Erector Spinae Plane Block Versus Paravertebral Block

NCT03471442 | Completed

• 1 other identifier: Pro00078230
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer; Pain, Postoperative; Anesthesia, Local

Outcome Measures

Primary Outcomes (1)

• Dermatomal spread of sensory blockade

  Assessment of extent of sensory block by pinprick

  30 minutes

Secondary Outcomes (4)

• Numerical Rating Scale (NRS) for pain

  Up to 24 hours

• Opioid analgesia use intra-operatively

  1 to 3 hours

• Total opioid use in the first 24 hours

  Up to 24 hours

• Block procedural time

  Up to 30 Minutes

Study Arms (2)

Paravertebral

ACTIVE COMPARATOR

Ultrasound-guided paravertebral block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Procedure: Paravertebral block; Drug: General anesthetic; Drug: Opioids; Drug: Anesthetics, Local

Erector spinae plane

EXPERIMENTAL

Ultrasound-guided erector spinae plane block performed pre-operatively with 20ml of a ropivacaine / bupivacaine mixture.

Procedure: Erector spinae plane block; Drug: General anesthetic; Drug: Opioids; Drug: Anesthetics, Local

Interventions

Paravertebral block PROCEDURE

Ultrasound-guided paravertebral block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Paravertebral

Erector spinae plane block PROCEDURE

Ultrasound-guided erector spinae plane block performed pre-operatively in the anesthesia block room with 20ml of a ropivacaine / bupivacaine mixture.

Erector spinae plane

General anesthetic DRUG

General anesthesia administered as per preference of intra-operative attending anesthesiologist

Erector spinae plane; Paravertebral

Opioids DRUG

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.

Erector spinae plane; Paravertebral

Anesthetics, Local DRUG

Weight-based dosing of this local anesthetic mixture.

Also known as: Ropivacaine / bupivacaine mixture to a final concentration of 0.125% bupivacaine and 0.5% ropivacaine

Erector spinae plane; Paravertebral

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adult patients over 18 years
• Consented to a regional anesthesia technique for post-operative analgesia
• Partial or complete mastectomy

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Alberta: lead

Study Sites (1)

University of Alberta

Edmonton, Alberta, T6G 2B7, Canada

Location

Related Publications (8)

• 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.

  PMID: 19624418 BACKGROUND

• 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.

  PMID: 24071616 BACKGROUND

• 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. doi: 10.1097/00000542-200610000-00008.

  PMID: 17006061 BACKGROUND

• 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.

  PMID: 28188621 BACKGROUND

• 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.

  PMID: 28272292 BACKGROUND

• 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.

  PMID: 28919152 BACKGROUND

• Munoz 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. No abstract available.

  PMID: 28447318 BACKGROUND

• 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.

  PMID: 27501016 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms; Pain, Postoperative

Interventions

Anesthetics, General; Analgesics, Opioid; Anesthetics, Local; Ropivacaine; Bupivacaine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anesthetics; Central Nervous System Depressants; Physiological Effects of Drugs; Pharmacologic Actions; Chemical Actions and Uses; Central Nervous System Agents; Therapeutic Uses; Narcotics; Analgesics; Sensory System Agents; Peripheral Nervous System Agents; Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 20, 2018
• Study Start: May 29, 2018
• Primary Completion: April 27, 2021
• Study Completion: April 27, 2021
• Last Updated: July 28, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)