|Year : 2015 | Volume
| Issue : 2 | Page : 247-251
Intraperitoneal instillation of l-bupivacaine in laparoscopic pediatric procedures: a randomized-controlled study
Saad El Basha, Maha G Hanna, Sherif M Soaida, Hagar H Refaee
Department of Anesthesia, ICU, and Pain Management, Faculty of Medicine, Cairo University, Cairo, Egypt
|Date of Submission||24-Oct-2014|
|Date of Acceptance||22-Mar-2015|
|Date of Web Publication||8-May-2015|
Sherif M Soaida
Department of Anesthesia, Kasr Al Ainy Hospital, Cairo University, Kasr Al Ainy Street, Cairo 11562
Source of Support: None, Conflict of Interest: None
Clinical trial registration NCT02037711
Background and aim
Pain following laparoscopy is mostly because of irritation of the diaphragm and stretching of the peritoneum associated with carbon dioxide insufflation. In this study, we evaluate the effectiveness of periportal xylocaine infiltration and intraperitoneal instillation of l-bupivacaine at the beginning of laparoscopy in pediatrics in reducing postoperative pain, delaying the onset and reducing the total dose of rescue analgesia, and improving perioperative hemodynamics.
Patients and methods
After receiving ethical committee approval in Kasr Al Ainy University Hospital and parents' consent, 40 ASA I and II children were allocated randomly to two groups. In group I, l-bupivacaine 0.5% instilled into the peritoneal cavity immediately after gas insufflation at a dose 2 mg/kg. In group II, normal saline was instilled instead of l-bupivacaine. All patients were subjected to preincisional periportal lidocaine 1% infiltration. Heart rate (HR) and blood pressure were recorded at 5 min intervals starting from the preoperative period until 6 h postoperatively. The Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) score was used, and the onset and dose of pethidine were recorded.
HR was lower in group I and HR4 was significantly lower (P < 0.001). The mean arterial blood pressure (MAP) was also lower in group I. It was significantly lower in MAP3 and MAP4 (P = 0.049 and 0.004, respectively). The median pain score was significantly lower in group I (P = 0.001). Onset of rescue analgesia demand was longer in group I and the total dose of pethidine was significantly lower in group I (P < 0.001).
Periportal lidocaine infiltration and intraperitoneal l-bupivacaine instillation in pediatric laparoscopy, after pneumoperitoneum, reduced postoperative pain and improved perioperative hemodynamics.
Keywords: anesthesia, instillation, laparoscopy, l-bupivacaine, pediatrics
|How to cite this article:|
El Basha S, Hanna MG, Soaida SM, Refaee HH. Intraperitoneal instillation of l-bupivacaine in laparoscopic pediatric procedures: a randomized-controlled study. Ain-Shams J Anaesthesiol 2015;8:247-51
|How to cite this URL:|
El Basha S, Hanna MG, Soaida SM, Refaee HH. Intraperitoneal instillation of l-bupivacaine in laparoscopic pediatric procedures: a randomized-controlled study. Ain-Shams J Anaesthesiol [serial online] 2015 [cited 2021 Apr 14];8:247-51. Available from: http://www.asja.eg.net/text.asp?2015/8/2/247/156702
| Introduction|| |
Pain following laparoscopy is less intense than after laparotomy. Nevertheless, laparoscopy is not pain free and control of postlaparoscopy pain remains a major concern , . The exact cause of such pain remains uncertain, and yet, diaphragmatic irritation and peritoneal stretching associated with gas insufflation may be responsible for shoulder and diffuse abdominal pain  .
It was suggested that an intraperitoneal application of a local anesthetic at the beginning of surgery functioned as preemptive analgesia depressing central neural sensitization before the nociceptive stimulus triggers pain pathways  .
Instillation/nebulization techniques were used for intraperitoneal applications of local anesthetics in laparoscopic surgery, but these techniques are not used widely in pediatrics.
| Aim|| |
The aim of this study was to evaluate the effectiveness of intraperitoneal instillation of l-bupivacaine at the beginning of laparoscopic surgeries in pediatrics together with periportal infiltration, in reducing postoperative pain, delaying the onset and decreasing the total dose of rescue analgesia, and improving intraoperative and postoperative hemodynamics.
