Erector Spinae Block for Thoracoscopic Surgery

Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.

This randomized clinical trial compares the effects of the erector spinae plane block with levobupivacaine and 0,9% saline on postoperative pain intensity, and opioid consumptions following thoracoscopic pulmonary surgery.

Study Overview

• Status: Completed
• Conditions: Thoracic Neoplasms; Postoperative Pain
• Intervention / Treatment: Procedure: Erector Spinae Plane Block (for postoperative pain relief)

Detailed Description

Sixty patients planned for thoracoscopic pulmonary surgery are randomly assigned to an erector spinae plane block (ESPB) with levobupivacaine (intervention group) or 0,9% saline (control group). ESPB is performed under general anaesthesia before surgery.

Postoperative pain medication incudes acetominophen, NSAIDs en parenteral morphine (patient controlled analgesia).

Following surgery pain intensity (numeric rating scale) is registered at the recovery ward one hour after surgery. Furthermore, pain intensity is registered 2,4,8, 12 hours after the operation. On the first postoperative day, pain intensity is registered at 8.00 o'cock AM and 8.00 o'clock PM. Opioid consumption is registered as a second parameter of postoperative pain.

• Study Type: Interventional
• Enrollment (Actual): 60
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Utrecht
    • Nieuwegein, Utrecht, Netherlands, 3435 CM
      • St Antonius Hospital

Participation Criteria

Eligibility Criteria

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

Description

Inclusion Criteria:

• Patients scheduled for thoracoscopic pulmonary sleeve resection or lobectomy

• Age 18 years or older

  • American Society of Anesthesiologists (ASA) health status class I-III
  • Informed consent

Exclusion Criteria:

• Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
• Contraindication for NSAIDs
• Chronic opioid use
• Pregnancy

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Levobupivacaine group; Patients receive an ESPB with the local anaesthetic levobupivacaine	Procedure: Erector Spinae Plane Block (for postoperative pain relief); A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.
Placebo Comparator: Placebo group; Patients receive an ESPB with 0,9% saline	Procedure: Erector Spinae Plane Block (for postoperative pain relief); A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.	Pain level 2 hours after surgery	2 hours postoperatively
Pain intensity (NRS) 4 hours after surgery.	Pain level 4 hours after surgery	4 hours postoperatively
Pain intensity (NRS) 8 hours after surgery.	Pain level 8 hours after surgery	8 hours postoperatively
Pain intensity (NRS) 12 hours after surgery.	Pain level twelve hours after surgery	12 hours postoperatively

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pain intensity (NRS) at 8.00 o'clock on the first postoperative day	Pain level at 8.00 o'clock on the first postoperative day	At 8 o'clock AM on the first postoperative day
Pain intensity (NRS) at 20.00 o'clock on the first postoperative day	Pain level at 20.00 o'clock on the first postoperative day	At 8 o'clock PM on the first postoperative day
Opioid consumption	Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device	First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
length of stay in recovery ward (minutes)	length of stay in recovery ward (minutes) after surgery	First 48 hours after surgery
Patient satisfaction of pain therapy	Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied)	Measurement in the morning of the second postoperative day
Presence of side effects	Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))	First 48 hours

Collaborators and Investigators

• Sponsor: St. Antonius Hospital

Study record dates

Study Major Dates

• Study Start (Actual): October 21, 2020
• Primary Completion (Actual): September 1, 2023
• Study Completion (Actual): September 2, 2023

Study Registration Dates

• First Submitted: October 14, 2020
• First Submitted That Met QC Criteria: February 11, 2021
• First Posted (Actual): February 12, 2021

Study Record Updates

• Last Update Posted (Actual): September 13, 2023
• Last Update Submitted That Met QC Criteria: September 9, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Keywords: Pain; Thoracoscopy; Regional anaesthesia
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Neoplasms by Site; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Thoracic Neoplasms
• Other Study ID Numbers: L20.047

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Relevant participant data underlying the final results and conclusions of the study.
• IPD Sharing Time Frame: Following the report of the study
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No