TEL:010-88798994(Marketing)、88799826/9829(Switchboard)      简体中文 | English
Clinical report
HOME > News> Clinical report

KSH medical continuous injector for postoperative analgesia

  
Department of Anesthesiology, West China Hospital, Sichuan University    Yin Yan Liu Bin Hong Ying Yang Bangxiang In postoperative analgesia, patient-controlled analgesia (PCA) technology is timely, quick and convenient, follows individual differences, maintains a relatively stable minimum effective analgesic concentration (MEAC), good analgesic effect, and postoperative The advantages of fewer complications, high safety factor, and low incidence of side effects will gradually replace the traditional intermittent intramuscular injection [1,2,3]. "According to the route of administration, PCA is divided into epidural administration (PCEA), intravenous administration (PCIA), and subcutaneous administration (PCSA). The basic modes of administration include continuous infusion, patient-controlled administration, and patient-controlled administration based on continuous background infusion.    There are many types of PCA pumps [4]. In recent years, we have mainly used Australian Go Medical PCA pumps and American Microject electronic pumps. Practice has proved that analgesic pumps can provide better analgesic effects, reduce patient anxiety, and improve patient satisfaction. However, as a first-line analgesic, the potential life-threatening respiratory depression of opioid analgesics cannot be ignored, and it is the biggest hidden danger of PCA application.    In this study, domestically made KSH pump was used to inject tramadol + cosifane subcutaneously/venously to evaluate the postoperative analgesic effect, side effects and performance of KSH pump.    materials and methods Participants 62 patients with general surgery, urology, and general breast, aged 18-83 years, male:female = 36:24, ASA I~II grade, all underwent intravenous inhalation combined general anesthesia, and were randomly divided into intravenous administration (PCIA) group (30 Example) and subcutaneous administration (PCSA) group (32 cases). Exclude severe damage to liver and kidney function, digestive ulcer bleeding, coagulopathy, and non-steroidal anti-inflammatory drug allergy.    Method PCA formula: 800mg of tramadol + 32mg of cosaifen diluted with 0.9% saline to 100ml (tramadol concentration 8mg/ml, cosaifen concentration 0.32mg/ml). The analgesia pump uses the domestic KSH medical continuous infusion device. In the PCIA group, the intravenous infusion was started at the end of the operation, and the PCSA group was infused subcutaneously before the suture at the end of the operation, followed by a special person. Index 12, 24, 48h pain VAS score (0 is no pain, 10 is severe pain), sedation VAS score (0 is awake, 10 is lethargy), comfort VAS score (0 is comfortable , 10 points for very discomfort), anal exhaust time, side effects, dosage, time with pump.    Statistical analysis The count data are expressed as mean±standard deviation, the comparison between groups is by t test, and the count data is by x2 test. P<0.05 is statistically significant.    Experimental equipment KSH medical continuous injector provided by Beijing Kelian Shenghua Company, with a capacity of 100 ml and a flow rate of 2 ml/hour.   Result   Patient's general condition (table 1) and the average value of postoperative indexes (table 2)   Table 1 General conditions of patients Group gender (men and women) age (year old) Body mass index (kg/m2) Operation time (h) PCIAGroup 19/11 53.7±13.6 24.7±1.6 3.05±0.23 PCSAGroup 17/15 53.7±15.5 25.1±1.3 3.32±0.31     Comparison between the two groups P>0.05    There were no significant differences in gender, age, body mass index, and operation time between the two groups.    Table 2 The average value of various indexes after 60 patients Pain VAS score 12h after operation 2.97±0.97 24h after operation 2.5±0.66 48h after operation 2.02±0.87 Sedation VAS score 12h after operation 2.86±0.8 24h after operation 2.44±0.7 48h after operation 2.06±0.84 Moderate VAS score 12h after operation 2.73±0.71 12h after operation 2.44±0.7 48h after operation 2.0±0.85 Dosage (ml) 76.75±19.8 With pump time (h) 71.34±27.91 Anal exhaust time (h) 62.17±12.92       There were no significant differences in pain scores, sedation scores, and comfort scores between the two groups at 12h and 24h after surgery. At 48h after surgery, the pain scores in the PCSA group were significantly lower than those in the PCIA group (Table 3).   Table 3 Comparison of postoperative pain score, sedation score, comfort score and anal exhaust time between the two groups   pain VAS score Calm VAS score Comfortabl

  Department of Anesthesiology, West China Hospital, Sichuan University

   Yin Yan Liu Bin Hong Ying Yang Bangxiang In postoperative analgesia, patient-controlled analgesia (PCA) technology is timely, quick and convenient, follows individual differences, maintains a relatively stable minimum effective analgesic concentration (MEAC), good analgesic effect, and postoperative The advantages of fewer complications, high safety factor, and low incidence of side effects will gradually replace the traditional intermittent intramuscular injection [1,2,3]. "According to the route of administration, PCA is divided into epidural administration (PCEA), intravenous administration (PCIA), and subcutaneous administration (PCSA). The basic modes of administration include continuous infusion, patient-controlled administration, and patient-controlled administration based on continuous background infusion.

