Claasen, J.P.

du T. Vas, J.

Groenewoud, G.

Middle, M.V.

Mogilnicka, E.M.

Muller, F.O.

Schall, R.

Stulting, A.A.

English

AJOL - African Journals Online

situation. Appropriate explanation in these circumstancesshould satisfy most parents.In conciusion, this survey has shown that the majority ofsouthern African anaesthetists who responded to the surveywould be happy to allow parents to be present at the timeof induction. However, this practice seems to be hamstrungby 'hospital policy' mediated through the nursing staff.Logistical problems can be overcome with a positiveattitude. The decision to allow a parent who wishes toaccompany a child to the operating theatre to do so shouldrest solely with the anaesthetist, who should be free todiscuss the possibility with the parent, assess the level ofparental anxiety, and act accordingly. Appropriatelyconcerned parents should be allowed to accompany theirchildren if they wish, while over-anxious parents should beexcluded and receive counselling and support. Parentsshould be discouraged, with an appropriate explanation,from accompanying the very young or critically ill child,particularly in an emergency situation_The authors wish to thank Boots Pharmaceuticals (Ply) Ltd,who sponsored the survey, Or Neale du Plooy, editor ofEducation in Anaesthesia, for mailing the survey, andMrs A. Pillay for her secretarial assistance.REFERENces1. While A. Personal view. BMJ 1985; 291: 343.2. Black GW, Bush GH. Morris P. Paediatric anaesthesia. BMJ 1955; 291: ~2.3. Pinkenon P. Preventil'9 psychotrauma in childhood anaestheSIa. In: JacksonRees G. Gny TC. eds. PaeriUlllric AIlaesUleSlll.· Trends In Cvrrenr PraC!lce.London: BlJtlerwol'ths, 1981: 1-18.4. Eckenhoff JE. Relationship of anaesthesia to postoperative personality changesin children. Am J Dis Child 1953: 86: 587·591.5. Meursing AEE. Psychological effec!s 01 anaesthesia in chIldren. CUrT OplnAnaestheSiol 1989; 2: 335·338.6 HannaJlah RS, AbramowilZ MO. Oh TH, RUlllmann UE. Residents' attitudestoward parents' presence during anaesthesia induction in children: doesexperience make a difference? Anesthesiology 1984; 60: 595-601.7. Du Plooy N. ed. Education In Anaesthesia and Critical Care 1991; 3 (2): suppl(Preloria: Specialist Publications).8. Schulman JL, Foley JM, Vernon OTA. Alien O. A study of the effecl 01 themother's presence during anaesthesia Induction. Pediarncs 1967; 39: 111-114.9. Vernon OTA, Schulman JL Hospitalisation as a source 01 psychological benefitfor children. PetjialnCs 1964: 34: 69~-696.10. HannaJlah AS. Rosales JK. ~perienceWith parents' presence dunn.g anaeslheSlainduction Itl children. Can Anal!5!h Soc J 1983: 30: 286-289.11. Black GW, Sush GH. Morns P. Pa:.'diatrlc anaesthesia. BMJ 1985; 291: 542.12. Holt S. Paediatric anaesthesia. BMJ 1985; 291: 673.13. Richard C. Paediatric anaesthesia. BMJ 1985; 291: 672-673.14. Roberts WO. Paediatric anaestheSIa. BMJ 1985; 291: 5.13.15. Kilpatrick S. Paediatric anaesthesia. BMJ 1955; 291: 543.16. Henderson MA. Seines DB. Overton JH. Parental attitudes to presence atinduction of paediatric anaesthesia. Anaesrh Intensive Care 1993; 21: 320:-327.17. Bevan JC. Johnston C. Hillg MJ. Preoperalive parental anxiety predictsbehavioural and emotional responses to InductIon of anaestheSIa In chlldren. CanJ Anae$tIl199O; 31: 177-162.18. 6raude N. Staclley SA. Sumner E. Parents and p~iatnc anaesthesia: aprospective survey of parental arntuces to their presence at indUCtion. Ann RCoIl Svrg Engf 1990; 72: 4144.Accepted 13 Feb 1995.