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

NCT06446830 | Recruiting

• 1 other identifier: FMASU R370/2023
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Analgesia; Post Operative Pain; Cesarean Section

Outcome Measures

Primary Outcomes (2)

• 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 )

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

  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

  24 hours postoperative

Secondary Outcomes (2)

• quality of recovery on discharge from ICU

  on discharge from ICU ( or within 48 hours post operative ) which is shorter

• occurrence of any side effects

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

Study Arms (2)

vitamin B

EXPERIMENTAL

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

Drug: multimodal analgesia and vitamin B

standard

ACTIVE COMPARATOR

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

Drug: standard multimodal analgesia

Interventions

multimodal analgesia and vitamin B DRUG

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

Also known as: neuroton tablets

vitamin B

standard multimodal analgesia DRUG

Routine Paracetamol and NSAID

standard

Eligibility Criteria

• Sex: female
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ain Shams University: lead

Study Sites (1)

Ain shams university

Cairo, Egypt, 11591, Egypt

RECRUITING

Related Publications (4)

• Dautzenberg B, Truffot-Pernot C, Hazebroucq J, Legris S, Guerin C, Begelman C, Guermonprez G, Fievet MH, Chastang C, Grosset J. A randomized comparison of two clarithromycin doses for treatment of Mycobacterium avium complex infections. Infection. 1997 Jan-Feb;25(1):16-21. doi: 10.1007/BF02113501.

  PMID: 9039532 BACKGROUND

• 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.

  PMID: 28379583 BACKGROUND

• Moskowitz DB. Marketplace. How the stock market fall hits health care firms. Faulkner Grays Med Health. 1997 Nov 3;51(43):suppl 2 p.. No abstract available.

  PMID: 10173708 BACKGROUND

• Wong TC, Lai MM. Avian reticuloendotheliosis virus contains a new class of oncogene of turkey origin. Virology. 1981 May;111(1):289-93. doi: 10.1016/0042-6822(81)90674-7. No abstract available.

  PMID: 6263007 BACKGROUND

MeSH Terms

Conditions

Agnosia; Pain, Postoperative

Interventions

Folic Acid

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Postoperative Complications; Pathologic Processes; Pain

Intervention Hierarchy (Ancestors)

Pterins; Pteridines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• wessam selima, MD

  assistant professor (lecturer)- Ain shams university

  PRINCIPAL INVESTIGATOR

Central Study Contacts

wessam selima, MD

CONTACT

01001958858; w.z.selima@med.asu.edu.eg

wessam Z mohamed

CONTACT

01003069492; w.z.selima@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: two parallel-group, randomized, double-blinded

Study Record Dates

• First Submitted: June 2, 2024
• First Posted: June 6, 2024
• Study Start: May 25, 2024
• Primary Completion: November 1, 2025
• Study Completion: December 1, 2025
• Last Updated: February 17, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)