Erector Spinae Block for Thoracoscopic Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04751552
• Other study ID #: L20.047
• Status: Completed
• Phase: N/A
• Start date: October 21, 2020
• Est. completion date: September 2, 2023

Study information

• Verified date: September 2023
• Source: St. Antonius Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 60
• Est. completion date: September 2, 2023
• Est. primary completion date: September 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain
• Thoracic Neoplasms

Intervention

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.

Locations

Country	Name	City	State
Netherlands	St Antonius Hospital	Nieuwegein	Utrecht

Sponsors (1)

Lead Sponsor	Collaborator
St. Antonius Hospital

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Pain intensity (NRS) 4 hours after surgery.	Pain level 4 hours after surgery	4 hours postoperatively
Primary	Pain intensity (NRS) 8 hours after surgery.	Pain level 8 hours after surgery	8 hours postoperatively
Primary	Pain intensity (NRS) 12 hours after surgery.	Pain level twelve hours after surgery	12 hours postoperatively
Secondary	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
Secondary	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
Secondary	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.
Secondary	length of stay in recovery ward (minutes)	length of stay in recovery ward (minutes) after surgery	First 48 hours after surgery
Secondary	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
Secondary	Presence of side effects	Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))	First 48 hours