Analgesia, Cesarean Section, Post Operative Pain
Conditions
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 (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.
Interventions
DRUGmultimodal analgesia and vitamin B
B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
Routine Paracetamol and NSAID
Sponsors
Ain Shams University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
the candidate will be masked, and Assessments regarding the primary outcome will be conducted by an assessor blind to treatment allocation. The assessor will go through a profound assessment training program
Intervention model description
two parallel-group, randomized, double-blinded
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
No
Inclusion criteria
* Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia.
Exclusion criteria
1. Patient's Refusal to participate 2. Known allergy to one or more of the given components. 3. Disturbed conscious level. 4. Prolonged or complicated surgery; defined by operative time of more than 90 min. 5. Severe liver dysfunction or failure 6. Severe renal dysfunction or failure. 7. Severe thrombocytopenia; platelets less than 50
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The total consumption of rescue analgesics in the first and second 24 hours after delivery | 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 |
| Pain score assessed by numerical pain scale after 24 hours from delivery. | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| quality of recovery on discharge from ICU | 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 |
| occurrence of any side effects | during ICU stay and no more than 48 hours post-caesarean section | occurrences of any side effects as allergy |
Countries
Egypt
Contacts
Primary Contactwessam selima, MD
Backup Contactwessam Z mohamed
Outcome results
None listed