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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04751552
Other study ID # L20.047
Secondary ID
Status Completed
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


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
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