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

Analgesia Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06446830
• Other study ID #: FMASU R370/2023
• Status: Recruiting
• Phase: N/A
• Start date: May 25, 2024
• Est. completion date: October 1, 2024

Study information

• Verified date: May 2024
• Source: Ain Shams University
• Contact: wessam selima, MD
• Phone: 01001958858
• Email: w.z.selima[@]med.asu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: October 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Analgesia
• Cesarean Section
• Pain, Postoperative
• Post Operative Pain

Intervention

Drug:
• multimodal analgesia and vitamin B
B1, B6 , B9 , B12 in addition to the routine paracetamol and NSAID
• standard multimodal analgesia
Routine Paracetamol and NSAID

Locations

Country	Name	City	State
Egypt	Ain shams university	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

References & Publications (4)

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. — View Citation

Kang WB, Chen YJ, Lu DY, Yan JZ. Folic acid contributes to peripheral nerve injury repair by promoting Schwann cell proliferation, migration, and secretion of nerve growth factor. Neural Regen Res. 2019 Jan;14(1):132-139. doi: 10.4103/1673-5374.243718. — View Citation

Neall G, Bampoe S, Sultan P. Analgesia for Caesarean section. BJA Educ. 2022 May;22(5):197-203. doi: 10.1016/j.bjae.2021.12.008. Epub 2022 Mar 8. No abstract available. Erratum In: BJA Educ. 2022 Nov;22(11):448. — View Citation

Wang HJ, Zhang FC, Xu TW, Xu YC, Tian YQ, Wu YY, Xu JT, Hu S, Xu GY. DNMT1 involved in the analgesic effect of folic acid on gastric hypersensitivity through downregulating ASIC1 in adult offspring rats with prenatal maternal stress. CNS Neurosci Ther. 2023 Jun;29(6):1678-1689. doi: 10.1111/cns.14131. Epub 2023 Feb 27. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total consumption of rescue analgesics in the first and second 24 hours after delivery	the difference in mean of the total amount consumed of paracetamol, ketorolac and nalbuphine	in the first 24 hours and in the second 24 hours (if stay is extended )
Primary	Pain score assessed by The Brief Pain Inventory (Short Form) after 12 -24 hours from delivery.	Using the validated Arabic version; the score of the assessment will be done on 12 , 24 hours . the results will be compared among both groups	within 12 and 24 hours postoperative
Secondary	quality of recovery on discharge from ICU	using The Obstetric Quality of Recovery-10 questionnaire	on discharge from ICU ( or within 48 hours post operative ) which is shorter
Secondary	occurrence of any side effects	occurrences of any side effects as allergy	during ICU stay and no more than 48 hours post-caesarean section