CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 62 enrolled
Drug / intervention
Erector Spinae Plane (ESP) Block +1 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03691922
NCT03691922N/ACompleted

Randomized Control Trial of Ultrasound-Guided Erector Spinae Block Versus Shoulder Periarticular Anesthetic Infiltration for Pain Control After Arthroscopic Shoulder Surgery

McMaster University·interventional·Posted Oct 2, 2018·Updated Feb 24, 2021

In Brief

A clinical study evaluating Erector Spinae Plane (ESP) Block and Periarticular Infiltration (PAI) for Arthroscopic Shoulder Surgery. Completed, enrolled 62 participants across 1 site.

Detailed Summary

Arthroscopic shoulder surgery is a common and minimally invasive procedure utilized for different shoulder pathologies, but it is often associated with moderate to severe postoperative pain that may interfere with patients' well-being and course of recovery. By using an effective analgesic technique with few side effects, a patient may experience less pain after surgery, have a shortened hospital stay, and endure less nausea, vomiting, or excessive drowsiness that are associated with the use of opioids to manage postoperative pain. Periarticular infiltration (PAI) with local anesthetic (LA) has been used for shoulder surgery pain management, but the more effective interscalene nerve block (ISNB) is the current gold standard analgesic modality despite risk of significant side effects including diaphragm paralysis and rebound pain. In this study, the investigators want to look at the effectiveness and safety profile of a novel technique for pain management after shoulder surgery that has the potential to provide successful pain relief with minimal risk of side effects. Half of the patients will be randomly selected to receive the novel nerve block called the Erector Spinae Plane (ESP) block while the other half will receive a more standard PAI of local anesthetic to numb the shoulder. Patients' pain intensity and opioid consumption in the post-anesthesia care unit (PACU) as well as during the first 24 hours after surgery will be evaluated. Any complications from the interventions will also be noted. The investigators predict that the ESP block will provide superior analgesia compared to PAI for these shoulder arthroscopy patients.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedOct 2, 2018
Enrollment StartJul 6, 2019
Primary CompletionFeb 1, 2020
Study CompletionFeb 1, 2021
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 7.8 years ago

Interventions

Erector Spinae Plane (ESP) Blockprocedure

1. Preoperative US guided ESP blockade using 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine, injected in 5-mL aliquots through the needle (maximum of 3 mg/kg) 2. PAI of 30 mL of saline at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle

Periarticular Infiltration (PAI)procedure

1. Preoperative US guided ESP blockade using 30 mL of saline, injected in 5-mL aliquots through the needle 2. PAI of 30 mL of 0.25% bupivacaine with 5 mcg/mL of epinephrine at the end of the surgical procedure on the operated side rotator cuff, injected in 5-mL aliquots through the needle