Mode
Text Size
Log in / Sign up
Phase 4 N=33 Randomized Treatment

Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

Thoracic Surgical Procedures

Enrolled (actual)
33
Serious AEs
0.0%
Results posted
Jul 2023
Primary outcome: Primary: Total Opioid Consumption — 187.36; 164.70 mg morphine equivalent (MME)

Study Design & Population

Study type
Interventional
Phase
Phase 4
Interventions
Paravertebral nerve block (Drug); Erector Spinae nerve block (Drug)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
Charles Luke
Primary completion
Jun 2020

Outcome Measures

OutcomeResultp-value
PRIMARY
Total Opioid Consumption
187.36; 164.70
PRIMARY
Patient Reported Pain Scores
5.98; 5.16
SECONDARY
Amount Achieved on Incentive Spirometer
1221.15; 1187.50
SECONDARY
Length of Hospital Stay
101.96; 96.30
SECONDARY
Time Catheter Remains Inserted in Body
21.99; 21.94
SECONDARY
Averaged Total of Narcotic Usage
187.36; 164.7
SECONDARY
Report of Adverse Events From Catheter Placement
0; 0

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.

Eligibility Criteria

Inclusion criteria

  • 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

Exclusion criteria

  • 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)
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03758261). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

Back to search