Feliks Hlumcher1, *Oleksandr Oliynyk2, Serhij Solyaryk3, Ihor Kolosovych1, Anna Slifirczyk2, Klaudiusz Nadolny4, 5, Jerzy Robert Ladny4
Application of intraperitoneal bupivacaine injection for pain relief after laparoscopic cholecystectomy
Zastosowanie dootrzewnowej iniekcji bupiwakainy do leczenia bólu po laparoskopowej cholecystektomii
1Bogomolets National Medical University, Kiev, Ukraine
2Pope John Paul II State School of Higher Education in Biala Podlaska, Poland
3Kiev City Clinical Hospital No 4, Kiev, Ukraine
4Department Emergency Medicine, Medical University of Bialystok, Poland
5University of Strategic Planning in Dabrowa Gornicza, Poland
Wstęp. Ostatnio dootrzewnowe wstrzyknięcie miejscowych leków przeciwbólowych praktykowane było jako element pooperacyjnego znieczulenia wielomodalnego w inwazyjnych ginekologicznych interwencjach chirurgicznych.
Cel pracy. Badanie skuteczności dootrzewnowej iniekcji bupiwakainy w celu łagodzenia bólu po cholecystektomii laparoskopowej.
Materiał i metody. Randomizowane badanie kliniczne z podwójnie ślepą próbą obejmowało 28 pacjentów w wieku od 32 do 60 lat (16 kobiet i 12 mężczyzn) poddanych cholecystektomii laparoskopowej. Pacjentów podzielono losowo na 2 grupy, w zależności od tego, czy bupiwakainę stosowano przez 24 godziny w kompleksowym znieczuleniu pooperacyjnym (0,125% roztwór dootrzewnowo w dawce 0,6 ml/kg (0,7 mg/kg substancji bupiwakainy), co 6 godzin). Stan pacjenta oceniono na wizualnej skali analogowej (VAS) 1, 4, 8, 12 i 24 godziny po operacji. Ponadto ustalono średnią liczbę fentanylu (mcg/kg) użytą do pojedynczej ulgi w bólu.
Wyniki. Wstrzyknięcie dootrzewnowej bupiwakainy po cholecystektomii laparoskopowej miało wyraźne działanie przeciwbólowe, objawiające się niezawodnie 1,47-1,77-krotnym spadkiem wskaźnika bólu w skali analogowej VAS i 1,55-krotnym zmniejszeniem dawki przeciwbólowej fentanylu.
Wnioski. Wydaje się właściwe stosowanie dootrzewnowej iniekcji bupiwakainy jako części kompleksowego znieczulenia we wczesnym okresie pooperacyjnym po cholecystektomii laparoskopowej.
Introduction. Lately, intraperitoneal injection of local analgesics has been practised as an element of postoperative multimodal anaesthesia in some minimally invasive gynaecologic surgical interventions.
Aim. To analyse efficacy of intraperitoneal bupivacaine injection for pain relief after laparoscopic cholecystectomy.
Material and methods. Randomized double-blind clinical examination included 28 patients, aged between 32 and 60 (16 women and 12 men) who had undergone laparoscopic cholecystectomy. Patients were randomly divided into 2 groups, depending on whether bupivacaine had been applied for 24 hours in complex early postoperative anaesthesia (0.125% solution intraperitoneally, in a dose of 0.6 ml/kg (0.7 mg/kg of bupivacaine substance), every 6 hours). Patients’ condition was assessed on a visual analogue scale (VAS) 1, 4, 8, 12, and 24 hours after surgery. In addition, average number of fentanyl (mcg/kg) that had been used for a single pain relief was established.
Results. Intraperitoneal bupivacaine injection after laparoscopic cholecystectomy had marked analgesic effect which revealed itself in reliable 1.47-1.77 times decrease in pain index on the VAS, and 1.55 times decrease in the analgesic dose of fentanyl.
Conclusions. It seems to be appropriate to use intraperitoneal bupivacaine injection as a part of comprehensive multimodal anaesthesia in early postoperative period after laparoscopic cholecystectomy.
Cholelithiasis is one of the most wide-spread human diseases, involving 10-15, 6-8, and 13-35% of European, Asian, and Latin American population, respectively. The lowest prevalence of cholelithiasis is reported in African natives – 1% (1). In Ukraine, prevalence of cholelithiasis is 10-25%, depending on the region (2). It is significant that the number of those suffering from calculous cholecystitis is increasing worldwide every year that is furthered by dietary habits, obesity or excessive losing flesh, diabetes mellitus, heritable propensity, sedentary lifestyle, etc.
Therapeutic means of cholelithiasis treatment are not always effective, thus making surgery required. Every year, a million and a half are done worldwide, the USA accounting for 600-700 thousand of them. Acute cholecystitis mostly afflicts able-bodied category of 41-60 years, though the number of older people is growing from year to year that reflects general demographic tendency (1).
