The efficacy of two bupivacaine hydrochloride injection products.
OBJECTIVE
The relative efficacy of two bupivacaine hydrochloride injection products was investigated in patients who were undergoing intra-ocular eye surgery.


METHODS
Patients took part in this double-blind, randomised, parallel-group study and received either Macaine (Keatings) or Regibloc (Intramed), according to the randomisation schedule.


METHODS
The study was carried out in the ophthalmology operating theatres of National and Pelonomi Hospitals, Bloemfontein, South Africa.


METHODS
Thirty male and 74 female patients who needed extra-capsular lens extraction plus intra-ocular lens implantation, extra-capsular lens extraction, or trabeculectomy were selected for the study.


METHODS
Akinesia was evaluated after 10, 15 and 20 minutes. In the event of incomplete akinesia after 20 minutes, an additional injection was administered, and after 5 minutes another evaluation of akinesia was done. Anaesthesia was evaluated at the beginning of surgery.


RESULTS
The proportions of patients who received no additional anaesthesia were 57.7% for Macaine and 70.8% for Regibloc (difference 13.1%, 95% confidence interval (CI) -5.5 - 31.7%). The proportions of patients with adequate akinesia (possibly after additional anaesthesia) were 90.4% for Macaine and 89.6% for Regibloc (difference -0.8%, 95% CI-12.6 - 11.0%). The proportions of patients experiencing no pain or discomfort at the beginning of surgery were 88.2% for Macaine and 87.5% for Reglibloc (difference -0.7%, 95% CI-13.6 - 12.1%).


CONCLUSIONS
The study results indicate that Regibloc is at least as effective as, or superior to, Macaine in achieving adequate akinesia.
Müller
F O
FO
FARMOVS Research Centre for Clinical Pharmacology and Drug Development, Bloemfontain.
Claasen
J P
JP
Schall
R
R
Mogilnicka
E M
EM
Vos
D J
DJ
Groenewoud
G
G
Middle
M V
MV
Stulting
A A
AA
D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000779:Anesthetics, Local / Q000008:administration & dosage; D002045:Bupivacaine / Q000008:administration & dosage; D004311:Double-Blind Method; D005123:Eye; D005260:Female; D006801:Humans; D007267:Injections; D008297:Male; D008875:Middle Aged; D013508:Ophthalmologic Surgical Procedures; D013019:South Africa
D000779:Anesthetics, Local; D002045:Bupivacaine