•ARTICLESThe efficacy of twobupivacaine hydrochlorideinjection productsF. O. Muller, J. P. Claasen, R. Schall,E. M. Mogilnicka, J. du T. Vas, G. Groenewoud,M. V. Middle, A. A. StultingObjective. The relative efficacy of two bupivacainehydrochloride injection products was investigated inpatients who were undergoing intra-ocular eye surgery.Design. Patients took part in this double-blind,randornised, parallel-group study and received eitherMacaine (Keatings) or Regibloc (Intramed), according tothe randornisation schedule.Setting. The study was carried out in the ophthalmologyoperating theatres of National and Pelonomi Hospitals,Bloemfontein, South AfricaPatients. Thirty male and 74 female patients whoneeded extra-capsular lens extraction plus intra-ocularlens implantation, extra-capsular lens extraction, ortrabeculectomy were selected for the study.Outcome measures. Akinesia was evaluated after 10,15 and 20 minutes. In the event of incomplete akinesiaafter 20 minutes, an additional injection was administered,and after 5 minutes another evaluation of akinesia wasdone. Anaesthesia was evaluated at the beginning ofsurgery.Results_ The proportions of patients who received noadditional anaesthesia were 57.7% for Macaine and 70.8%for Aegibloc (drtference 13.1 %, 95% confidence interval(Cl) -5.5 - 31.7%). The proportions of patients withadequate akinesia (possibly after additional anaesthesia)were 90.4% for Macaine and 89.6% for Regibloc(difference -0.8%, 95% Cl -12.6 - 11.0%).The proportions of patients experiencing no pain ordiscomfort at the beginning of surgery were 88.2% forMacaine and 87.5% for Aegibloc (drtference -0.7%, 95%CI-13.6 -12.1%).FARMOVS Research Centre for Clinical Pharmacology and DrugDevelopment and Department of Ophthalmology, University of theOrange Free State, BloemfonteinF. O. Muller. M_S CH a.J. P. Claasen. M B. CH.S.. M.MEO. (OPTrVL)R. Schall. DIPL MAlli.. PH.O.E. M. Mogilnicka. PH.O.J. du T. Vas. M.B. CH.S.. M.MED. (OPTHAL)G. Groenewaud. PH.OM. V. Middle. M.B CH..a.A. A. Stuffing. M.6. C.....S. M_Ml'".D. (()f'Tl-W..). F.RC.lQFTli..~ FC.S. {SAl. rAC.S.SAMJ rolumc' 86 So. 6 June 1996Conclusion. The study results indicate that Regibloc isat least as effective as, or superior to, Macaine inachieving adequate akinesia.S Afr Med J 1996; 86: 667-669.Bupivacaine hydrochloride is a long-acting local anaestheticof the amide type, with a duration of action of up to 10hours. Onset of action and depth of anaesthesia dependupon the concentration, dose, route of application, andwhether adrenaline is used. Bupivacaine hydrochloride isused mainly for infiltration and regional nerve blocks,particularly epidural block.' Mixtures of bupivacaine andhyaluronidase, with or without adrenaline, are used inperibulbar anaesthesia.2.JDifferences in the efficacy of two bupivacainehydrochloride injection products (Macaine; Keatings andRegibloc; lntramed) available in South Africa were reported,albeit anecdotally. This study was therefore performed tocompare the efficacy of Regibloc injection with respect tothe reference product, Macaine injection, in ocular surgery.MethodsStudy populationThirty male and 74 female patients who were undergoingintra-ocular eye surgery took part in this study. For biometricanalysis, the data from 100 patients were available. Thedemographic data are summarised in Table I. Before theoperation, the nature, purpose and risk of the procedureinvolved was explained to all patients. They signed aconsent form in the presence of a clinical investigator. Thestudy was approved by the ethics committee of theUniversity of the Orange Free State, Bloemfontein, SouthAfrica, and performed in conformance with Good ClinicalPractice guidelines.~.5Table l. Demographic dataMacaine Regibloc(52 patients) (48 patients)HospitalNational 28 23Pelonomi 24 25SexMale 15 14Female 37 34RaceWhite 26 21Black 26 26Coloured 1Age (yrs) 69 71(mean and range) (39 - 90) (45 - 94)Type of operationECLE + lOll 36 26ECLE 13 18Trab. 3 4EyeLeft 26 20Right 26 28ECU - IOU" eKtra-eapsular lel1S extraction plus intra-ocular lens implantation: ECLE'" extra--<:apsular lens extraetl<ln: Trab. " trabeculectomy.Study designThis was a double-blind, randomised, parallel-group study.Patients received an injection of 0.5% bupivacainehydrochloride, either Macaine or Regibloc according to therandomisation schedule.Study performanceThe