| Patients and methods|| |
This randomized-controlled study is a single institutional, prospective, clinical trial that was conducted in Abu El-Reesh Pediatric Hospital, Faculty of Medicine, Cairo University, between May 2013 and November 2013. On the basis of the Helsinki Declaration, following the guidelines in this investigation, after approval of the ethical committee in Kasr Al Ainy University Hospital, and registration at http://www.clinicaltrials.gov, with the number NCT02037711, 40 pediatric patients, ASA I and II, of both sexes, weighing more than 4 kg and candidates for laparoscopic surgery, were included in the study. A written informed consent was obtained from the parents or the legal guardians. Patients were allocated randomly to one of two groups using Excel 2010 (Microsoft Corp., Redmond, Washington, USA). Groups were distributed by concealed envelopes. Group I (l-bupivacaine group; n = 20): l-bupivacaine 0.5% was instilled into the peritoneal cavity immediately after insufflation of CO 2 at the beginning of surgery at a dose of 2 mg/kg. Group II (control group; n = 20): laparoscopy was performed with instillation of normal saline instead of l-bupivacaine. Both groups were subjected to preincisional periportal infiltration with xylocaine 1%.
Patients were excluded from the study if they were allergic to l-bupivacaine or any local anesthetic, were receiving chronic pain treatment or antiepileptic therapy, or had severe hepatic or renal impairment, cardiopulmonary problems, cognitive impairment, or communication problems.
On the day of surgery children were visited by the anesthesiologist preoperatively for history taking and physical examination. kids were provided by the psychological support needed to reduce their anxiety through making them familiar with the procedure and doctors. Patients were allowed to fast according to the ASA guidelines.
Sedation was induced by the administration of midazolam at a dose of 0.2 mg/kg intramuscularly ~20 min before induction of anesthesia. On arrival to the operating room, all patients were connected to ECG, noninvasive blood pressure, and pulse oximetry for routine basic monitoring, and then inhalational induction was initiated using sevoflurane 2-6%. An intravenous cannula was inserted and atracurium besylate at a dose of 0.5 mg/kg was administered and endotracheal intubation was performed after 3-5 min. Tube size was calculated according to the formula: age/4+4. Anesthesia was maintained with 100% oxygen, isoflurane 1.5% with total fresh gas flow 3 l/min controlled by mechanical ventilation, tidal volume 5-10 ml/kg, and respiratory rate adjusted according to the end tidal CO 2 (maintaining CO 2 in the normal range of 35-45 mmHg). Atracurium besylate 0.1 mg/kg intravenously was repeated every 20-30 min to ensure proper muscle relaxation.
Patients in both groups received fentanyl 1-2 μg/kg on induction, and by the end of surgery, intravenous paracetamol (Perfalgan, Bristol-Myers Squibb Pharmaceuticals Ltd, New York City, NY, USA) 7.5 mg/kg (if the patient was < 1 year of age) or 15 mg/kg (if the patient was > 1 year of age)  .
In both study groups, laparoscopic surgery was performed according to the standard surgical protocol. Local infiltration of port sites was performed by xylocaine 1% at a maximum dose of 3 mg/kg, a classical surgical technique that consists of placement of 5 and 3 mm ports at different sites of the abdominal wall according to the type of surgery. Pneumoperitoneum was achieved using nonhumidified and nonheated CO 2 , with the intra-abdominal pressure maintained around 10 mmHg.
In group I (l-bupivacaine group), l-bupivacaine 0.5% was instilled during insufflations of CO 2 at the beginning of surgery at a dose of 2 mg/kg. However, in group II (control group), laparoscopic surgery was performed with instillation of normal saline instead of l-bupivacaine. Instillation was performed toward the under surface of the diaphragm in both groups, through the umbilical port, irrespective of the type of surgery. The patients were shifted to the Trendelenburg position for 10 min before returning the operating table to the zero position and allowing the surgeons to proceed with their procedure. Local infiltration of lidocaine 1% was performed before any incision was carried out in both groups.
At the end of the operation, CO 2 was cleared completely from the peritoneal cavity by manual compression of the abdomen. Reversal of the muscle relaxant was carried out using prostigmine at a dose of 0.05-0.07 mg/kg and atropine at a dose of 0.02 mg/kg. The patients were then transferred to the recovery room, where monitoring of oxygen saturation, heart rate (HR), noninvasive arterial blood pressure, and pain scoring was carried out at 10-min intervals.
HR was monitored and recorded at 5-min intervals. The mean HR recorded in the preoperative period until the time of induction was represented by HR1, from the time of induction until the instillation of local anesthetic was represented by HR2, from the time of instillation until the end of surgery was represented by HR3, and that recorded postoperatively, in the recovery period, was represented by HR4.