   There are many types of PCA pumps [4]. In recent years, we have mainly used Australian Go Medical PCA pumps and American Microject electronic pumps. Practice has proved that analgesic pumps can provide better analgesic effects, reduce patient anxiety, and improve patient satisfaction. However, as a first-line analgesic, the potential life-threatening respiratory depression of opioid analgesics cannot be ignored, and it is the biggest hidden danger of PCA application.    In this study, domestically made KSH pump was used to inject tramadol + cosifane subcutaneously/venously to evaluate the postoperative analgesic effect, side effects and performance of KSH pump.

   materials and methods Participants 62 patients with general surgery, urology, and general breast, aged 18-83 years, male:female = 36:24, ASA I~II grade, all underwent intravenous inhalation combined general anesthesia, and were randomly divided into intravenous administration (PCIA) group (30 Example) and subcutaneous administration (PCSA) group (32 cases). Exclude severe damage to liver and kidney function, digestive ulcer bleeding, coagulopathy, and non-steroidal anti-inflammatory drug allergy.

   Method PCA formula: 800mg of tramadol + 32mg of cosaifen diluted with 0.9% saline to 100ml (tramadol concentration 8mg/ml, cosaifen concentration 0.32mg/ml). The analgesia pump uses the domestic KSH medical continuous infusion device. In the PCIA group, the intravenous infusion was started at the end of the operation, and the PCSA group was infused subcutaneously before the suture at the end of the operation, followed by a special person. Index 12, 24, 48h pain VAS score (0 is no pain, 10 is severe pain), sedation VAS score (0 is awake, 10 is lethargy), comfort VAS score (0 is comfortable , 10 points for very discomfort), anal exhaust time, side effects, dosage, time with pump.

   Statistical analysis The count data are expressed as mean±standard deviation, the comparison between groups is by t test, and the count data is by x2 test. P<0.05 is statistically significant.

   Experimental equipment KSH medical continuous injector provided by Beijing Kelian Shenghua Company, with a capacity of 100 ml and a flow rate of 2 ml/hour.

  Result

  Patient's general condition (table 1) and the average value of postoperative indexes (table 2)

  Table 1 General conditions of patients

Groupgender (men and women)age (year old)Body mass index (kg/m2)Operation time (h)

PCIAGroup

19/11

53.7±13.6

24.7±1.6

3.05±0.23

PCSAGroup

17/15

53.7±15.5

25.1±1.3

3.32±0.31

 

  Comparison between the two groups P>0.05   

There were no significant differences in gender, age, body mass index, and operation time between the two groups.    Table 2

The average value of various indexes after 60 patients

Pain VAS score12h after operation

2.97±0.97

24h after operation

2.5±0.66

48h after operation

2.02±0.87

Sedation VAS score12h after operation

2.86±0.8

24h after operation

2.44±0.7

48h after operation

2.06±0.84

Moderate VAS score12h after operation

2.73±0.71

12h after operation

2.44±0.7

48h after operation

2.0±0.85

Dosage (ml)

76.75±19.8

With pump time (h)

71.34±27.91

Anal exhaust time (h)

62.17±12.92

 

 

  There were no significant differences in pain scores, sedation scores, and comfort scores between the two groups at 12h and 24h after surgery. At 48h after surgery, the pain scores in the PCSA group were significantly lower than those in the PCIA group (Table 3).