study was carried out in the ophthalmology operatingtheatres of National and Pelonomi Hospitals, Bloemfontein.One of the following operations was carried out: extra-capsular lens extraction plus intra-ocular lens implantation,extra-capsular lens extraction, or trabeculectomy. Eachpatient received a peribulbar injection of a 10 mlbupivacaine hydrochloride solution, mixed with 150 units ofhyaluronidase (Kinetin; Schering), prepared by an assistantwithin 1 hour of use.""J Peribulbar anaesthesia was effectedwith 8 - 9 ml of the solution. The volume depended on theclinical impression of the orbital pressure. Equal volumes ofthe solution were injected at two different sites with a 22Gneedle inserted past the equator of the globe: just above theinferior orbital rim in the inferotemporal quadrant (inferior),just lateral to the supratrochlear notch (superior).After the block, the patient received digital massage of theeyelids for 2 minutes. Extra-ocular pressure was appliedwith a Honan balloon for 20 minutes. The akinesia wasevaluated by the surgeon 10, 15 and 20 minutes after theinjection. In the event of incomplete akinesia after 20minutes, an additional injection of 1 - 2 ml of the samesolution was administered either at the superior or theinferior position. The total volume administered did notexceed 10 ml. After 5 minutes, another evaluation ofakinesia was done. If akinesia had not occurred after anadditional injection was given, the block was considered tohave failed. The evaluation of anaesthesia was done at thebeginning of surgery.Efficacy variablesEvaluation of akinesia. The follOWing muscle movementswere recorded: medial rectus (MR), lateral rectus (LR),superior rectus (SR), inferior rectus (IR), eyelid.Full movement was recorded as 0, partial movement as 1and total paralysis as 2. The total score was recorded as thesum of the five individual scores, and graded as folJows: 2 8,9 and 10 - akinesia suitable for operation (adequateakinesia), except in cases where only one of the muscleswas responsible for a score of 8 (i.e. one muscle scored 0);5, 6 and 7 - partial akinesia that requires additionalanaesthetic; 4 and lower - akinesia not suitable foroperation.If additional local anaesthetic was needed, the position ofinjection (superior or inferior) was recorded, as well as thevolume of the solution injected.Evaluation of anaesthesia. The evaluation of anaesthesiaat the beginning of surgery was recorded as follows: pain :::::0; discomfort ::::: 1; no pain or discomfort ::::: 2.Biometric methodsThe two treatments were compared by calculating pointestimates and 95% confidence intervals (Cls) for theI/O/lime 86 ."'-0.6 fun" 1996 SAMJ•ARTICLESTable 11. Evaluation of akinesia. need for additional anaesthesia, and pain score (dose injection of solution containing 5 mg bupivacainehydrochloride per ml)Macaine Regibloc(reference) (test)No. % No. % Difference (%r 95% Cl (%),25/52 48.1 32/48 66.7 18.6 -0.4 - 37.630/52 57.7 33/48 68.8 11.1 -7.7 - 29.831/52 59.6 34/48 70.8 11.2 -7.3 - 29.730/52 57.7 34/48 70.8 13.1 -5.5 - 31.747/52 90.4 43/48 89.6 -0.8 -12.6 - 11.045/51 88.2 42/48 87.5 -0.7 -13.6 -12.1Adequate akinesia after 10 minAdequate akinesia after 15 minAdequate akinesia after 20 minNo additional anaesthesiaAdequate akinesia (pass. after add. anaesthesia);'No pain or discomfort at beginning of surgery• Point 2Stlmates fo( the ,est-reference" difference be,-ween treaunems.T 95% Cl for .he difference berw-eerl treatments.:I.: MissIng pam scores were replaced by a pam score of 0 (pam).differences between the treatments in the followingproportions: (I) the proportions of patients with adequateakinesia after 10, 15 and 20 minutes after injection,respectively; (h) the proportions of patients requiring noadditional anaesthesia; (iil) the proportions of patients withadequate akinesia, 5 minutes after additional anaesthesia;and (iv) the proportions of patients with no pain ordiscomfort at the