Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06539143
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-04-14
Brief Title:
Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Analgesia From Conscious Sedation Versus Paracervical Block for Manual Vacuum Aspiration for First Trimester Incomplete Miscarriage in Abakaliki A Randomized Trial
Status:
COMPLETED
Status Verified Date:
2024-08
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:
Miscarriage is one of the major causes of early pregnancy losses Incomplete miscarriage is a major cause of maternal morbidity and mortality Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital Abakaliki AEFUTHA
Detailed Description:
SUMMARY
Background
First trimester pregnancy losses are estimated to occur in 14-19 of all clinically confirmed pregnancies and account for about 80 of all the pregnancy losses Miscarriage is one of the major causes of early pregnancy losses Incomplete miscarriage is a major cause of maternal morbidity and mortality
Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage In my center conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness weakness etc there is a shift to paracervical block hence this study
Objectives
The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital Abakaliki AEFUTHA
Methodology
This was a randomized control trial equivalent study that compared the analgesia from conscious sedation with that of the paracervical block in women selected for manual vacuum aspiration following first trimester incomplete miscarriage in AEFUTHA Patients were categorized into groups A and B Those in group A received conscious sedation using intravenous diazepam 10 mg and intravenous pentazocine 30 mg stat while those in the other group B received paracervical block via the use of 10ml of 1 lidocaine with 4ml at 400 clock and 800 clock respectively and 2ml at the anterior lip of the cervix After analgesic effect has occurred manual vacuum aspiration was done and there after pain assessment was be carried out at 10 mins 2 hours 6 hours 12 hours and 24 hours respectively The vital signs and oxygen saturation pre and post operatively were monitored with chart kept for analysis
Analysis
The data were analyzed using Spss version 280 2022 Continuous variables were compared with t- test while categorical variables were compared with Chi- square and the p-value determined P- value less than 005 was taken to be statistically significant
Background
First trimester pregnancy losses are estimated to occur in 14-19 of all clinically confirmed pregnancies and account for about 80 of all the pregnancy losses Miscarriage is one of the major causes of early pregnancy losses Incomplete miscarriage is a major cause of maternal morbidity and mortality
Analgesia from both conscious sedation and paracervical could be utilized during manual vacuum aspiration of first trimester incomplete miscarriage In my center conscious sedation is mostly used but because of the pronounced systemic side effect of drowsiness weakness etc there is a shift to paracervical block hence this study
Objectives
The objectives of this study are to review the existing studies and to compare analgesia from conscious sedation with that of paracervical block among women selected for manual vacuum aspiration following first trimester incomplete miscarriages in Alex Ekwueme Federal University Teaching Hospital Abakaliki AEFUTHA
Methodology
This was a randomized control trial equivalent study that compared the analgesia from conscious sedation with that of the paracervical block in women selected for manual vacuum aspiration following first trimester incomplete miscarriage in AEFUTHA Patients were categorized into groups A and B Those in group A received conscious sedation using intravenous diazepam 10 mg and intravenous pentazocine 30 mg stat while those in the other group B received paracervical block via the use of 10ml of 1 lidocaine with 4ml at 400 clock and 800 clock respectively and 2ml at the anterior lip of the cervix After analgesic effect has occurred manual vacuum aspiration was done and there after pain assessment was be carried out at 10 mins 2 hours 6 hours 12 hours and 24 hours respectively The vital signs and oxygen saturation pre and post operatively were monitored with chart kept for analysis
Analysis
The data were analyzed using Spss version 280 2022 Continuous variables were compared with t- test while categorical variables were compared with Chi- square and the p-value determined P- value less than 005 was taken to be statistically significant
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