  Table 3 Comparison of postoperative pain score, sedation score, comfort score and anal exhaust time between the two groups


pain

VAS score

Calm

VAS score

Comfortable

VAS score

Anal

exhaust (Time (h)

PCIA group12h after operation24h after operation48h after operation12h after operation24h after operation48h after operation12h after operation24h after operation48h after operation

3.06

±

1.1

2.56

±

0.8

2.27

±

0.8

2.73

±

0.8

2.5

±

0.8

2.27

±

1.1

2.67

±

0.5

2.5

±

0.8

2.23

±

1.1

62.4±15.0

PCSAgroup

2.75

±

0.8

2.42

±

0.6

1.77

±

0.8*

2.78

±

0.8

2.39

±

0.6

1.8

±

0.8

2.75

±

0.8

2.39

±

0.6

1.77

±

0.8

62.7±13.9

 

  *P<0.05

  There was no significant difference in the amount of medication between the two groups, and the PCSA group had a significantly lower pump time than the PCIA group (Table 4).   

        Table 4 Comparison of dosage and pumping time between the two groups


Dosage (ml)With pump time (h)

PCIAgroup

77.17±19.2
 

63.38±20.9

PCSAgroup

76.33±17.5

76.74±28.1*

 

  *P<0.05

  discuss Opioid analgesics have always dominated the field of postoperative pain treatment due to their powerful analgesic effects, but there are many side effects, including respiratory depression, nausea and vomiting, urinary retention, skin itching, and addiction, among which delayed respiratory depression is difficult Prevention and prediction increase the risk factor of clinical application. How to achieve the purpose of effective postoperative analgesia and ensure the safety of patients' lives is the direction we strive to explore.

   Tramadol (Tramal) is a new type of weak opioid central analgesic synthesized in recent years. Suitable for moderate to severe pain. The analgesic mechanism is mainly to inhibit the reuptake of norepinephrine at neuronal synapses and increase the concentration of serotonin outside of neurons, thereby affecting pain transmission; in addition, tramadol has a greater effect on opioid mu, κ and δ receptors. Weak affinity. The analgesic effect can be maintained for 4 to 6 hours. No respiratory depression, low addiction and dependence, and low incidence of adverse reactions (such as nausea and vomiting).

   Kesaifeng, the main ingredient of Lornoxicam (LornoXicam), is a new type of non-steroidal anti-inflammatory and analgesic. The drug is versatile. In addition to treating various osteoarthritis, it is also suitable for postoperative pain[5,6], low back pain[7,8], cancer pain[9,10] and various chronic pain pains [11,12]. It has been proven that it can replace high-dose non-steroidal anti-inflammatory drugs and medium-dose opioids in terms of analgesia. Its mechanism of action includes: inhibiting the synthesis and release of pain mediator prostaglandins by inhibiting the activity of cyclooxygenase (COX); activating the opioid neuropeptide system to exert central analgesic effects. As part of balanced analgesia, the dosage of opioids can be reduced, thereby reducing the latter's adverse reactions, such as respiratory depression, nausea and vomiting, lethargy, and decreased bowel movements. Lornoxicam is relatively well tolerated, and its elimination half-life is short, so side effects are small, mainly for mild gastrointestinal symptoms [13]. Therefore, lornoxicam is an attractive analgesic drug that can replace morphine in the treatment of moderate to severe postoperative pain [14].

   This study uses the combined application of tramadol and cosaifeng to exert different analgesic effects from the central and peripheral mechanisms, and have a synergistic effect on the drug effect, thereby producing good analgesic effects. Compared with intermittent administration, continuous infusion can maintain a stable blood concentration, and the fluctuation of pain score is relatively small. At the same time, because it does not contain strong opioids, there is no risk of respiratory depression, and it can be applied to the elderly and children. Of the 60 patients, only 4 had nausea and vomiting, and 3 had dizziness. Without special treatment, the symptoms disappeared by themselves after stopping the drug. The domestic KSH medical continuous injector (fixed flow type) is a one-time-use small medical device that does not require a power source, and only relies on the elastic contraction force of the inner tube to inject drugs. The volume is 100ml, and the theoretical infusion rate is 2ml/h (ambient temperature). 30°C, infusion of 0.9% saline), the use time is about 50h. The injector is used for epidural analgesia and intravenous analgesia in other hospitals, but it has not been reported for subcutaneous analgesia.