beginning of the operation. The Gls werecalculated as described by Gardner and Altman.6ResultsThe point estimates and els for the true 'test-reference'differences in the proportions are given in Table 11.The proportions of patients who received no additionalanaesthesia were 57.7% for Macaine and 70.8% forRegibloc (difference 13.1%, 95% CI-5.5 - 31.7%). Theproportions of patients with adequate akinesia (possiblyafter additional anaesthesia) were 90.4% for Macaine and89.6% for Regibloc (difference -0.8%.95% CI-12.6-11.0%).In 10 cases of block failure, the patients were givenadditional anaesthetic and the planned operations weresuccessfully performed. The following were recorded: 4patients received an additional injection of Macaine, 5patients received an additional injection of Remicane (2%solution), and 1 patient, with a score of 8 but withinadequate anaesthesia, received local drops ofamethocaine during the operation, In all cases of blockfailure (Le. inadequate akinesia), anaesthesia was notevaluated and a score of 0 was used for statistical analysis.The proportions of patients experiencing no pain ordiscomfort at the beginning of surgery were 88.2% forMacaine and 87.5% for Regibloc (difference -0.7%. 95% Cl-13.6 - 12.1%).indicate that Regibloc is at least as effective as, or issuperior to, Macaine in achieving adequate akinesia. Afteradditional injections in cases of inadequate akinesia, bothproducts appear equally effective.The point estimates and Gls for the test-referencedifference in the proportions of patients with adequateakinesia (possibly after additional anaesthesia), and in theproportions of patients with no pain or discomfort at thebeginning of surgery, indicate that the two treatments wereequally effective with respect to those efficacy variables.Regibloc is therefore at least as effective as Macaine inachieving adequate anaesthesia for intra-ocular eye surgery.The authors thank Intramed, a division of South AfricanDruggists, for financial support, the nurses and surgicalassistants of National and Pelonomj Hospitals, Miss J. M.Erasmus and Professor H. G. Luus for assistance with thestatistical analysis, and Mrs L. van der Westhuizen forassistance in preparing the manuscript.REFERENCES1. Reynokis JEF. ed. MarondaJe: The EArt'il Pharmacopoe,a. 29m ed LondonPharmaceutical Press. 19a9. 1209-12122. Lewls P. Hamilton RC. Bram R. Loken RG. Maltby JR. Strunln L. Companson 01plam w,tn pH·adlustld buplvacame wltll hyaluronldaselor penoulbar block CanJ Anaesrh 1992; 39: 555-558.3. Morsman CO. Holden R. The eflects of adrenaline. hyaluronloase and age onplnbulbar anaesthesia. Eye 1992; 6: 290-292..: Commission of the European CommUnities. Investigation 01 bloavallab'hty andb,oequlvalence. In: The Rules Go~emmgMeclcmal ProduClS In rhe EuropeanCommuruty_ Vol 111_ Addendum No 2 GUld!!lmes on Ihl qualily. safery andefficacy of med,clnal products for human use Luxembourg- Office lor Offic'alPubhcauons of tile European Comm.tte<'S. 1992- 149,1685 Comm,sslon of tile European CommuOlues. Goocl Chntcal pracllCe for mals onmea,cmal prOdUCTS Itl the European Community In The Rules GO~fffWlgMra,c/ruJl PrOCUCIS In rne European COl""1munrry VOI Ill. Aadendum JUly 1990GUIdelines on Ihe Qualoty. safety and efficacy Of mra.cmal prOducts for humanuse Luxembourg Office for Off,clal PL.olicallons 01 Ine European Committees.1990: 57-98.G Gardner MJ. A1tman OG, eds. SUJflSIICS wHn Confldencl. London: Brlllsh MedicalJournal. 1989: 29-30,Accepted 1 Sep 1995.DiscussionThe point estimates and els for the 'test-reference'difference in the proportions of patients with adequateakinesia at 10, 15 and 20 minutes after the first injectionSAMJ \'olum.. 86 .\"0.6 fun.: 1996

The efficacy of two bupivacaine hydrochloride injection products

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The efficacy of two bupivacaine hydrochloride injection products

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