ESP Block vs. Traditional Pain Management for ERAS

Erector Spinae Plane Block Versus Traditional Pain Management for Enhanced Recovery After Surgery

Patients undergoing thoracotomy, thoracoscopy or other surgical procedures involving the integrity of the chest wall are always in a special point of interest of both surgical and anesthesiological specialities. Most of the patients will describe the pain after thoracic surgery as severe. It might lead to a number of serious complications: respiratory failure due to splinting; inability to clear secretions by effective coughing, with resulting pneumonia; and turning into a chronic pain: the post-thoracotomy pain syndrome.

Traditional pain management in these groups of patients - such as opiate treatment, thoracic epidural analgesia, and non-opioid drugs - may have serious side effects. Large doses of opiates suppress the cough reflex and lead to respiratory depression with subsequent re-intubation and re-ventilation. Thoracic epidural analgesia, though being considered paramount among other analgesic options, requires a significant clinical experience. Still, it might be insufficient for satisfactory pain control and even complicated with pneumothorax, total spinal anaesthesia and inadvertent intravascular injection. Non-steroidal anti-inflammatory drugs (NSAIDs) and Tramadol are weak analgesics inadequate for severe pain control and might be responsible for gastrointestinal bleeding.

We suggest performing erector spinae plane block for intraoperative and postoperative pain management due to the ease of use and better analgesic effect. What remains is hard proof for the clinical efficacy and safety of this block, followed by a demonstration of the uptake of it in the hands of non-regional anaesthetists.

Study Overview

• Status: Unknown
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Erector spinae plane block

• Study Type: Interventional
• Enrollment (Anticipated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Dmitry Natanel, MD; Phone Number: +972533360451; Email: nataneld@bgu.ac.il
• Study Contact Backup: Name: Michael Dubilet, MD; Email: michaeldu@clalit.org.il

Study Locations

• Israel
  • Beersheba, Israel
    • Recruiting
    • SorokaUMC
    • Contact: Dmitry Natanel, MD; Phone Number: 0533360451; Email: nataneld@bgu.ac.il

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• all consecutive adult patients who undergo thoracic, spinal or abdominal surgery in Soroka Medical Center, and agree to participate in the study, older than 18 years, who meet criteria of ASA physical status I-II-III-IV class.

Exclusion Criteria:

• Unconscious or mentally incompetent patients or those who refuse to participate in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

6

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Thoracic surgery + ESPblock; Thoracic surgery + ESPblock + standard pain management	Procedure: Erector spinae plane block; Erector spinae plane block
Experimental: Abdominal surgery + ESPblock; Abdominal surgery + ESPblock + standard pain management	Procedure: Erector spinae plane block; Erector spinae plane block
Experimental: Spinal surgery + ESPblock; Spinal surgery + ESPblock + standard pain management	Procedure: Erector spinae plane block; Erector spinae plane block
No Intervention: Thoracic surgery; Thoracic surgery + standard pain management
No Intervention: Abdominal surgery; Abdominal surgery + standard pain management
No Intervention: Spinal surgery; Spinal surgery + standard pain management

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Visual Analog Pain Score	Reported immediate postoperative VAS score, up to 3rd day	3 days
Total pain med consumption in the PACU	Total Morphine, NSAIDs and Tramadol amount (mg) in the PACU	3 hours
Length of stay in the PACU	Length of stay in postoperative care room	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Length of hospital stay	Length of hospital stay	30 days
Chronic pain development	Rate of chronic pain at 3 and 6 months after surgery	6 months

Collaborators and Investigators

• Sponsor: Soroka University Medical Center
• Investigators: Principal Investigator: Michael Dubilet, MD, Soroka University Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): March 5, 2020
• Primary Completion (Anticipated): March 5, 2021
• Study Completion (Anticipated): September 5, 2021

Study Registration Dates

• First Submitted: March 5, 2020
• First Submitted That Met QC Criteria: March 5, 2020
• First Posted (Actual): March 6, 2020

Study Record Updates

• Last Update Posted (Actual): March 6, 2020
• Last Update Submitted That Met QC Criteria: March 5, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Keywords: Postoperative pain; Erector spinae plane block
• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative
• Other Study ID Numbers: 0355-19-SOR

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No