Blood pressure was also monitored and recorded at 5-min intervals and the mean arterial blood pressure (MAP) was calculated. The mean MAP calculated recorded in the preoperative period until the time of induction was represented by MAP1, from the time of induction until the instillation of local anesthetic was represented by MAP2, from the time of instillation until the end of surgery was represented by MAP3, and that recorded postoperatively, in the recovery period, was represented by MAP4.
Assessment of pain was performed after extubation and recovery at 0, 1, 2, and 6 h postoperatively using the Children's Hospital of Eastern Ontario Pain Scale (CHEOPS) scoring, which is a behavioral observation scale for the evaluation of postoperative pain in young children. The scale comprises six types of pain behavior: cry, facial, verbal, torso, touch, and legs. Each type has 3-4 grades. The minimal possible score is 4 points (no pain) and the maximum is 13 points (most awful pain)  . The onset and dose of rescue analgesia was recorded. Rescue analgesia was administered in the form of pethidine 1 mg/kg intravenously when the pain score was equal to or more than 10.
Statistical analysis was carried out using statistical package for the social sciences (SPSS, version 20; IBM Corp., Armonk, North Castle, NY, USA). Continuous data were reported as mean ± SD. Categorical data were summarized as frequencies and percentages. Repeated-measures analysis of variance was used for intergroup comparisons of continuous data. Pairwise comparisons were performed with Bonferroni adjustment if analysis of variance was significant. Independent-samples Student's t-test was used to compare continuous variables between the two groups studied. The χ2 -test of independence was used to show the relationships between binary or categorical variables between the two studied groups. In all tests, results were considered statistically significant if the P-value was equal or less than 0.05.
Sample size calculation
Sample size was calculated using G*Power3 (Heinrish Heine University, Dusseldorf, Germany). Sample size measurement was calculated on the basis of a 30% reduction in the total requirements of postoperative analgesia (pethidine) over the first 6 h postoperatively between the two study groups. The calculated sample size per group was 18 patients. Considering the dropout rate, 20 patients were included in each study group. Therefore, a total of 40 patients were included in the entire study. This measurement was necessary to achieve a power of 80%, assuming an α level of 0.05.
| Results|| |
Laparoscopic surgeries were performed for 40 children (35 male and five female) from May 2013 to November 2013. Patients were classified randomly into two equal groups; each group included 20 patients. All cases were included for statistical analysis.
In terms of age, sex, weight, and type of operation, there were no statistically significant differences between the two study groups ([Table 1] and [Table 2]).
There was a significant decrease in the HR in the l-bupivacaine group, as in the l-bupivacaine group, the HR decreased about 5.6% from HR1-HR2 and about 13.9% from HR1-HR3 and from HR1-HR4, the HRs decreased about 19.2%.
However, in the control group, the HR decreased about 1.3% from HR1-HR2 and about 3% from HR1-HR3 and decreased only 3.8% from HR1-HR4.
There was a significant difference between both groups in the postoperative period, where HR4 in the l-bupivacaine group was lower than that in the control group (P < 0.001) ([Table 3]).
There was a statistical significance between blood pressure in both study groups only in MAP3 and MAP4, but blood pressure decreased significantly in the l-bupivacaine group as the blood pressure decreased about 4.6% from MAP1-MAP2, about 9.6% from MAP1-MAP3, and about 11.8% from MAP1-MAP4.
Although there was a difference between the blood pressure measurements in the control group, these were less than that in the l-bupivacaine group as the blood pressure decreased about 4.2% from MAP1-MAP2, about 5.9% from MAP1-MAP3, and decreased only 5.7% from MAP1-MAP4 ([Table 4]).
|Table 4 Difference between mean arterial blood pressures between both groups|
Click here to view
There was a significant difference in pain scoring between both study groups as pain scoring was obviously less in the l-bupivacaine group (median 6, range 5-10) than in the control group (median 10, range 9-11) (P = 0.001).
In terms of the onset of rescue analgesia in the l-bupivacaine group, the onset of need for rescue analgesia was within 1-2 h postoperatively, which was much longer than that in the control group, where the rescue analgesia was needed within 20-30 min ([Table 5]).
