Back to resultsErector Spinae Block for Thoracoscopic Surgery
Primary Purpose
Postoperative Pain, Thoracic Neoplasms
Status
Completed
Phase
Not Applicable
Locations
Netherlands
Study Type
Interventional
Intervention
Erector Spinae Plane Block (for postoperative pain relief)
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring Thoracoscopy, Pain, Regional anaesthesia
Eligibility Criteria
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
Sites / Locations
- St Antonius Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Levobupivacaine group
Placebo group
Arm Description
Patients receive an ESPB with the local anaesthetic levobupivacaine
Patients receive an ESPB with 0,9% saline
Outcomes
Primary Outcome Measures
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
Pain intensity (NRS) 4 hours after surgery.
Pain level 4 hours after surgery
Pain intensity (NRS) 8 hours after surgery.
Pain level 8 hours after surgery
Pain intensity (NRS) 12 hours after surgery.
Pain level twelve hours after surgery
Secondary Outcome Measures
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
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
Opioid consumption
Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device
length of stay in recovery ward (minutes)
length of stay in recovery ward (minutes) 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)
Presence of side effects
Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))
Full Information
NCT ID
NCT04751552
First Posted
October 14, 2020
Last Updated
September 9, 2023
Sponsor
St. Antonius Hospital
1. Study Identification
Unique Protocol Identification Number
NCT04751552
Brief Title
Erector Spinae Block for Thoracoscopic Surgery
Official Title
Effect of Erector Spinae Plane Block on Postoperative Pain Intensity in Patients Undergoing Thoracoscopic Surgery: a Randomized Clinical Trial.
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Completed
Study Start Date
October 21, 2020 (Actual)
Primary Completion Date
September 1, 2023 (Actual)
Study Completion Date
September 2, 2023 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Antonius Hospital
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Thoracic Neoplasms
Keywords
Thoracoscopy, Pain, Regional anaesthesia
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Randomized controlled double blind trial
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double blind
Allocation
Randomized
Enrollment
60 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Levobupivacaine group
Arm Type
Active Comparator
Arm Description
Patients receive an ESPB with the local anaesthetic levobupivacaine
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Patients receive an ESPB with 0,9% saline
Intervention Type
Procedure
Intervention Name(s)
Erector Spinae Plane Block (for postoperative pain relief)
Intervention Description
A ultrasound guided single bolus injection of 20 ml of levobupivacaine or placebo between the erector spinae muscle and process transversus of vertebra T5.
Primary Outcome Measure Information:
Title
Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery.
Description
Pain level 2 hours after surgery
Time Frame
2 hours postoperatively
Title
Pain intensity (NRS) 4 hours after surgery.
Description
Pain level 4 hours after surgery
Time Frame
4 hours postoperatively
Title
Pain intensity (NRS) 8 hours after surgery.
Description
Pain level 8 hours after surgery
Time Frame
8 hours postoperatively
Title
Pain intensity (NRS) 12 hours after surgery.
Description
Pain level twelve hours after surgery
Time Frame
12 hours postoperatively
Secondary Outcome Measure Information:
Title
Pain intensity (NRS) at 8.00 o'clock on the first postoperative day
Description
Pain level at 8.00 o'clock on the first postoperative day
Time Frame
At 8 o'clock AM on the first postoperative day
Title
Pain intensity (NRS) at 20.00 o'clock on the first postoperative day
Description
Pain level at 20.00 o'clock on the first postoperative day
Time Frame
At 8 o'clock PM on the first postoperative day
Title
Opioid consumption
Description
Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device
Time Frame
First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day.
Title
length of stay in recovery ward (minutes)
Description
length of stay in recovery ward (minutes) after surgery
Time Frame
First 48 hours after surgery
Title
Patient satisfaction of pain therapy
Description
Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied)
Time Frame
Measurement in the morning of the second postoperative day
Title
Presence of side effects
Description
Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))
Time Frame
First 48 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Facility Information:
Facility Name
St Antonius Hospital
City
Nieuwegein
State/Province
Utrecht
ZIP/Postal Code
3435 CM
Country
Netherlands
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Relevant participant data underlying the final results and conclusions of the study.
IPD Sharing Time Frame
Following the report of the study
Learn more about this trial
Erector Spinae Block for Thoracoscopic Surgery
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