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

NCT ID: NCT03419117

Last Updated: 2021-05-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 80 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-07-03
• Study Completion Date: 2020-12-31

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.

Detailed Description

Purpose To investigate the postoperative analgesic effectiveness of the ultrasound-guided ESP block compared to a placebo injection for patients undergoing thoracoscopic wedge resection of the lung.

Hypothesis Thoracoscopic surgery patients who receive an ESP block in addition to current standard of care, consisting of parenteral and enteral opioids and surgical wound infiltration, will have a clinically significant improvement in their QoR-40 at POD 1 and lower pain levels, as measured by VAS in the PACU on arrival and one hour after, and on POD 1, and OME opioid consumption in the PACU and at 24 hours post-operatively, in comparison to those patients who receive the current standard of care along with a placebo injection.

Justification The ESP block is a novel regional anesthetic technique that has shown efficacy in the management of thoracic pain as published in numerous case reports and observational case series. To date, no randomized control trials exist of its efficacy in comparison to conventional parental opioid analgesic management. Thoracoscopic wedge resections of the lung are procedures not usually treated with regional analgesia techniques, but given the moderate pain experienced by many patients, this surgical population will serve as a proof-of-concept for the potential of improved post-operative analgesic and recovery profiles. Proof of analgesic efficacy in this setting may allow a future head-to-head comparison with more invasive analgesic techniques currently used for thoracic surgery such as epidural and paravertebral catheterizations.

In undertaking this aim, we will measure a number of different metrics. The 40-item Quality of Recovery Score (QoR-40) will be our primary objective as it provides a patient-centered global measure of overall health in the postoperative period. It has been tested for validity and reliability, and has undergone quantification for the minimal clinically important difference. Other traditional metrics of analgesic performance including the VAS and 24-hour post-op OME opioid consumption will also be monitored as secondary objectives.

Objectives

Primary Objective:

• Quality-of-Recovery 40 scale at POD 1.

Secondary Objectives:

• Cumulative OME opioid consumption intra-operatively and through PACU, and at 24 hours post operatively.
• Visual analog pain scale assessments post-operatively in PACU on arrival, after 1 hour, and at POD 1.

Research Design The study will be a prospective, single center, randomized, placebo-controlled pilot study requiring 2 patient visits for assessment in the PACU and on POD 1. One interim analysis for safety monitoring will be undertaken.

Sample Size Calculation and Statistical Methods No prior studies have been conducted to calculate an exact sample size calculation. Based on similar work, we will power this study on an expected difference of at least 10 points on the QoR-40 and a SD of 15 when comparing the block to placebo. This is a clinically meaningful difference. Assuming an alpha level of 0.05 and a power of 0.80, our sample size is 74. With a 10% dropout rate we will require recruitment of 82 patients. All outcomes will be analysed with the independent student t-test.

Conditions

Regional Anesthesia; Pain, Postoperative

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Treatment

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

Group Type: EXPERIMENTAL

ESP block

Intervention Type: PROCEDURE

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

Placebo

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.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: PROCEDURE

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

Interventions

ESP block

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

Intervention Type: PROCEDURE

Placebo

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

Intervention Type: PROCEDURE

Eligibility Criteria

Inclusion Criteria

• 18-75 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

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of British Columbia

OTHER

Sponsor Role: lead

Responsible Party

Jason Wilson

Clinical Instructor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jason M Wilson, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

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

Vancouver, British Columbia, Canada

Countries

Canada

References

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.

Reference Type: DERIVED

PMID: 36150741 (View on PubMed)

Other Identifiers

H18-00029

Identifier Type: -

Identifier Source: org_study_id