Postoperative Pain, Thoracic Neoplasms
Conditions
Keywords
Thoracoscopy, Pain, Regional anaesthesia
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.
Interventions
PROCEDUREErector 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.
Sponsors
St. Antonius Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Double blind
Intervention model description
Randomized controlled double blind trial
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pain intensity (numeric rating scale (NRS) (0=no pain up to 10=most pain imaginable) 2 hours after surgery. | 2 hours postoperatively | Pain level 2 hours after surgery |
| Pain intensity (NRS) 4 hours after surgery. | 4 hours postoperatively | Pain level 4 hours after surgery |
| Pain intensity (NRS) 8 hours after surgery. | 8 hours postoperatively | Pain level 8 hours after surgery |
| Pain intensity (NRS) 12 hours after surgery. | 12 hours postoperatively | Pain level twelve hours after surgery |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patient satisfaction of pain therapy | Measurement in the morning of the second postoperative day | Patient satisfaction of pain therapy (numeric rating scale 0-10(0=severely dissatisfied up to 10= maximally satisfied) |
| Pain intensity (NRS) at 8.00 o'clock on the first postoperative day | At 8 o'clock AM on the first postoperative day | Pain level at 8.00 o'clock on the first postoperative day |
| Presence of side effects | First 48 hours | Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no)) |
| Pain intensity (NRS) at 20.00 o'clock on the first postoperative day | At 8 o'clock PM on the first postoperative day | Pain level at 20.00 o'clock on the first postoperative day |
| Opioid consumption | First 48 hours after surgery, recorded following disconnection of the PCA device at 8 o'clock AM on the second postoperative day. | Parenteral morphine use (mg) as recorded by the Patient-Controlled Analgesia (PCA) device |
| length of stay in recovery ward (minutes) | First 48 hours after surgery | length of stay in recovery ward (minutes) after surgery |
Countries
Netherlands
Outcome results
None listed