| Abstract | Akutna postoperativna bol je u svakodnevnoj praksi i dalje u oko polovice kirurških bolesnika neadekvatno liječena. Uz standardizirani koncept multimodalne analgezije sve više se dolazi do otkrića novih analgetika i analgetskih adjuvantnih sredstava u liječenju akutne postoperativne boli. Svrha ovog istraživanja bila je istražiti učinak jednokratne preoperativne doze pregabalina od 150 mg u sprječavanju akutne postoperativne boli nakon oralnokirurških zahvata i kvantificirati potrebu za dodatnim postoperativnim analgetikom.
Proveli smo prospektivno, randomizirano, dvostruko-slijepo, placebo kontrolirano istraživanje. U placebo skupini bilo je 36 pacijenata, dok je u skupini koja je primila jednokratnu dozu pregabalina od 150 mg uključeno 35 pacijenta. Svi su pacijenti bili u dobnoj skupini od 18 do 60 godina starosti te pripadali skupini ASA I ili ASA II. Oralnokirurški zahvati izvršeni su u općoj endotrahealnoj anesteziji po standardiziranom anesteziološkom postupku. Intenzitet postoperativne boli mjerio se upotrebom vizualne analogne skale (VAS) u vremenskim razmacima 2, 6, 12 i 24 sata nakon zahvata. Također se evidentirala potreba za dodatnim postoperativnim analgetikom, brojem i vremenom uzimanja istoga. Statistička analiza učinjena je Hi-kvadrat testom i Mann-Whitney U testom te rezultati prikazani tablično i grafički.
Utvrđeno je da je medijan na vizualno analognoj skali (VAS) u placebo skupini iznosio 3,50 dva sata, odnosno 0,00 šest sati postoperativno. U pregabalinskoj skupini te su vrijednosti bile 1,00 dva i šest sati nakon zahvata što je statistički značajna razlika u odnosu na placebo skupinu. Također je ustanovljeno da je 77,8 % bolesnika u placebo skupini zatražilo najmanje jedanput postoperativni analgetik dok je u pregabalinskoj skupini taj iznos bio 54,3 %. U placebo skupini primijećeno je dvostruko više nuspojava, od čega su najčešće bile vrtoglavica i pospanost.
Istraživanje je pokazalo da je 150 mg preoperativnog pregabalina učinkovito u sprječavanju akutne postoperativne boli nakon oralnokirurških zahvata te da je kod bolesnika koji su primili aktivnu supstancu smanjena potreba za uzimanjem dodatnog postoperativnog analgetika. Također se pokazalo je upola manje nuspojava primijećeno kod pacijenata koji su primili pregabalin. S obzirom na to da statistička razlika rezultata između dvije skupine prestaje 6 sati nakon zahvata valjalo bi razmotriti novo istraživanje o učinkovitosti i sigurnosti veće doze pregabalina. |
| Abstract (english) | Introduction: In an everyday practice, acute postoperative pain remains inadequately treated in about 50% of oral surgery patients. Despite the implementation of multimodal analgesic concept about 25 years ago, there are still new analgesics and analgesic adjuvants that may show more promising results in the prevention and attenuation of acute postoperative pain. Pregabalin was introduced in 2004 as a successor of gabapentin. It has been proven to have anxiolytic, antiepileptic and analgesic properties. Moreover, it has been shown that pregabalin reduces acute postoperative pain in different surgical models as well as the need for rescue postoperative analgesics. There are still no conclusions or guidelines about the initial and postoperative dosing regimen for pregabalin in the perioperative period.
Aims of the research: We attempted to prove that pregabalin is able to prevent, or at least minimize, the acute postoperative pain after oral surgery treatment. Also, we believe that it reduces the need for a rescue postoperative analgesic. Furthermore, we aimed to investigate whether there would be a reduction in frequency of postoperative side effects.
Patients and methods: A prospective, randomized, double-blinded, placebo-controlled study was designed. One group of 35 patients was given a single preoperative 150mg dose of pregabalin one hour before oral surgery treatment. The other group consisted of 36 patients that were given a placebo. All patients denominated as ASA (American Society of Anesthesiologists) I or ASA II were 18 to 60 years old. The oral surgery treatment was performed under general anaesthesia standardized protocol. The intensity of postoperative pain was measured by the visual analogue scale (VAS) 2, 6, 12 and 24 hours after surgery. When there was a need for rescue postoperative analgesic, number and time of the given analgesic was registered. The statistical analysis was done using the Hi-square and Mann-Whitney U tests and the data were shown in tables and graphically.
Results: Significant differences in VAS values were observed at the first reading, i.e. 2 hours postoperatively. The median in the placebo group was 3.5 (IQR (Interquartile Range): 1.25-5.00), whereas 1.00 in the placebo group (IQR: 0.00-3.00), P=0.005. The number of rescue
analgesics (when observed quantitatively) and the time when a postoperative analgesic was necessary also showed significant differences. In the investigated group, patients called for the rescue analgesic significantly later (median 3.00 (IQR: 0.50-9.00) than in the control group (median 1.00 (0.50-2.00), P=0.019). Despite the identical median values, when observing the number of postoperatively taken analgesics, it was shown that the interquartile range (IQR) was greater in the control group. This indicates that the patients in the control group requested more rescue analgesics (P=0.029). The incidence of side effects was 5.6 % and 2.9 % in the control and investigated group respectively. The most common side effect was dizziness.
Conclusion: This study confirmed the hypothesis that pregabalin would, in the aforementioned dosage, reduce acute postoperative pain, with a statistically significant difference, compared to placebo in the early postoperative period. Furthermore, the same dose of pregabalin decreased the patients’ need for additional postoperative analgesic. In this dosage, pregabalin seems to be a safe treatment option, since only one side effect was observed in the trial. |
