Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

NCT03758261 | Completed Phase 4 Results FDA Drug

• 1 other identifier: PRO18070064
• Study Type: interventional
• Target: 35
• Locations: 1 country
• Sites: 1

Brief Summary

Continuous paravertebral analgesia and erector spinae plane blockade (ESP) are accepted techniques at University of Pittsburgh Medical Center (UPMC) for the management of thoracic pain following surgery and trauma. Recently, an increasing number of erector spinae plane nerve blocks are being performed as it has been demonstrated in our institution, and via case reports that the blocks provide clinical effectiveness, but may have a better side-effect profile than the paravertebral nerve block. However, the relative efficacy of ESP compared to paravertebral nerve block remains to be established for video assisted thoracoscopic surgery (VATS). This is a prospective randomized study intended to assess the efficacy, safety and side-effect profile of continuous erector spinae plane analgesia versus continuous paravertebral analgesia for VATS procedures. It will include 60 patients presenting to UPMC Passavant for a VATS procedure. Patients will be randomized 1:1 to receive either a nerve block via continuous paravertebral infusion or via erector spinae plane infusion. In addition, to treat breakthrough pain, the patients in both arms will receive multimodal adjunctive therapy per routine. Bupivacaine and ropivacaine are FDA approved for use in nerve block catheters. The primary outcome will be to compare analgesic efficacy between the two nerve blocks as defined by total opioid consumption and pain scores on the numeric pain rating scale. Secondary outcomes include incentive spirometer amounts (baseline vs daily score postoperatively), length of stay, duration of catheter and report of adverse events or complications. Other data points include number of chest tubes and location and level of catheter and nerve block placement as well as number of blocks per case.

Conditions

Thoracic Surgical Procedures

Keywords

VATS; Regional Anesthesia; Paravertebral nerve block; Erector Spinae nerve block; Video assisted thoracoscopic surgery

Outcome Measures

Primary Outcomes (2)

• Total Opioid Consumption

  Morphine equivalents (total OME)

  1 day post catheter removal

• Patient Reported Pain Scores

  Visual analog scale. Scale is from 0 to 10 numerical pain rating scale. 0 indicates no pain. 10 indicates maximum level of pain. Higher scores indicate worse pain level. Pain score will be a single number from 0 to 10.

  1 day post catheter removal

Secondary Outcomes (5)

• Amount Achieved on Incentive Spirometer

  1 day post catheter removal

• Length of Hospital Stay

  Up to 2 weeks on average

• Time Catheter Remains Inserted in Body

  6 days

• Averaged Total of Narcotic Usage

  0-120 hours post-operative

• Report of Adverse Events From Catheter Placement

  1 day post catheter removal

Study Arms (2)

Erector Spinae Nerve Block

OTHER

Erector Spinae nerve block

Drug: Erector Spinae nerve block

Paravertebral Nerve Block

OTHER

Paravertebral nerve block

Drug: Paravertebral nerve block

Interventions

Paravertebral nerve block DRUG

The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound Paravertebral Nerve Block will be performed.

Paravertebral Nerve Block

Erector Spinae nerve block DRUG

The patient will be placed in a sitting position and the level of needle insertion will be marked corresponding to the level of surgical incision. With sterile technique an ultrasound erector spinae nerve block will be performed.

Erector Spinae Nerve Block

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients undergoing VATS agreeable to have a nerve block as analgesic technique
• Age: 18 years old and older.
• ASA (American Society of Anesthesiologists Class) I-IV

You may not qualify if:

• Cognitive impairment that would not allow effective nerve block placement or gathering information related to the study (ex. pain score).
• Contraindications for nerve block placement such as coagulopathy, use of clopidogrel in the past 48hs, patients on dual antiplatelet therapy, infection at the site of puncture, patient refusal, allergy to local anesthetics.
• Chronic opiate consumption
• Patient expected to be on therapeutic anticoagulation post procedure.
• Pregnancy
• Comorbid conditions: Any comorbid condition that in the judgment of the anesthesiologist would preclude the patient from any aspect of the study (ex. sepsis, possibly abnormalities of the thoracic spine or paravertebral anatomy such as neoplastic mass occupying the space, empyema, increased intracranial pressure)

Sponsors & Collaborators

• Charles Luke: lead

Study Sites (1)

UPMC Passavant

Pittsburgh, Pennsylvania, 15237, United States

Location

Related Publications (6)

• D'Ercole F, Arora H, Kumar PA. Paravertebral Block for Thoracic Surgery. J Cardiothorac Vasc Anesth. 2018 Apr;32(2):915-927. doi: 10.1053/j.jvca.2017.10.003. Epub 2017 Oct 4.

  PMID: 29169795 BACKGROUND

• Yeung JH, Gates S, Naidu BV, Wilson MJ, Gao Smith F. Paravertebral block versus thoracic epidural for patients undergoing thoracotomy. Cochrane Database Syst Rev. 2016 Feb 21;2(2):CD009121. doi: 10.1002/14651858.CD009121.pub2.

  PMID: 26897642 BACKGROUND

• Tsui BCH, Fonseca A, Munshey F, McFadyen G, Caruso TJ. The erector spinae plane (ESP) block: A pooled review of 242 cases. J Clin Anesth. 2019 Mar;53:29-34. doi: 10.1016/j.jclinane.2018.09.036. Epub 2018 Oct 3.

  PMID: 30292068 BACKGROUND

• Hamilton DL, Manickam B. Erector spinae plane block for pain relief in rib fractures. Br J Anaesth. 2017 Mar 1;118(3):474-475. doi: 10.1093/bja/aex013. No abstract available.

  PMID: 28203765 BACKGROUND

• Ueshima H, Otake H. RETRACTED: Clinical experiences of ultrasound-guided erector spinae plane block for thoracic vertebra surgery. J Clin Anesth. 2017 May;38:137. doi: 10.1016/j.jclinane.2016.12.028. Epub 2017 Feb 17. No abstract available.

  PMID: 28372654 BACKGROUND

• Luis-Navarro JC, Seda-Guzman M, Luis-Moreno C, Lopez-Romero JL. The erector spinae plane block in 4 cases of video-assisted thoracic surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Apr;65(4):204-208. doi: 10.1016/j.redar.2017.12.004. Epub 2018 Jan 11. English, Spanish.

  PMID: 29336785 BACKGROUND

Results Point of Contact

• Title: Dr. Charles Luke
• Organization: University of Pittsburgh Medical Center

lukecb@upmc.edu

4127485589

Study Officials

• Charles Luke, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Assistant Professor

Model Details: 2 groups of patients will be studied simultaneously. One group will have the intervention of the nerve block in the erector spinae approach and the other group will have the nerve block in the traditional paravertebral approach.

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: November 29, 2018
• Study Start: March 11, 2019
• Primary Completion: June 12, 2020
• Study Completion: June 25, 2020
• Last Updated: July 3, 2023
• Results First Posted: July 3, 2023

Record last verified: 2023-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)