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NCT Number: NCT06446830

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

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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Key information

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Ain shams university

Cairo, Egypt, 11591

Location status: Recruiting

Location contact

Anesthesia department

CONTACT

[email protected]

01009499962

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Critically ill -obstetric patients who will be delivered by cesarean section under neuraxial anesthesia.

Exclusion criteria

  • Patient's Refusal to participate
  • Known allergy to one or more of the given components.
  • Disturbed conscious level.
  • Prolonged or complicated surgery; defined by operative time of more than 90 min.
  • Severe liver dysfunction or failure
  • Severe renal dysfunction or failure.
  • Severe thrombocytopenia; platelets less than 50

Treatment and study plan

multimodal analgesia and vitamin B

Drug

B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID

Other names: neuroton tablets

standard multimodal analgesia

Drug

Routine Paracetamol and NSAID

Primary outcomes

  1. The total consumption of rescue analgesics in the first and second 24 hours after delivery

    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

  2. Pain score assessed by numerical pain scale after 24 hours from delivery.

    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

Secondary outcomes

  1. quality of recovery on discharge from ICU

    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

  2. occurrence of any side effects

    Time frame: during ICU stay and no more than 48 hours post-caesarean section

    occurrences of any side effects as allergy

Study contacts

Contact information is provided by the study sponsor or research team.

wessam Z mohamed

CONTACT

[email protected]

01003069492

wessam selima, MD

CONTACT

[email protected]

01001958858

Sponsors and collaborators

Lead sponsor

Ain Shams University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 6, 2024
Registry last updated
Feb 17, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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