This study was conducted at the Dr. Shariati hospital, Tehran University of Medical Sciences from January to April 2016. The study protocol conformed to the ethical guidelines of the 1989 Declaration of Helsinki. Ethical approval for this study was provided by the ethics committee of Tehran University of Medical Sciences.
Patients were informed about the proposed position for the procedure during the pre-anesthetic visit. A written informed consent was obtained separately before the operation.
A total of 360 Three hundred and sixty ASA class I or II patients aged 18 to 60 years, scheduled for elective lower abdominal or lower extremity surgeries under spinal anesthesia, were enrolled in the study. Randomization was based on computer-generated codes and was concealed in envelopes, opened by the block performer before the spinal puncture. The cxclusion criteria included any contraindications to neuroaxial block, pregnancy, BMI > 35, lumbar surgical scar, and obvious lumbar scoliosis. All patients had an intravenous (IV) infusion placed and were given isotonic saline 3 mL/kg and 50µg Fentanyl before spinal anesthesia. Standard monitoring was used during spinal anesthesia. All spinal blocks were performed by 2 anesthesiologists who had experienced more than 400 spinal procedures in the TSP or SP. The anesthesiologist sat on a stool at a level to keep the interspinous space at the level of his or her eyes. Then, block performers used a 25-gauge needle with a length of 3.8 cm for local anesthetic injection, followed by a 25-gauge Quincke needle by midline approach at L2 - L3 or L3 - L4 interspace. An anesthesiology resident recorded weight, height, and the surface landmarks graded by a block performer as: easy, difficult, or impossible to palpate the lumbar spinous processes, while the patient was positioned according to the allocation group.
For TSP, patients flexed their knees approximately 90°, adducted their hips, and put their feet on a stool; the height of the bed was adjusted to provide optimal hip and lumbar flexion (
Figure 1). In SP, patients sat with their lower extremities fully flexed at the hip and knee joints while hugging their knees. In addition, both buttock and plantar surfaces of the feet were supported by the bed and forward bending (
Figure 2). In HSP, patients stretched their legs on the operating table with maximum extension of knees, adduction of hips, and forward bending. In each group, “maximum” was the greatest amount that a patient could tolerate (
Figure 3).
Depicture of Patient in Traditional Sitting Position
Depicture of Patient in Squatting Position
Depicture of Patient in Hamstring Stretch Position
The spinal procedures were performed to improve needle insertion or space identification and minimize spinal needle-bone contacts. A spinal needle-bone contact was defined as spinal needle contact against the bone, which prevented further passage. All spinal needle-bone contacts were recorded. The study was complete whenever the subarachnoid space was confirmed by observation of free flow of CSF. When there was no CSF in the needle hub or there was only a small amount of CSF with poor flow, the needle was rotated clockwise 90° and had to wait for 5 seconds. The sequence of rotation continued for another 3-quadrant rotation of 90° and waited 5 seconds after each rotation. Despite this maneuver, if there was absence of CSF or its free flow, the needle was further advanced approximately by 2 mm. The block performer was not allowed to perform a new puncture site and was restricted to pull back the needle just to the subcutaneous tissue. When a bone was encountered during any of above-mentioned attempts, the needle was withdrawn just below the skin level followed by redirection with a more cephalad angulation. If more than 5 spinal needle-bone contacts occurred the case was recorded as a failure of the position and the study was stopped.
2.1. Statistical Analysis
According to previous studies, the success rate of needle insertion without bone contact was 50% in TSP and 70% in SP. Presuming that HSP would increase this proportion to 85%, one would need to enroll 110 patients in each group for the results to be statistically significant at a power of 80% with a level of confidence of 95%. Estimating that 10% of patients may drop out of the study due to different reasons, the sample size was increased to 120 patients in each group. In this regard, with α = 0.05 and power 80%, we can estimate the difference between SP and TSP with power 90% and between TSP and HSP with power 95%.
Data was analyzed by using SPSS version 23 (SPSS Inc., Chicago, IL). Normal distribution of data was checked by the Kolmogorov Smirnov test. Independent sample t-test and Chi-square test were used for comparing demographic data. ANOVA and Post hoc Tukey test were used for comparing a number of needle bone contact and ease of intervertebral space identification. P ≤ 0.05 was considered statistically significant.