Today, 90-95% of cholecystectomy operations are performed through laparoscopy (3). A number of challenges persist in the postoperative case management, in particular, treatment of postoperative pain syndrome (PPS) (4). Even with uncomplicated laparoscopic cholecystectomy, duration of the hospital stay is above all determined by PPS manifestations. Severe PPS in the first day after laparoscopic cholecystectomy develops in 14-41% of patients, being one of the reasons for prolonged disability. A lot of methods have been suggested to decrease PPS, including application of narcotic and non-narcotic analgesics, non-steroidal anti-inflammatory drugs, decompression during pneumoperitoneum surgery, decreasing the number of trocar holes (5).
Today, the strategy of multimodal anaesthesia that involves application of analgesic drugs with different modes of action, is used for PPS control. Lately, intraperitoneal injection and infiltration of trocar sites with local analgesics as an element of anaesthesia, has been used in minimally invasive interventions (3, 6). Though first used by E.M. Griffin as far back as 1951 (7), the method was then unduly abandoned for a few decades.
The objective of this research was to analyse analgesic efficacy of intraperitoneal bupivacaine injection for anaesthesia after laparoscopic cholecystectomy.
MATERIAL AND METHODS
Randomized double-blind clinical examination included 28 patients, aged between 32 and 60 (16 women and 12 men) who had undergone laparoscopic cholecystectomy. Patients were randomly divided into 2 groups, depending on whether bupivacaine had been applied for 24 hours in complex early postoperative anaesthesia (intraperitoneally, in a dose of 0.7 mg/kg, every 6 hours). Strict adherence to the ethical principles of Helsinki Declaration, GCP regulations, and current regulatory requirements was provided. The patients under examination were well informed about research materials and gave their voluntary consent to participate, the research protocol having been previously approved by the commission on bioethics of O.O. Bogomolets National Medical University. The study was undertaken on the basis of Kyiv City Clinical Hospital No 4. Prior to the surgical intervention, each patient was informed about the visual analogue scale of pain assessment (1).
Each laparoscopic cholecystectomy procedure was performed under general anaesthesia and artificial pulmonary ventilation with low-flow sevoflurane inhalation anaesthesia through semi-closed circuit in LeonPlus anaesthesia machine. Sodium thiopental (3.0 mg/kg) was used for induction, and atracurium (average dose 0.6 mg/kg) was applied as a myorelaxant. Fentanyl (0.0014 mcg/kg) was injected for anaesthesia. Volume of ventilation was set so that the pressure of carbon dioxide in the exhaled mixture was 30-40 mm Hg. During laparoscopy, the intracranial pressure in all patients was maintained at 10-12 mm Hg.
The patients were divided into two groups: No 1 (control) and No 2 (experimental). Criteria for the inclusion of patients in the study: age from 18 to 60 years, the presence of a planned laparoscopic cholecystectomy. Exclusion criteria for patients from the study: opiate abuse in history, the presence of chronic pain syndrome, hypersensitivity to pain in history. During the study, 45 patients were screened. According to the criteria, 10 patients were excluded, 7 patients did not give informed consent to participate in the study. In group 1, ketorolac tromethamine (0.2 mg/kg intramuscularly, every 6 hours) was used for anaesthesia. In case of complaints about postoperative pain, assessed at 7 and more points on the visual analogue scale, intramuscular injection of fentanyl in a dose of 0.003 mcg/kg was given. In group 2, aside from the elements of modal anaesthesia used in group 1, 0.125% bupivacaine solution in a dose of 0.6 ml/kg (0.7 mg/kg of bupivacaine substance) was being injected into drainage tubes for 24 hours after surgical procedure. Injections were repeated every 6 hours. Patients’ condition was assessed on the visual analogue scale 1, 4, 8, 12, and 24 hours after surgery. In addition, average number of fentanyl (mcg/kg) that had been used for a single pain relief was established.
Statistical processing included calculation of mean arithmetic values (M) and standard deviation (± SD). The data array was tested for normal distribution using the Shapiro-Wilk test. Source data having normal distribution, Student t-distribution was used to determine statistical significance of different mean values. The levels of statistical significance were calculated, the changes regarded as significant at p < 0.001. Microsoft Excel 2010 and Statsoft STATISTICA 10 programs were used for calculations.
Both groups showed no reliable difference in age, weight, and number of various medicines which had been used in surgical procedures (tab. 1).
Tab. 1. References of the patients in groups 1, 2
|Criteria||Group No 1 (n = 14)||Group No 2 (n = 14)|
|Age, years ||62.4 ± 8.2||65.6 ± 6.5|
|Duration of procedure, min.||55.6 ± 10.2||54.8 ± 11.6|
|Duration of anaesthesia, min.||64.8 ± 13.5||66.9 ± 12.4|
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