Erector Spinae Block for Thoracoscopic Surgery

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Postoperative Pain, Thoracic Neoplasms

Intervention / Treatment
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* Procedure: Erector Spinae Plane Block (for postoperative pain relief)


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized controlled double blind trial
Masking: Quadruple


Arms and Interventions

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

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Thoracoscopy, Pain, Regional anaesthesia