Ain shams university
Cairo, Egypt, 11591
Location status: Recruiting
NCT Number: NCT06446830
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.
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Interventional
Not applicable
Cairo, Egypt, 11591
Location status: Recruiting
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 (6)This 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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
Other names: neuroton tablets
Routine Paracetamol and NSAID
Time frame: in the first 24 hours and in the second 24 hours (if stay is extended )
the difference in mean of the total amount consumed of paracetamol, ketorolac and nalbuphine
Time frame: 24 hours postoperative
By using a s scale from 0-10 where zero is no pain and 10 is the worst pain, the scale willbe used 24 hours postoperative . results will be compared between both groups
Time frame: on discharge from ICU ( or within 48 hours post operative ) which is shorter
using The Obstetric Quality of Recovery-10A questionnaire where less than 70 will be considered poor recovery , and the higher the score will be linked to better recovery
Time frame: during ICU stay and no more than 48 hours post-caesarean section
occurrences of any side effects as allergy
Contact information is provided by the study sponsor or research team.
wessam Z mohamed
CONTACT
wessam selima, MD
CONTACT
Ain Shams University
Other
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
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