   In this clinical study, we used the domestic KSH pump to continuously infuse the mixture of tramadol and ceramide, and achieved satisfactory analgesic effects, with less inhibition of consciousness and high patient satisfaction. The VAS scores for pain, sedation and comfort at 12, 24, and 48 hours after surgery were all less than 3 points. The average patient time with the pump was 72.17±27.19h, the dosage was 74.03±19.08ml, and the actual infusion rate was about 1ml/h. It is estimated that the ambient temperature in the ward was low (10-20°C) and the viscosity of the infusion liquid was higher. The infusion rate drops. The pumping time of PCIA group was 60.30±34.81h, the dosage was 71.50±21.34ml, the actual infusion rate was about 1.19ml/h, the pumping time of PCSA group was 76.73±29.60h, the dosage was 75.00±18.38ml, the actual infusion rate was about It was 0.98ml/h. The results showed that the actual infusion rate in the PCSA group was lower than that in the PCIA group (P<0.05), which may be caused by higher infusion resistance due to subcutaneous pressure higher than venous pressure. The method of intravenous continuous infusion analgesia has been reported in many domestic and foreign anesthesia journals, but the domestic KSH type continuous infusion pump subcutaneous continuous subcutaneous infusion analgesia has not been reported yet. Its main advantages are simple operation and stable blood concentration. The circulatory system has little impact, fewer complications, controllable dosage, and good analgesic effect. It is a postoperative analgesic method that is more suitable for hospitals at all levels.   Imported PCA pump has the advantages of reasonable design and good performance, but its price is expensive, and its application is limited to a certain extent, especially in the vast grassroots hospitals in the western region, which is more limited by price. The domestic KSH pump can obtain satisfactory clinical analgesic effect through continuous infusion of a small amount of analgesic liquid. At the same time, the price is low, which is in line with my country's national conditions, so it has a very broad application prospect. references

  1. Tsui SL, Law S, Fork M, et al. Postoperative analgesia reduces mortality and morbidity after esophagectomy. Am J Surg, 1997, 173(6): 472~8

  2. Smythe M, Loughin K, Schad RF, etc. Patient-controlled analgesia versus intramuscular analgesic therapy. Am J Hosp Pharm,1994, 51(11): 1433~40

  3. Bamberger AH, Tanellian DL, Klein K. Pain management for the postoperative patient. Tex Med, 1994, 90(4): 54~6    4. Yi Jie, Huang Yuguang, Zhao Qian. Special Equipment Required for PCA Section 1 Introduction to PCA Pump See: Editor-in-Chief Luo Ailun, Patient Controlled Analgesia-New Concept of Analgesia, p86~93

  5. Rosenow DE, van Krieken I, Stoke D, et al. Intravenous administration of lornoxicam, a new NSAID, and pethidine for postoperative pain: a placebo-controlled comparison. Clin Drug Invest 1996; 11:11-19

  6. Llias W, Jansen M. Pain control after hysterectomy:an observer-blind, randomized trial of lornoxicam versus tramadol. Br J Clin Pract 1996; 50:197-202

  7. Weber E. Double blind pilot study of parenteral administered lornoxicam in patients with pain due to acute inflammatory processes/ a randomized double blind parallel group study [study CT 55]. Nycomed Pharma A/S, 1993(data on file)

  8. Kullich W, KleinG. Die ausschuttung der korperreigenen Opiatpeptide Dynorphin und-Endorphin unter dem Einfluss des Nicht-steroidalen Antirheumatikums Lornoxicam iv. Akteul Rheumatol 1992; 17:128

  9. Bugge C. A randomized,parallel group trial with chlortenoxicam and naproxicam and naproxen in patient with pain due to bone tumors [study CT17]. .Nycomed Pharma A/S, 1993(data on file).

  10. Bugge C. An open continuation study with lornoxicam(chlortenoxicam) in patients with pain due to metastatic bone tumors [study CT72]. Nycomed Pharma A/S,1993(data on file).

  11. Ventura A, Vizzardi M, Berlusconi M. Pilot study on analgesec activity of lornoxicam. Gazzetta Medica Italiana 1991; 150: 287-291

  12. Sternieri E, Bussone G, Manzoni GC, et al. Lornoxicam, a new non-steroidal anti-inflammatory drug, in migraine prophylaxis: a double-blind mulcenter study. Cephalagia 1991; 11(Srppl)11:154-155

  13. Frenzel W. Comprehensive evaluation of satety data in patients treated with lornoxicam. Mycomed Pharma A/S, 1995(data on file).

  14. Gong Zhiyi, Ye Tiehu, Qin Xiaotao, Yu Guangxiang, Guo Xiangyang, Luo Ailun. The clinical study of lornoxicam for patient-controlled analgesia after gynecological open surgery. Journal of Chinese Academy of Medical Sciences 2001;23(5):472-475


Beijing Kelian Shenghua Medical Technology Co., Ltd   京ICP备05070151号    互联网药品信息服务资格证书号:(京)-非经营性-2017-0043