NCT03758261

Erector Spinae Plane vs. Paravertebral Nerve Block for Thoracic Surgery

Completed Phase 4 Results posted Last updated 3 July 2023

What this trial tests

Phase 4 trial testing Paravertebral nerve block in Thoracic Surgical Procedures in 35 participants. Completed in 25 June 2020.

Timeline

11 March 2019

Primary endpoint
12 June 2020

25 June 2020

Quick facts

Lead sponsor	Charles Luke
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	11 March 2019
Primary completion	12 June 2020
Estimated completion	25 June 2020
Sites	1 location across United States

Drugs / interventions tested

• Paravertebral nerve block — full drug profile →
• Erector Spinae nerve block — full drug profile →

Conditions studied

• Thoracic Surgical Procedures — all drugs for Thoracic Surgical Procedures →

Sponsor

Charles Luke — full company profile →

Who can join

18 and older, any sex, with Thoracic Surgical Procedures. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Total Opioid Consumption Primary · 1 day post catheter removal

Morphine equivalents (total OME)

Group	Value	95% CI
Erector Spinae Nerve Block	187.36	± 184.35
Paravertebral Nerve Block	164.70	± 142.64

Patient Reported Pain Scores Primary · 1 day post catheter removal

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.

Group	Value	95% CI
Erector Spinae Nerve Block	5.98	± 2.21
Paravertebral Nerve Block	5.16	± 2.66

Amount Achieved on Incentive Spirometer Secondary · 1 day post catheter removal

Amount achieved on incentive spirometer device (mL). Higher level indicates better respiratory effort

Group	Value	95% CI
Erector Spinae Nerve Block	1221.15	± 480.77
Paravertebral Nerve Block	1187.50	± 541.27

Length of Hospital Stay Secondary · Up to 2 weeks on average

Length of hospital stay post-surgery

Group	Value	95% CI
Erector Spinae Nerve Block	101.96	± 49.99
Paravertebral Nerve Block	96.30	± 41.78

Time Catheter Remains Inserted in Body Secondary · 6 days

How long catheter remains providing pain relief

Group	Value	95% CI
Erector Spinae Nerve Block	21.99	± 12.96
Paravertebral Nerve Block	21.94	± 11.91

Averaged Total of Narcotic Usage Secondary · 0-120 hours post-operative

Averaged total Narcotic consumption measured in Oral Morphine Equivalence (OME)

Group	Value	95% CI
Erector Spinae Nerve Block	187.36	± 190.82
Paravertebral Nerve Block	164.7	± 147.64

Report of Adverse Events From Catheter Placement Secondary · 1 day post catheter removal

Participant count for patients who experienced adverse events with nerve block catheter placement which includes pneumothorax, infections, bleeding, local anesthetic toxicity.

Group	Value	95% CI
Erector Spinae Nerve Block	0
Paravertebral Nerve Block	0

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse event data was collected from time of admission until patient discharge, an average of 4-days.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Erector Spinae Nerve Block

Serious: 0/17 (0%)

Deaths: 0/17

Paravertebral Nerve Block

Serious: 0/16 (0%)

Deaths: 0/16

Other adverse events (3 terms — click to expand)

Reaction	System	Erector Spinae Nerve Block	Paravertebral Nerve Block
Atrial Fibrillation	Cardiac disorders	—	—
Respiratory Depression	Respiratory, thoracic and mediastinal disorders	—	—
Redo Nerve Block	Surgical and medical procedures	—	—

Data from ClinicalTrials.gov NCT03758261 adverse events section.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.