Ignite Creation Date:
2024-06-16 @ 11:51 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06441071
Status:
RECRUITING
Last Update Posted:
2024-06-04
First Post:
2024-05-08
Brief Title:
Patients Positions on Analgesic Efficacy of ESPB
Sponsor:
Nanjing First Hospital Nanjing Medical University
Organization:
Nanjing First Hospital Nanjing Medical University
Study Overview
Official Title:
Effect of Different Patients Positions on Postoperative Analgesia of Ultrasound-guided Erector Spinae Plane Block
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to learn if patients remaining different positions for 30min after receiving ultrasound-guided erector spinae plane block influenced the postoperative analgesia The main questions it aims to answer are
Does patients maintain prone position or lateral position for 30 min after ESPB provided superior analgesic effect than in the supine position Is ESPB not inferior to PVB considering postoperative opioid consumption Researchers will compare the opioid consumption 24h postoperatively among the patients remaining supine lateral prone position after ESPB and PVB to see if patients maintaining lateral or prone position provided excellent postoperative analgesia
Participants will
Maintaining supine lateral or prone position for 30 min following ESPB or receiving PVB
Receiving postoperative NRS and QoR assessment
Does patients maintain prone position or lateral position for 30 min after ESPB provided superior analgesic effect than in the supine position Is ESPB not inferior to PVB considering postoperative opioid consumption Researchers will compare the opioid consumption 24h postoperatively among the patients remaining supine lateral prone position after ESPB and PVB to see if patients maintaining lateral or prone position provided excellent postoperative analgesia
Participants will
Maintaining supine lateral or prone position for 30 min following ESPB or receiving PVB
Receiving postoperative NRS and QoR assessment
Detailed Description:
After signed the informed consent form 200 patients scheduled for elective thoracoscopic surgery were randomly divided into four groups supine position group group S n 50 prone position group group P n 50 lateral position group group L n 50 and paravertebral block group group C n 50 After ESPB block the corresponding position was maintained for 30 minutes
Ultrasound-guided ESPB was performed 30min before general anesthesia Ultrasound-guided ESPB methods The ultrasonic high-frequency linear array probe 5-13 MHZ Sonosite USA was placed parallel to the spine on the surface of the transverse process tip of the fifth thoracic vertebra Under ultrasound the transverse process and the surface of the erector spinae were clearly exposed Then a long beved-plane needle was used and the needle was inserted from the head side 2ml of normal saline was injected using the water separation technique to confirm the position of the needle tip and then 30ml 0375 ropivacaine was injected
After completion of the block patients in group S were kept in the supine position for 30min patients in group L were kept in the upper lateral position for 30min and patients in group P were kept in the prone position for 30min After 30 minutes of observation an anesthesiologist who was unaware of the grouping used an ice cube to determine the extent of sensory block General anesthesia was then performed
General anesthesia was performed as follows routine ECG monitoring was performed after the patient was admitted to the operating room and invasive arterial blood pressure was monitored by radial artery puncture and catheterization General anesthesia was induced with dexamethasone 10mg midazolam 005mgkg-1 propofol 15-20 mgkg-1 sufentanil 02 ugkg-1 cisatracurium 02 mgkg-1 and then a double-luminal bronchial tube was inserted under a video laryngoscope and mechanically ventilated tidal volume 6mlkg-1PEEP 3-5 cm H2O Anesthesia was maintained with propofol 2-4 mgkg-1h-1 remifentanil 012-02 mgkg-1min-1 and Micuronium 06mgkg-1h-1 Intraoperative hemodynamics was maintained within 20 of baseline Flurbiprofen axetil 50mg was given intravenously for analgesia and tropisetron 4mg was given to prevent nausea and vomiting when there were no contraindications during the operation Intraoperative infusion was limited to 6mlkg-1h-1 Oxycodone 3mg was administered intravenously 30min before the end of the procedure At the end of the operation the patient was transferred to PACU with an endotracheal tube After neuromuscular blocking antagonism the tracheal tube was extubated
NRS was used to evaluate the pain scores at rest and during movement at 1 3 6 12 and 24h 48h after operation by a nurse who was unaware of the grouping Oxycodone 30mg diluted to 150ml was used for patient-controlled intravenous analgesia after operation The parameters of analgesia pump were set as background dose 05 mlh-1 bolus 5ml lockout time 8min If NRS4 at rest after surgery patient-controlled analgesia PCA was performed by pressing the PCA pump When NRS4 at rest was still 4 after two times of PCA oxycodone 1mg was given once as rescue analgesia and the patients were reevaluated until NRS3
Ultrasound-guided ESPB was performed 30min before general anesthesia Ultrasound-guided ESPB methods The ultrasonic high-frequency linear array probe 5-13 MHZ Sonosite USA was placed parallel to the spine on the surface of the transverse process tip of the fifth thoracic vertebra Under ultrasound the transverse process and the surface of the erector spinae were clearly exposed Then a long beved-plane needle was used and the needle was inserted from the head side 2ml of normal saline was injected using the water separation technique to confirm the position of the needle tip and then 30ml 0375 ropivacaine was injected
After completion of the block patients in group S were kept in the supine position for 30min patients in group L were kept in the upper lateral position for 30min and patients in group P were kept in the prone position for 30min After 30 minutes of observation an anesthesiologist who was unaware of the grouping used an ice cube to determine the extent of sensory block General anesthesia was then performed
General anesthesia was performed as follows routine ECG monitoring was performed after the patient was admitted to the operating room and invasive arterial blood pressure was monitored by radial artery puncture and catheterization General anesthesia was induced with dexamethasone 10mg midazolam 005mgkg-1 propofol 15-20 mgkg-1 sufentanil 02 ugkg-1 cisatracurium 02 mgkg-1 and then a double-luminal bronchial tube was inserted under a video laryngoscope and mechanically ventilated tidal volume 6mlkg-1PEEP 3-5 cm H2O Anesthesia was maintained with propofol 2-4 mgkg-1h-1 remifentanil 012-02 mgkg-1min-1 and Micuronium 06mgkg-1h-1 Intraoperative hemodynamics was maintained within 20 of baseline Flurbiprofen axetil 50mg was given intravenously for analgesia and tropisetron 4mg was given to prevent nausea and vomiting when there were no contraindications during the operation Intraoperative infusion was limited to 6mlkg-1h-1 Oxycodone 3mg was administered intravenously 30min before the end of the procedure At the end of the operation the patient was transferred to PACU with an endotracheal tube After neuromuscular blocking antagonism the tracheal tube was extubated
NRS was used to evaluate the pain scores at rest and during movement at 1 3 6 12 and 24h 48h after operation by a nurse who was unaware of the grouping Oxycodone 30mg diluted to 150ml was used for patient-controlled intravenous analgesia after operation The parameters of analgesia pump were set as background dose 05 mlh-1 bolus 5ml lockout time 8min If NRS4 at rest after surgery patient-controlled analgesia PCA was performed by pressing the PCA pump When NRS4 at rest was still 4 after two times of PCA oxycodone 1mg was given once as rescue analgesia and the patients were reevaluated until NRS3
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None