Analgesic Efficacy of Single-shot Erector Spinae Block for Thoracic Surgery

NCT03419117 | Completed

• 1 other identifier: H18-00029
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The erector spinae plane (ESP) block is a novel regional anesthetic technique for the treatment of thoracic, cervical, and abdominal pain. This pilot study aims to investigate the post-operative analgesic effectiveness of ultrasound guided single-shot ESP blocks for patients undergoing minimally invasive thoracoscopic wedge resections of the lung in comparison to those receiving conventional parental opioid analgesia alone. This will be achieved through the use of objective measures including quality the 40 point Quality of Recovery assessment (QoR-40) on postoperative day (POD) 1, visual-analogue pain scale (VAS) in the post-anesthetic care unit (PACU) and at POD 1, and oral morphine-equivalent (OME) opioid consumption in the PACU and at 24 hours post-operatively.

Conditions

Regional Anesthesia; Pain, Postoperative

Outcome Measures

Primary Outcomes (1)

• Quality-of-Recovery 40 (QoR-40) scale at POD 1.

  The QoR-40 is a widely used and extensively validated measure of quality of recovery

  Postoperative day 1. Will be completed on the ward 24hrs after surgery

Secondary Outcomes (2)

• Morphine usage

  30 minutes post-operatively in the PACU and 24hr after surgery.

• Visual analog pain scale (VAS) assessments post-operatively in PACU, and at POD 1.

  30 minutes post-operatively in the PACU and 24hrs after surgery

Study Arms (2)

Treatment

EXPERIMENTAL

Patients in the experimental arm will receive an ESP block prior to induction of general anesthetic for their thoracoscopic wedge resection

Procedure: ESP block

Placebo

PLACEBO COMPARATOR

Patients allocated to the placebo-control arm will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block.

Procedure: Placebo

Interventions

ESP block PROCEDURE

An ESP block will be performed prior to surgery for postoperative pain control

Treatment

Placebo PROCEDURE

A sham ESP block will be performed before surgery in the placebo group

Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• years of age
• Presenting for elective thoracoscopic wedge resection
• Proficient in the use of the English language
• Able to provide informed consent
• Expected stay \> 24 hrs in hospital

You may not qualify if:

• ASA greater than, or equal to 4
• Expected post-operative endotracheal intubation
• High likelihood of conversion to open thoracotomy
• A diagnosis of a chronic pain condition
• Depression or other psychiatric diagnosis
• Dementia
• Pregnancy
• Preoperative opioid use \>30mg of oral morphine equivalents per day
• Known alcohol or recreational drug abuse
• Contraindication to local anesthetic use including allergy or sensitivity to ropivacaine or other amide-type local anesthetics
• Contraindication to the ESP block or regional anesthetic technique including: allergy or sensitivity to ultrasound gel; previous spine instrumentation; previous rib surgery; injured, diseased, or infected skin overlying the area to be blocked
• Perioperative use, or planned use, of alternative regional anesthetic technique (not including surgical local anesthetic infiltration)
• Perioperative ketamine and lidocaine infusion use

Sponsors & Collaborators

• University of British Columbia: lead

Study Sites (1)

UBC/Medicine, Faculty of/Anesthesiology, Pharmacology & Therapeutics

Vancouver, British Columbia, V5Z 1L8, Canada

Location

Related Publications (1)

• Klaibert B, Lohser J, Tang R, Jew M, McGuire A, Wilson J. Efficacy of ultrasound-guided single-injection erector spinae plane block for thoracoscopic wedge resection: a prospective randomized control trial. Reg Anesth Pain Med. 2022 Dec;47(12):749-754. doi: 10.1136/rapm-2022-103602. Epub 2022 Sep 23.

  PMID: 36150741 DERIVED

MeSH Terms

Conditions

Pain, Postoperative

Condition Hierarchy (Ancestors)

Postoperative Complications; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Jason M Wilson, MD PhD

  University of British Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Recruited patients will be allocated to an experimental or placebo-control arm. Patients in the experimental arm will receive an ESP block prior to induction of general anesthetic for their thoracoscopic wedge resection, while patients allocated to the placebo-control arm will receive a placebo injection of normal saline in a fashion almost identical to that of the ESP block.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Instructor

Study Record Dates

• First Submitted: January 12, 2018
• First Posted: February 1, 2018
• Study Start: July 3, 2018
• Primary Completion: December 31, 2020
• Study Completion: December 31, 2020
• Last Updated: May 11, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)