Izmir Bozyaka Training and Research Hospital
Izmir, Turkey (Türkiye)
NCT Number: NCT05970380
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.
Looking for future studies?
Notify Me50 year–80 year
All sexes
Observational
Izmir, Turkey (Türkiye)
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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.
Local anesthetic solution (20 mL 0.25% bupivacaine) will be given extrapedicular part of the fractured vertebra by the surgeon.
Time frame: Within first hour of the surgical procedure
Opioid consumption will be assessed with the need of opioid analgesics and propofol during the surgical procedure.
Time frame: Up to 24 hours after the surgical procedure
Opioid consumption will be assessed with the need of opioid analgesics after the surgery.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: 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
Bozyaka Training and Research Hospital
Other
Evaluation of the Effect of Erector Spinae Plane Block on Analgesic Consumption in Patients Scheduled for Percutaneous Balloon Kyphoplasty; Prospective Observational Study
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
Published trials that share one or more normalized conditions with this study.
NCT07509957
Erector Spinae Plane Block, Inguinal Hernia Unilateral
Sanliurfa, Eyyübiye, Turkey (Türkiye)
View Trial DetailsNCT05083832
Erector Spinae Plane Block, Neurologic Manifestations
Keçiören, Ankara, Turkey (Türkiye)
View Trial DetailsNCT06257953
Acute Pain, Body Mass Index
Yenimahalle, Ankara, Turkey (Türkiye)
View Trial DetailsNCT07418671
Erector Spinae Plane Block, Neurologic Manifestations
Cairo, Cairo Governorate, Egypt
View Trial Details