In this double-blind clinical trial, block randomization was applied as the sampling method. The sample size was calculated at 26 cases per group, using Cohen’s table (power, 80%; alpha, 0.05). This clinical trial was registered in the Iranian Registry of Clinical Trials (IRCT2015110212642N20).
The inclusion criteria were as follows: 1) willingness to participate in the study (informed consent); 2) ability to answer the verbal questions; 3) age range of 20 - 65 years; 4) being a candidate for unilateral debridement below the knee; and 5) ASA classification of I or II. On the other hand, the exclusion criteria were: 1) history of type II diabetes; 2) peripheral arterial disease; 3) coagulopathy; 4) peripheral neuropathy; and 5) incomplete sensory block after 45 minutes.
In the current study, based on the inclusion/exclusion criteria and block randomization, 52 patients were selected. After obtaining written informed consents from the patients, they were randomly categorized into 2 groups: SG, injection into the nerve 5 cm proximal to nerve bifurcation; and TPG, separate injections into TN and CPN at the popliteal fossa. All the patients received intravenous injections of midazolam (1 mg) and fentanyl (50 mcg) before nerve blocking.
Patients in both groups were positioned laterally and were monitored continuously via electrocardiography, SpO2 measurement, and noninvasive blood pressure monitoring during nerve blockade and surgery. Sciatic nerve block was performed under the guidance of both ultrasound and nerve stimulator using a posterior approach in a lateral decubitus position.
A linear probe (3 - 8 MHz, s-nerve, Sonosite, USA) with an in-plane approach and a 7-cm sonovisible needle (22-guage; Pajunk, Germany) was used to inject 15 cc of marcaine 0.5%, 15 cc of lidocaine 1%, and epinephrine 1:400,000 (30 cc in total). The needle tip was adjusted if necessary to achieve circumferential spread. In the TPG group, the patient was placed in a lateral position, and 15 cc of the solution was injected around CPN and 15 cc around TN while reaching circumferential spread. Sensory and motor block was assessed by a person blind to the experiment at 10 minutes after the injections. Then, the assessments were carried out every 5 minutes for 45 minutes.
Sensory block was assessed in TN and CPN regions, using the pinprick test with the following scorings system: 0, no change detected; 1, reduced sensation; and 2, complete absence of pinprick sensation. In addition, motor block was scored as follows: 0, no change compared to the baseline; 1, reduced force and movement; 2, complete absence of force and movement. Time of block onset was defined as reaching a sensory score of 2 during 45 minutes in both TN and CPN zones.
Duration of imaging was measured from the time of touching the ultrasound probe until obtaining a proper image. Duration of needling was measured from the moment the needle touched the skin until the end of local anesthetic injection. Moreover, duration of block was defined as the total time of imaging and needling. Frequency of needling and complications, including paresthesia and vascular puncture, was documented for each participant.
The data were analyzed using SPSS version 13. Kolmogorov-Smirnov test was used to assess the normal distribution of variables. The parametric variables were presented as mean ± standard deviation (SD) and analyzed by student t test. Nonparametric variables were analyzed using Chi square or Mann-Whitney U test. P value less than 0.05 was considered statistically significant