Erector Spinae Block for Thoracoscopic Surgery
- Conditions
- Thoracic NeoplasmsPostoperative Pain
- Interventions
- Procedure: Erector Spinae Plane Block (for postoperative pain relief)
- Registration Number
- NCT04751552
- Lead Sponsor
- St. Antonius Hospital
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
-
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
- Contraindication for regional analgesia (e.g. coagulopathy, infection at injection site)
- Contraindication for NSAIDs
- Chronic opioid use
- Pregnancy
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Levobupivacaine group Erector Spinae Plane Block (for postoperative pain relief) Patients receive an ESPB with the local anaesthetic levobupivacaine Placebo group Erector Spinae Plane Block (for postoperative pain relief) Patients receive an ESPB with 0,9% saline
- Primary Outcome Measures
Name Time Method Pain intensity (NRS) 4 hours after surgery. 4 hours postoperatively Pain level 4 hours after surgery
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) 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 Outcome Measures
Name Time Method 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
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
length of stay in recovery ward (minutes) First 48 hours after surgery length of stay in recovery ward (minutes) after surgery
Presence of side effects First 48 hours Daily scoring of side effects (nausea, drowsiness, pruritus, other (yes/no))
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
Trial Locations
- Locations (1)
St Antonius Hospital
🇳🇱Nieuwegein, Utrecht, Netherlands