Erector Spinae Versus Paravertebral Nerve Blocks for Breast Surgery

NCT03549234 | Completed Phase 4 Results FDA Drug

• 1 other identifier: Erector Spinae vs PVB
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

Following painful surgical procedures of the breast, postoperative analgesia is often provided with a paravertebral nerve block (PVB). For intense, but shorter-duration acute pain, a single-injection of local anesthetic is used with a duration of approximately 12 hours. The PVB has several limitations: it can decrease blood pressure, and very rare-but serious-complications have occurred, including neuraxial injection, neuraxial hematoma, and pleural puncture. An alternative block has been described: the erector spinae plane block. The theoretical benefits include ease of administration since it is a plane superficial to the PVB and therefore easier to identify and target with ultrasound (therefore increasing success rate); and an increased safety margin: there are few anatomic structures in the immediate area which could be injured with the needle; and, the target plane is much further from the intrathecal/epidural space relative to the PVB. Lastly, the plane may be easier to catheterize for continuous peripheral nerve blocks relative to the relatively-small volume PVB. There are therefore multiple theoretical reasons to prefer the erector spinae plane block. Unfortunately, it remains unknown if the analgesia provided by this new technique is comparable to that provided with the PVB. The investigators therefore propose to compare these two techniques with a randomized, subject-masked, active-controlled, parallel-arm, human subjects clinical trial.

Conditions

Breast Surgery

Keywords

Regional anesthesia; Paravertebral; Erector spinae; Nerve block

Outcome Measures

Primary Outcomes (2)

• Numeric Rating Scale Pain Scores

  Range scale minimum 0, maximum 10. Lower pain scores are considered a better outcome, higher pain scores are considered a worse outcome.

  1 day (PACU pain scores)

• OR and PACU Opioid Consumption

  This outcome measure reflects the total amount of opioid administered in the operating room and recovery room perioperatively. Specific time points are not applicable since operating room and recovery room times differ among subjects.

  up to 1 day, in the OR and PACU

Other Outcomes (4)

• Nausea and Vomiting

  postoperative day 1

• Sleep Disturbances

  postoperative day 1

• Time of Block Resolution

  postoperative day 1

Study Arms (2)

Erector Spinae (single injection)

EXPERIMENTAL

Drug: Erector Spinae (single injection)

Paravertebral (single injection)

ACTIVE COMPARATOR

Drug: Paravertebral (single injection)

Interventions

Erector Spinae (single injection) DRUG

Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.

Erector Spinae (single injection)

Paravertebral (single injection) DRUG

Ropivacaine 0.5% (with epinephrine 1:200,000-400,000) will be administered via the needle into the target plane.

Paravertebral (single injection)

Eligibility Criteria

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

You may qualify if:

• undergoing unilateral or bilateral breast surgery with at least moderate postoperative pain anticipated
• analgesic plan includes a single-injection peripheral nerve block(s)
• age 18 years or older.

You may not qualify if:

• morbid obesity as defined by a body mass index \> 40 (BMI=weight in kg / \[height in meters\]2)
• renal insufficiency (preoperative creatinine \> 1.5 mg/dL)
• chronic opioid use (daily use within the 2 weeks prior to surgery and duration of use \> 4 weeks)
• history of opioid abuse
• any comorbidity which results in moderate or severe functional limitation
• inability to communicate with the investigators or hospital staff
• pregnancy
• planned regional analgesic with perineural catheter placement
• incarceration

Sponsors & Collaborators

• University of California, San Diego: lead

Study Sites (1)

UCSD Medical Center (Hillcrest and Thornton)

San Diego, California, 92103, United States

Location

Related Publications (8)

• Naja Z, Lonnqvist PA. Somatic paravertebral nerve blockade. Incidence of failed block and complications. Anaesthesia. 2001 Dec;56(12):1184-8. doi: 10.1046/j.1365-2044.2001.02084-2.x.

  PMID: 11736777 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

• Forero M, Rajarathinam M, Adhikary S, Chin KJ. Continuous Erector Spinae Plane Block for Rescue Analgesia in Thoracotomy After Epidural Failure: A Case Report. A A Case Rep. 2017 May 15;8(10):254-256. doi: 10.1213/XAA.0000000000000478.

  PMID: 28252539 BACKGROUND

• Ilfeld BM, Madison SJ, Suresh PJ, Sandhu NS, Kormylo NJ, Malhotra N, Loland VJ, Wallace MS, Proudfoot JA, Morgan AC, Wen CH, Wallace AM. Treatment of postmastectomy pain with ambulatory continuous paravertebral nerve blocks: a randomized, triple-masked, placebo-controlled study. Reg Anesth Pain Med. 2014 Mar-Apr;39(2):89-96. doi: 10.1097/AAP.0000000000000035.

  PMID: 24448512 BACKGROUND

• Finneran JJ 4th, Gabriel RA, Khatibi B. Erector Spinae Plane Blocks Provide Analgesia for Breast and Axillary Surgery: A Series of 3 Cases. Reg Anesth Pain Med. 2018 Jan;43(1):101-102. doi: 10.1097/AAP.0000000000000695. No abstract available.

  PMID: 29261601 BACKGROUND

• Kairaluoma PM, Bachmann MS, Korpinen AK, Rosenberg PH, Pere PJ. Single-injection paravertebral block before general anesthesia enhances analgesia after breast cancer surgery with and without associated lymph node biopsy. Anesth Analg. 2004 Dec;99(6):1837-1843. doi: 10.1213/01.ANE.0000136775.15566.87.

  PMID: 15562083 BACKGROUND

• Mascha EJ, Turan A. Joint hypothesis testing and gatekeeping procedures for studies with multiple endpoints. Anesth Analg. 2012 Jun;114(6):1304-17. doi: 10.1213/ANE.0b013e3182504435. Epub 2012 May 3.

  PMID: 22556210 BACKGROUND

• Swisher MW, Wallace AM, Sztain JF, Said ET, Khatibi B, Abanobi M, Finneran Iv JJ, Gabriel RA, Abramson W, Blair SL, Hosseini A, Dobke MK, Donohue MC, Ilfeld BM. Erector spinae plane versus paravertebral nerve blocks for postoperative analgesia after breast surgery: a randomized clinical trial. Reg Anesth Pain Med. 2020 Apr;45(4):260-266. doi: 10.1136/rapm-2019-101013. Epub 2020 Jan 21.

  PMID: 31969443 DERIVED

MeSH Terms

Interventions

Injections

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Results Point of Contact

• Title: Matthew Swisher, MD
• Organization: University of California San Diego

matthew.swisher@gmail.com

415-314-4099

Study Officials

• Brian M Ilfeld, MD MS

  Professor in Residence

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Anesthesiology, In Residence

Study Record Dates

• First Submitted: April 24, 2018
• First Posted: June 7, 2018
• Study Start: July 12, 2018
• Primary Completion: May 8, 2019
• Study Completion: May 8, 2019
• Last Updated: July 24, 2020
• Results First Posted: July 24, 2020

Record last verified: 2020-07

Locations

US (1)