Ignite Creation Date:
2024-05-06 @ 8:19 PM
Last Modification Date:
2024-10-26 @ 3:25 PM
Study NCT ID:
NCT06332313
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-03-27
First Post:
2024-03-11
Brief Title:
Erector Spina Plane Block Volume Comparison
Sponsor:
Kahramanmaras Sutcu Imam University
Organization:
Kahramanmaras Sutcu Imam University
Study Overview
Official Title:
Comparison of Patient-Controlled Analgesia and Erector Spina Blocks Applied at Different Volumes in Postoperative Pain Management in Retrograde Intrarenal Surgery Operations
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-03
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:
After obtaining ethical committee approval from Kahramanmaras University Anesthesiology and Reanimation Department and Urology Clinic 60 patients between 18-65 years old who meet ASA I-II classification criteria with body mass index 40 will be informed about this study both verbally and in writing prior to their inclusion in this study using a randomization method according to Helsinki Declaration after obtaining their written consent Patients who cannot give consent due to any reason or have allergy history against local anesthetics or contraindications for peripheral nerve blocks local infectioncoagulopathy etc or psychiatric disorders or receiving antipsychotic drugs will be excluded from this study Routine preoperative evaluation including age height and weight measurements will be performed on all patients at pre-anesthesia clinic
Patients will be randomized into three groups Group K who will receive analgesia with patient-controlled analgesia PCA with tramadol only Group E20 who will receive PCA with 20cc volume of ESP block and Group E30 who will receive PCA with 30cc volume of ESP block After standard general anesthesia induction and endotracheal intubation one of the three analgesic methods will be randomly applied and the surgery will commence All patients will receive patient-controlled analgesia Patients in Group K will not receive any local anesthetic injection When the patient is transferred to the postoperative care unit intravenous PCA device will be attached and pain scores using Visual Analog Scale VAS rated from 0 no pain to 10 worst pain ever experienced at rest and during coughing will be evaluated at 2 4 6 12 18 and 24 hours postoperatively The values will be recorded When the patient experiences pain analgesic agents will be administered according to the patient-controlled analgesia protocol The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded Postoperative QUIPS Quality Improvement in Postoperative Pain Management questionnaire will be administered and side effects such as nauseavomiting or sedation will be noted Additionally patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent very poorpoorfairgoodexcellentwill also be evaluated and recorded
Patients will be randomized into three groups Group K who will receive analgesia with patient-controlled analgesia PCA with tramadol only Group E20 who will receive PCA with 20cc volume of ESP block and Group E30 who will receive PCA with 30cc volume of ESP block After standard general anesthesia induction and endotracheal intubation one of the three analgesic methods will be randomly applied and the surgery will commence All patients will receive patient-controlled analgesia Patients in Group K will not receive any local anesthetic injection When the patient is transferred to the postoperative care unit intravenous PCA device will be attached and pain scores using Visual Analog Scale VAS rated from 0 no pain to 10 worst pain ever experienced at rest and during coughing will be evaluated at 2 4 6 12 18 and 24 hours postoperatively The values will be recorded When the patient experiences pain analgesic agents will be administered according to the patient-controlled analgesia protocol The time of first analgesic requirement and total amount of consumed analgesic agent within 24 hours will be recorded Postoperative QUIPS Quality Improvement in Postoperative Pain Management questionnaire will be administered and side effects such as nauseavomiting or sedation will be noted Additionally patient satisfaction regarding these methods and their willingness for repeat surgery or recommendation level on a scale from poor to excellent very poorpoorfairgoodexcellentwill also be evaluated and recorded
Detailed Description:
None
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