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Randomised controlled trial comparing the spinal sensory level achieved, duration of action and safety of generic (Bupivacaine 0.5% with Dextrose-PharmaQ) versus original bupivacaine (Macaine 0.5% with dextrose-Adcock Ingram) in spinal anaesthesia

Randomised controlled trial comparing the spinal sensory level achieved, duration of action and safety of generic (Bupivacaine 0.5% with Dextrose-PharmaQ) versus original bupivacaine (Macaine 0.5% with dextrose-Adcock Ingram) in spinal anaesthesia

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
PACTR
Registry ID
PACTR201807735986564
Enrollment
72
Registered
2018-07-26
Start date
2018-07-31
Completion date
Unknown
Last updated
2026-09-14

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

Conditions

Anaesthesia

Interventions

Original formulation Adcock Ingram
Generic formulation of bupivacaine

Sponsors

Pireshin Ramdharee
Lead Sponsor

Eligibility

Sex/Gender
Male

Inclusion criteria

Inclusion criteria: Male patients 18 - 50 years old Healthy patients - American Society of Anaesthesiologists physical status grade one and two

Exclusion criteria

Exclusion criteria: Contraindication to spinal anaesthesia Local anaesthetic allergy Patient refusal

Design outcomes

Primary

MeasureTime frame
Comparing the sensory level achieved by generic to the original drug—

Secondary

MeasureTime frame
Comparing the decrease in the sensory level after 30, 60 and 90 minutes;Comparing the side effects observed betwen generic and original drug—

Countries

South Africa

Contacts

Public ContactPireshin Ramdharee

Principle investigator

pireshin87@gmail.com+27845065211

Outcome results

None listed

Source: PACTR (via WHO ICTRP) · Data processed: Sep 19, 2026