The Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section

Ain Shams University

Status: Enrolling

Conditions: Cesarean Section; Analgesia; Post Operative Pain

Treatments: Drug: standard multimodal analgesia; Drug: multimodal analgesia and vitamin B

Study type: Interventional

Funder types: Other

Identifiers

NCT06446830

FMASU R370/2023

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: Female

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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100 participants in 2 patient groups

vitamin B

Experimental group

Description:

oral vitamin B complex tablets preoperative and continue post-operative for 2 days One tablet oral once daily for 1- 2 days according to the length of stay; the tablet is a vitamin (B1, B6, B9, and B12). Oral daily vitamin B concentration; Tablet is composed of ; B1= 250mg, B6= 150 mg, B12= 0,250 mg, B9= 0.5mgm, B2 15 mg standard analgesic ladder will be implemented in the form of; Paracetamol 1gram (2 tablets) / 8hr for 48 hours, Ketorolac 30 mg / 12 hour for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented. the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage

Treatment:

Drug: multimodal analgesia and vitamin B

standard

Active Comparator group

Description:

patients will receive a preoperative; Oral placebo tablet (once/day) Post-operative and continue post-operative for 2 days; One placebo capsule oral once daily for 2 days. standard analgesic ladder will be implemented in the form of; Paracetamol 1 gram (2 tablets) / 8hr for 48 hours. Ketorolac / 12 hours for 48 hours. Any pain will be treated appropriately with nalbuphine till the patient is comforted, and the total dose will be documented. the routine ladder of paracetamol and ketorolac will be modified according to organ functions and the presence of any contraindication for usage

Treatment:

Drug: standard multimodal analgesia