Ignite Creation Date:
2024-06-16 @ 11:50 AM
Last Modification Date:
2024-10-26 @ 3:31 PM
Study NCT ID:
NCT06446830
Status:
RECRUITING
Last Update Posted:
2024-07-09
First Post:
2024-06-02
Brief Title:
the Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section
Sponsor:
Ain Shams University
Organization:
Ain Shams University
Study Overview
Official Title:
the Analgesic Efficacy of Vitamin B Complex With Paracetamol and Non-steroidal Antiinflammatory Medication in Critically Ill Obstetrics After Caesarian Section A Prospective Randomized Placebo-controlled and Double-blinded Study
Status:
RECRUITING
Status Verified Date:
2024-05
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:
We aim to investigate the value of vitamin B B1 B6 B9 B12 on post-cesarean section analgesia in addition to the standard opioid-sparing multimodal regimen to achieve more robust analgesia with minimal side effects
Detailed Description:
Optimum analgesia is an essential component in enhanced recovery after elective and emergency Caesarean section Opioid-based analgesia negatively affects maternal functional recovery Unlike other types of surgeries the performance and the quality of postoperative recovery in caesarean section affects two individuals the patient and their infant hence it is recommended to use Opioid-sparing medications post-caesarean section
Multimodal analgesia is recommended for post-caesarean section pain control The main properties of its components are to promote return of i Mobility ii Oral intake iii Normal bowel function iv Micturition Trial without urinary catheter v Activities of daily living with Few adverse effects inactive metabolites no nausea vomiting sedation pruritus constipation or respiratory depression Readily available after discharge home Little risk of dependency especially long-term opioids Minimal risk of hyperalgesia or chronic pain and cost-efficient with minimally invasive technique and no side-effects on the neonate
The morbidity of critically ill obstetrics can increase due to inadequate control of pain and also due to the consumption of opioid analgesia due to associated respiratory depression sedation and nausea Multimodal analgesia is strongly recommended
An immune-histochemistry study found that B vitamins potentiate acute morphine antinociception In other studies the value of vitamin B complex on postoperative analgesia was discussed and investigated in different combinations Another study reported the value of folic acid in decreasing gastric hypersensitivity in maternal stress in rats Other studies explained the benefit of folic acid in analgesia through modulating gut microbiota reducing inflammation modulating purinergic signaling and promoting nerve repair 6This is the first study to investigate the effect of vitamin B9 folic acid and other vitamin B B1 B6 B12 beside the standard opioid sparing analgesics on post-caesarean section pain in critically ill obstetrics
Multimodal analgesia is recommended for post-caesarean section pain control The main properties of its components are to promote return of i Mobility ii Oral intake iii Normal bowel function iv Micturition Trial without urinary catheter v Activities of daily living with Few adverse effects inactive metabolites no nausea vomiting sedation pruritus constipation or respiratory depression Readily available after discharge home Little risk of dependency especially long-term opioids Minimal risk of hyperalgesia or chronic pain and cost-efficient with minimally invasive technique and no side-effects on the neonate
The morbidity of critically ill obstetrics can increase due to inadequate control of pain and also due to the consumption of opioid analgesia due to associated respiratory depression sedation and nausea Multimodal analgesia is strongly recommended
An immune-histochemistry study found that B vitamins potentiate acute morphine antinociception In other studies the value of vitamin B complex on postoperative analgesia was discussed and investigated in different combinations Another study reported the value of folic acid in decreasing gastric hypersensitivity in maternal stress in rats Other studies explained the benefit of folic acid in analgesia through modulating gut microbiota reducing inflammation modulating purinergic signaling and promoting nerve repair 6This is the first study to investigate the effect of vitamin B9 folic acid and other vitamin B B1 B6 B12 beside the standard opioid sparing analgesics on post-caesarean section pain in critically ill obstetrics
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?:
False
Is an FDA AA801 Violation?:
None