Over the first 6 postoperative hours, patients in the l-bupivacaine group received a total dose of pethidine of 16.55 ± 6.091, whereas those in the control group received a total dose of 26.1 ± 10.804 (P < 0.001). No cases of local anesthetic toxicity were reported during our study.
| Discussion|| |
The most predominant complaint following laparoscopic procedures, in the early postoperative period, is pain. This pain might be because of chemical irritation of the peritoneum, distension of the abdomen, soft tissue injury, or incisional trauma at the trocar entry sites , . In an attempt to decrease the severity of pain following laparoscopic procedures, many techniques have been adopted with adult patients such as using low inflation pressure, local anesthetic infiltration of port sites, intraperitoneal instillation, or nebulization of local anesthetic , . Yet, very few studies have been carried out targeting the pediatric population subjected to such types of surgeries.
l-bupivacaine, the S (-) isomer of racemate bupivacaine, is a long-acting amide-type local anesthetic; it has a nerve-blocking potency comparable with that of bupivacaine and the R (+) enantiomer of bupivacaine (dexbupivacaine)  . Although l-bupivacaine has comparable effectiveness to bupivacaine as a local anesthetic, it is reliably less toxic. It also acts for a longer duration mostly because of its vasoconstrictive action at lower doses  . Therefore, it was chosen for use in our study in the pediatric population.
In our study, we infiltrated trocar sites before skin incision by lidocaine 1%, and instilled l-bupivacaine 0.5% at a dose 2 mg/kg intraperitoneally immediately after pneumoperitoneum in pediatric patients undergoing laparoscopic surgeries and we found that instillation exerted beneficial effects on intraoperative and postoperative hemodynamics, postoperative pain relief especially in the early postoperative period during 0, 1, and 2 h postoperatively, and less demand for pethidine postoperatively. No cases of local anesthetic toxicity were reported during our study.
Di Pace et al.  carried out one of the very few studies involving children. They used local infiltration of port sites with 10 ml of ropivacaine and intraperitoneal instillation of 10 ml of ropivacaine at the end of surgery compared with only periportal infiltration with 10 ml ropivacaine. The grade of postoperative abdominal parietal pain, visceral pain, and shoulder pain was evaluated using a Wong-Baker pain scale and a visual analog scale at 3, 6 12, and 24 h postoperatively. They also assessed rescue analgesia, duration of hospitalization, and time of return to regular activities. They detected that the mean severity of abdominal visceral pain was significantly lower and rescue analgesia was significantly decreased in the group with intraperitoneal instillation of ropivacaine compared with the other groups. Their results were in line with ours in postoperative pain reduction, especially in the early postoperative periods, and in the reduction of the total dose of rescue analgesia. However, their study differed from ours in the use of ropivacaine; instillation was at the end of surgery instead of the beginning, as in our study, and they also used a different scoring system. Yet, this scoring system was not expected to affect the results.
Studies that were mostly focused on an adult population included the use of l-bupivacaine at different concentrations ,, or ropivacaine , . Some of the results of the studies were in agreement with ours, showing a decrease in postoperative pain and a delay in the onset of request for rescue analgesia ,,, . Hilvering et al.  reported that there was no significant decrease in postoperative pain following the instillation of l-bupivacaine. This is most probably because of the use of a low concentration of l-bupivacaine (0.125%). Other studies compared the use of local anesthetic instillation versus nebulization  . They found no significant difference between both groups in respect to pain scores, morphine consumption, and hospital stay. However, there was a significant reduction in the incidence of shoulder pain and time before unaided walking in the nebulization group. Yet, this was associated with a higher incidence of postoperative vomiting.
Although cholecystitis is rare in the pediatric population, out of the 40 patients included in our study, seven (17.5%) had cholecystitis and were candidates for laparoscopic cholecystectomy. This is explained by the fact that our children's hospital is a tertiary center that receives referral of such cases from all over the country. Also, such high percentage of cases with calcular cholecystitis is supported by the study carried out by Friesen and Roberts  , who reviewed 693 cases of pediatric cholelithiasis; 10% of gallstones were found in children younger than 6 months old and 21% were found in children between 6 months and 10 years old.
A limitation of our study is that we did not have a nebulizer device to compare between both techniques of intraperitoneal application of local anesthetic. Inevitably, all patients received neuromuscular blocking drug reversal including atropine, which might have affected hemodynamics.
Further studies are needed to compare different types of local anesthetics - that is, l-bupivacaine and ropivacaine. Also, different techniques should be compared - for example, nebulization and instillation.
| Conclusion|| |
Periportal infiltration and intraperitoneal instillation of l-bupivacaine in laparoscopic pediatric surgeries, after pneumoperitoneum, is a safe and effective technique that improves perioperative hemodynamics, reduces postoperative pain, and delays the onset of rescue analgesia.
| Acknowledgements|| |
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3], [Table 4], [Table 5]