Clinical trial NCT06446830: The Analgesic Efficacy of Vitamin B Complex in Critically Ill Obstetrics After Caesarean Section
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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Analgesia
Post Operative Pain
Cesarean Section
Lead sponsor: Ain Shams University
Sponsor class: OTHER
First posted: 2024-06-06
Enrollment: 100
Sex: FEMALE
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: two parallel-group, randomized, double-blinded
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: The total consumption of rescue analgesics in the first and second 24 hours after delivery
timeFrame: in the first 24 hours and in the second 24 hours (if stay is extended )
measure: Pain score assessed by numerical pain scale after 24 hours from delivery.
timeFrame: 24 hours postoperative
Secondary outcomes:
measure: quality of recovery on discharge from ICU
timeFrame: on discharge from ICU ( or within 48 hours post operative ) which is shorter
measure: occurrence of any side effects
timeFrame: during ICU stay and no more than 48 hours post-caesarean section
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Ain shams university
Study officials:
affiliation: assistant professor (lecturer)- Ain shams university
name: wessam selima, MD
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Deng XT, Han Y, Liu WT, Song XJ. B Vitamins Potentiate Acute Morphine Antinociception and Attenuate the Development of Tolerance to Chronic Morphine in Mice. Pain Med. 2017 Oct 1;18(10):1961-1974. doi: 10.1093/pm/pnw358.
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