| ObjectiveThrough the evaluation of a clinical trial of epidural to sustained injection of dexmedetomidine combined with collagenase chemonucleolysis for treatment of lumbar disc herniation safety and effectivenessMethodsThe trial was randomized, double blind, placebo controlled clinical trial. According to the standard select 90 cases of lumbar disc herniation patients participated in the study. Comply with the conditions were 1:1:1 divided into dexmedetomidine fixed injection group 0.5μg/kg, dexmedetomidine fixed injection 1.0 μg / kg group or control group(placebo), were treated according to experimental design scheme.All patients were placed in the lateral decubitus position, suffering from side down, in the operation routine sterilization shop towel, to the intervertebral space as the puncture point, under local anesthesia with 16 epidural puncture needle into the epidural cavity, and then the epidural catheter was arrived epidural anterior gap(by C-arm or CT spinal angiography demonstrated catheter has to reach the lesion). After routine epidural puncture indwelling tube connection PCA pump sustained anti-inflammatory analgesic treatment for 4 days and again after C arm or CT spinal angiography confirmed the position of the catheter, and then through the epidural tube injection of collagenase 1200 U treatment. Postoperation supine, discharged without exception routine after a week, regular follow-up after operation.Drug delivery plan:Experimental group D1: epidural connection PCA pump containing 0.1% ropivacaine, 1 mg dexamethasone, dexmedetomidine 0.5μg/kg and normal saline 200 ml.Experimental group D2: epidural connection PCA pump containing 0.1% ropivacaine, 1 mg dexamethasone, dexmedetomidine 1μg / kg, and normal saline 200 ml.Control group, C: control group(dexmedetomidine injection simulation agent) regimen as experimental group D1 or D2.Note: the three groups of patients with epidural PCA analgesic pump are set to the conventional rate of 2ml/h, single 0.5ml PCA, lock time is set to 15 min.By comparing the visual analog pain score(VAS) and modified Macnab efficacy evaluation of three groups of patients with the time 24h(T1), 1 week(T2), 1 month(T3), 6 months(T4) after surgery, and the application of the pain medication, the clinical efficacy was evaluated. The adverse reactions of patients with nausea, vomiting, hypotension and tachycardia were recorded. And in the implementation of the study has always been to observe patients with or without the tail syndrome, transient neurological syndrome and other complications, to evaluate its safety.Result1, the general situation of the three groups of patients(age, gender, etc.) was not statistically significant.2, VAS scores were compared, at each time point(T1, T2, T3, T4)(D1, D2) of experimental group and control group(C) compared with the VAS score decreased significantly, with statistical significance(P<0.05) And between the different doses test group at the time points(T1, T2) and VAS score decreased significantly, there was statistical significance(P<0.05);(T3, T4) time points although the VAS score decreased, but there was no statistical significance(P>0.05)3. Comparison of curative effect of modified Macnab,At each time point(T1,T2, T3, T4), the experimental group(D1, D2) and control group(C), the excellent and good rate was statistically significant(P<0.05), at(T1,T2) the comparison between the experimental group(P<0.05), at(T4, T3) was not statistically significant(P>0.05).4, Comparison of one week after operation, patients need subsidies of analgesic drugs, the experimental group(D1, D2) the use of pethidine were significantly less than the control group(C), there was statistical significance(P<0.05) Comparison between the two groups, the use of the use of D1 and D2 compared with, there is no statistical significance(P>0.05). After a week of tramadol total dosage experiment group(D1, D2) to significantly less than the control group(c) was statistically significant(P < 0.05), and between the experiment groups compared although tramadol on postoperative week total dose(D2) less than(D1), but no statistical significance(P > 0.05).5, adverse reactions(nausea, vomiting, hypotension, heart rate is too slow), the experimental group compared with the control group without statistical significance. Three groups of patients were not found in the patients with the disease of the nervous system, such as the tail of the horse’s tail, temporary neurological syndrome and other neurological complications.Conclusion1, epidural continued injection of dexmedetomidine can effectively improve the curative effect of collagenase chemonucleolysis for treatment of lumbar disc herniation, can effectively relieve the postoperative pain, and does not increase the incidence of adverse reactions.2, different doses(0.5μg/kg 1.0 g / kg) of dexmedetomidine set for the analgesic treatment effect of lumbar disc herniation in the short term is dose related, and long-term efficacy without statistical significance. |
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