Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06640816
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-25
Brief Title:
Bupivacaine Effectivity and Efficiency for Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effectiveness ampamp Efficiency of Bupivacaine Regional Spinal Anesthesia in Non-ERACS and ERACS Caesarean Section Based on Height and BMI
Status:
COMPLETED
Status Verified Date:
2024-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The most widely used regional anesthesia technique in Indonesia today is regional anesthesia with the subarachnoid spinal blockade method In its development this technique is not only used for surgery in the lower abdomen area but also used as a management of acute pain Especially for cases of pregnant patients undergoing cesarean section in its development a method known as enhanced regional anesthesia for c-section ERACS emerged
This technique is widely preferred by most patients ERACS is considered very beneficial for patients because this technique promises faster mobility after surgery with a longer duration of pain compared to conventional spinal regional anesthesia techniques
The data collected from this study is secondary data derived from the medical records of patients in 2 private hospitals in Purbalingga Regency which are taken and sorted systematically according to needs
This study was conducted based on the situation and condition of health services in Indonesia which are highly dependent on state funding through the national health insurance system The state funding emphasizes the effectiveness and efficiency of health services including surgical and related procedures
The question of this research
1 Is Bupivacaine in ERACS patients better than Non-ERACS based on BMI and height
2 Is Bupivacaine in ERACS patients more effective and efficient than Non-ERACS based on BMI and height
This technique is widely preferred by most patients ERACS is considered very beneficial for patients because this technique promises faster mobility after surgery with a longer duration of pain compared to conventional spinal regional anesthesia techniques
The data collected from this study is secondary data derived from the medical records of patients in 2 private hospitals in Purbalingga Regency which are taken and sorted systematically according to needs
This study was conducted based on the situation and condition of health services in Indonesia which are highly dependent on state funding through the national health insurance system The state funding emphasizes the effectiveness and efficiency of health services including surgical and related procedures
The question of this research
1 Is Bupivacaine in ERACS patients better than Non-ERACS based on BMI and height
2 Is Bupivacaine in ERACS patients more effective and efficient than Non-ERACS based on BMI and height
Detailed Description:
This study was conducted at 2 hospitals in Purbalingga Regency and is a routine procedure carried out by researchers since 2015 and collected gradually from January to December 2023 The purpose of this study was to see the effectiveness and efficiency of several standard procedures carried out by the author for several years on post-spinal anesthesia complications and the duration of mobilization In general the effectiveness and efficiency of an action will lead to costs This study was divided into 4 groups namely the dose group based on height and weight with the ERACS method A1 the dose group based on height and weight non-ERACS A2 the dose group not based on height and weight with the ERACS method K1 and the dose group not based on height and weight non-ERACS K2 The total sample used was 150 which was divided into 2 namely 100 cases based on height and weight and 50 cases not based on height and weight The sampling technique used the purposive sampling method The study was conducted during January - December 2023
This study compared the effectiveness between groups as seen from postoperative hemodynamics blood pressure and pulse duration of pain relief and the use of perioperative resuscitation drugs ephedrine based on the patient39s height and weight In patients in groups A1 and A2 the administration of 05 bupivacaine is when the height is gt 150 cm then the dose of bupivacaine is 10 mg and if the height is more than 160 cm then the dose of bupivacaine is 15 mg In groups K1 and K2 the administration of 05 bupivacaine is 20 mg All statistical analyses were performed using IBM SPSS Statistics Software Version 20 The statistical tests used were the Wilcoxon Signed Ranks Test and the Kruskal Wallis Test adjusted to the needs and type of data Data is considered significant if the p value is less than 005
This study compared the effectiveness between groups as seen from postoperative hemodynamics blood pressure and pulse duration of pain relief and the use of perioperative resuscitation drugs ephedrine based on the patient39s height and weight In patients in groups A1 and A2 the administration of 05 bupivacaine is when the height is gt 150 cm then the dose of bupivacaine is 10 mg and if the height is more than 160 cm then the dose of bupivacaine is 15 mg In groups K1 and K2 the administration of 05 bupivacaine is 20 mg All statistical analyses were performed using IBM SPSS Statistics Software Version 20 The statistical tests used were the Wilcoxon Signed Ranks Test and the Kruskal Wallis Test adjusted to the needs and type of data Data is considered significant if the p value is less than 005
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None