Comparative Study of Hyperbaric Bupivacaine plus Ketamine vs. Bupivacaine plus Fentanyl for Spinal Anesthesia during Cesarean Section.

Comparative Study of Hyperbaric Bupivacaine plus Ketamine vs. Bupivacaine plus Fentanyl for Spinal Anesthesia during Cesarean Section. A prospective , Randomized , Double -Blind, controlled study in pregnant women with age (18-45) years old.

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12624001209583

Enrollment

105

Registered

2024-10-02

Start date

2020-06-07

Completion date

2020-09-17

Last updated

2024-10-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

this study was administered Preservative-free ketamine 15 mg plus bupivacaine 10 mg (Marcaine) 0.5%, and in the B group bupivacaine 10 mg (Marcaine) 0.5% alone, Our hypothesis is that there are a significant relationship between the duration of analgesia, length of sensory and motor blockade between ketamine, fentanyl, and bupivacaine groups intraoperative and post-operative.

Interventions

Interventional group was administered Preservative-free ketamine 15 mg plus bupivacaine 10 mg (Marcaine) 0.5%, and in the B group was administered bupivacaine 10 mg (Marcaine) 0.5% alone. The strategies we’re used to evaluate the patient through self monitoring and closed observation. An anesthesiologist performed the spinal puncture by pencil-point spinal needle (27 Fr) between the L3 to L4 or L4–L5 vertebrae with the patient in a sitting position on the side of the operation table.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Blinded (masking used) (Subject, Caregiver)

Eligibility

Sex/Gender

All

Age

18 Years to 45 Years

Healthy volunteers

Inclusion criteria

A pregnant women with age (18-45) years old and planned for elective cesarean sections delivery with ASA Classification I &II, at specialized Arab hospital.

Exclusion criteria

Pregnant women with spinal block contraindications and those with a history of ketamine medication allergies.

Outcome results