Erector Spinae Plane Block
Conditions
Keywords
percutaneous balloon kyphoplasty, erector spinae plane block, Postoperative Pain, local anesthesia
Brief summary
Patients, older than 50 years, with vertebral fracture scheduled for percutaneous balloon kyphoplasty will be enrolled for the study. Some patients will be under local anesthesia with sedation and analgesia for the procedure. Some patients will be performed erector spinae plane block with the guidance of ultrasonography for the procedure. The investigators aim to evaluate the intraoperative and postoperative analgesic requirement of patients. Surgeon's and patients' satisfaction will be also evaluated.
Detailed description
Patients, older than 50 years, American Society of Anesthesiologists physical status I, II, III and IV and scheduled for percutaneous balloon kyphoplasty due to osteoporotic vertebra fracture will be enrolled for this prospective, observational study. Written consent will be taken from all patients. All patients will be taken to the premedication room. Standard monitorization will be performed with electrocardiography, non-invasive blood pressure and pulse oximeter. A 20 Gauge intravenous (iv) canula will be inserted and 10-20 mg/kg iv crystalloid infusion will be started. According to the neurosurgeon's preference patients will be under local anesthesia with sedation and analgesia or erector spinae plane block and sedation during the procedure. In Group Local Anesthesia (L), local anesthesia with 0.25% 20 mL bupivacaine will be given extrapedicular part of the fractured vertebra by the surgeon. At the same time, intravenous 0.1 mg/kg midazolam, 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be administered to achieve sedation and analgesia. In Group Erector Spinae Plane Block (ESP), bilateral erector spinae plane block will be performed at the level of fractured vertebra with totally 40 mL 0.25% bupivacaine under ultrasound imaging by the anesthesiologist. 20 minutes after administration of the block, the surgical procedure will be started. During the procedure intravenous 0.1 mg/kg midazolam will be administered for sedation. Pain will be assessed with numeric rating scale (NRS). When NRS is 4 or over 4, additional 0.3 mg/kg ketamine and 25-100 mcg/kg/min propofol will be given intravenously. In the postoperative period all patients in groups, NRS will be also used to assess the pain. When NRS is 4 or over 4, 1 gr paracetamol will be given intravenously. If NRS will not be under 4 after 1 hour of paracetamol administration, iv 1 mg/kg tramadol will be given. Postoperative and intraoperative opioid consumption will be assessed to evaluate the effectiveness of erector spinae plane block. Surgeon's and patients satisfaction will be assessed with 5 points Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied. All outcome measures will be statistically analyzed.
Interventions
OTHERErector spinae plane block
Local anesthetic solution (40 mL 0.25% bupivacaine totally) will be given bilaterally between the processus transversalis of the fractured vertebra and the erector spinae muscle under ultrasound imaging by an anesthesiologist.
OTHERLocal anesthesia
Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.
Sponsors
Bozyaka Training and Research Hospital
Study design
Observational model
CASE_CROSSOVER
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
50 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* American Society of Anesthesiologists physical status I, II, III, IV * Pathologic vertebra fracture * Percutaneous balloon kyphoplasty for single vertebrae
Exclusion criteria
* Contraindications for plane blocks (bleeding disorder, infection on the injection side) * Hemodynamic instability * Pregnancy * Patient's refusal * Vertebra fracture due to trauma * Multiple vertebra fractures * Procedure under general anesthesia * Allergy to local anesthetics
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Opioid consumption during surgery | Within first hour of the surgical procedure | Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure. |
| Opioid consumption after surgery | Up to 24 hours after the surgical procedure | Opioid consumption will be assessed with the need of opioid analgesics after the surgery. |
| Pain during surgical procedure | Within the first hour of the surgical procedure | Pain during the surgical procedure will be assessed by using numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4 additional opioid analgesic will be given to the patient intravenously. |
| Pain after surgical procedure | Up to 24 hours after the surgical procedure | Pain will be assessed with numeric rating scale (NRS). NRS is between 0 and 10, where 0 is no pain and 10 is the worst pain. When the NRS is 4 or over 4, additional opioid analgesic will be given to the patient intravenously. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon's satisfaction | Within 24 hours of the surgical procedure | The surgeon will assess the ease of the procedure and patient's comfort during the procedure with Likert's scale; 1: very dissatisfied, 2: dissatisfied, 3: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied |
| Patient's satisfaction | Within 24 hours of the surgical procedure | Patient will assess the comfort during intraoperative and postoperative period with Likert's scale 1: very dissatisfied, 2: dissatisfied, 4: neither dissatisfied or satisfied, 4: satisfied, 5: very satisfied |
Countries
Turkey (Türkiye)
Outcome results
None listed