernia repair. Anaesthesia. 2017 Apr;72(4):452-460. doi: 10.1111/anae.13814. Epub 2017 Feb 11.

Chin KJ, Malhas L, Perlas A. The Erector Spinae Plane Block Provides Visceral Abdominal Analgesia in Bariatric Surgery: A Report of 3 Cases. Reg Anesth Pain Med. 2017 May/Jun;42(3):372-376. doi: 10.1097/AAP.0000000000000581.

Forero M, Rajarathinam M, Adhikary S, Chin KJ. Erector spinae plane (ESP) block in the management of post thoracotomy pain syndrome: A case series. Scand J Pain. 2017 Oct;17:325-329. doi: 10.1016/j.sjpain.2017.08.013. Epub 2017 Sep 12.

Muñoz F, Cubillos J, Bonilla AJ, Chin KJ. Erector spinae plane block for postoperative analgesia in pediatric oncological thoracic surgery. Can J Anaesth. 2017 Aug;64(8):880-882. doi: 10.1007/s12630-017-0894-0. Epub 2017 Apr 26.

Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.

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Responsible Party:	Derek Dillane, Associate professor, University of Alberta
ClinicalTrials.gov Identifier:	NCT03471442 History of Changes
Other Study ID Numbers:	Pro00078230
First Posted:	March 20, 2018 Key Record Dates
Last Update Posted:	March 20, 2018
Last Verified:	March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD:	No

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Studies a U.S. FDA-regulated Drug Product:		No
Studies a U.S. FDA-regulated Device Product:		No

Additional relevant MeSH terms:

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Pain, Postoperative Postoperative Complications Pathologic Processes Pain Neurologic Manifestations Signs and Symptoms Analgesics, Opioid Bupivacaine Ropivacaine	Anesthetics, Local Anesthetics Anesthetics, General Central Nervous System Depressants Physiological Effects of Drugs Sensory System Agents Peripheral Nervous System Agents Narcotics Analgesics

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