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Original Research |
1 Department of Radiology, School of Medicine, University of São Paulo,
R: Vicente Oropallo, 171-74 pz - V. São Francisco, São Paulo,
Brazil 05351-025.
2 Department of Gynecology and Obstetrics, School of Medicine, University of
São Paulo, São Paulo, Brazil.
Received March 5, 2005;
accepted after revision May 9, 2005.
Address correspondence to J. F. L. de Mello, Sr.
(jfredluc{at}uol.com.br).
Abstract
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SUBJECTS AND METHODS. Eighty-nine patients were randomly assigned to one of three groups. In group 1, 30 patients underwent the technique performed with a metal cannula without anesthetic; in group 2, 29 patients underwent the technique performed with a metal cannula with previous paracervical anesthetic block; in group 3, 30 patients submitted to the procedure performed with a flexible balloon catheter. Each patient completed two questionnaires, Q1 and Q2: Q1 assessed their personal, clinical, and surgical history, and Q2 provided the visual analog scale (VAS) for pain assessment. The investigator also evaluated discomfort at each potentially painful stage of the procedure based on the patient's verbal expression, physical manifestations, or both.
RESULTS. In terms of global discomfort experienced during hysterosalpingography, group 1 had the highest mean VAS score, whereas scores did not significantly differ between groups 2 and 3. During cervical grasping, group 2 experienced less discomfort than group 1. A comparison of pain associated with cervical grasping and balloon inflation (group 3 only) revealed that the highest levels of discomfort occurred during cervical grasping without anesthesia (group 1), followed by balloon inflation inside the cervix (group 3), and, last, cervical grasping after paracervical block (group 2).
CONCLUSION. Performing hysterosalpingography with a flexible balloon catheter or metal cannula with previous paracervical block produced similar levels of pain; however, both techniques appear to be more comfortable than the traditional technique (i.e., metal cannula without anesthesia).
Keywords: balloon catheter • hysterosalpingography • infertility • metal cannula • pain management • paracervical blockage • pelvic imaging
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Many hysterosalpingography techniques have been compared. For example, the traditional technique performed with a metal cannula has been compared with one in which a flexible intrauterine catheter with a balloon or vacuum cannula is used, providing a more comfortable examination with comparable technical quality. Although some of these techniques have produced satisfactory results, they have not completely replaced the use of a metal cannula (i.e., traditional technique) because of its wide availability, low cost, and sometimes preferability in the evaluation of the cervix and uterine cavity [5-8].
The use of a paracervical block has been described for various obstetric and gynecologic procedures. Given its favorable results as an anesthesia for first-trimester uterine curettage [9], outpatient hysteroscopy [10], and labor analgesia [11], we hypothesized that it may be useful in reducing discomfort associated with hysterosalpingography. The purpose of this study was to compare levels of discomfort experienced by patients who underwent hysterosalpingography according to one of three techniques. Two—use of a metal cannula and use of a flexible intrauterine balloon catheter—have been widely studied; the third technique involves use of a metal cannula with prior paracervical block.
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Per the routine protocol, all patients were offered 30 drops of an oral antispasmodic (hyoscine butyl bromide) associated with an analgesic drug (dipyrone) at the hospital 1 hour before the procedure. The procedure was always performed between the seventh and 10th day of the menstrual cycle, except for one patient with amenorrhea, whose serum ß-HCG test was negative.
The study included patients between 18 and 45 years old with a diagnosis of infertility who had been referred for hysterosalpingography. Exclusion factors included use of any medications (except for the hyoscine butyl bromide and dipyrone) that increases or decreases neurologic thresholds of pain; and any disease process associated with increasing or decreasing thresholds of pain, whether central (such as depression or hypothyroidism) or local (such as endometriosis, constipation, chronic pelvic pain, lower back pain, or diabetes). Patients suspected of complete uterine synechiae or amenorrhea after curettage and patients submitted to a technique other than the one designated for the specific day (in situations in which the use of another specific catheter was appropriate) were also excluded.
The characteristics of the groups and respective techniques are as follows.
Group 1
Thirty patients underwent hysterosalpingography via the metal cannula
technique with no anesthesia. The technique consisted of bimanual examination,
followed by placement of the speculum, vaginal antisepsis, grasping of the
anterior lip of the cervix with Pozzi forceps, coaptation of the metal cannula
into the external cervical orifice for injection of a hydrosoluble iodinated
contrast medium (38% meglumine iodamide) and cervical traction. The contrast
agent was introduced under fluoroscopy to observe and obtain radiographic
films of three different stages of contrast enhancement: an underfilled stage,
with approximately 2 mL of contrast; an early tubal filling stage, before
overflow of the contrast agent into the cavity; and a well-filled stage, with
disclosure of the uterine cavity and the contrast agent overflowing into the
peritoneal pelvic cavity. A residual stage disclosed contrast medium in the
pelvic cavity before and after a positional maneuver (in the supine position,
the patient is rotated in her longitudinal axis to prone and then to supine
position, twice) to show the free contrast medium dispersion around the bowel
loops.
Group 2
Twenty-nine patients underwent hysterosalpingography via the same metal
cannula technique as group 1 except a paracervical block was performed before
the grasping of the cervix was performed. This block was achieved by the
submucosal injection of 3 mL of 1% lidocaine in the vaginal cavity around the
cervix, at the 2-, 4-, 8-, and 10-o'clock positions
(Fig. 1).
Group 3
Thirty patients underwent hysterosalpingography in which the contrast
medium was instilled through a flexible intrauterine balloon catheter (size
7-French or 5-French H/S Catheter Set No. 61-5007, Ackrad Laboratories). After
speculum placement and vaginal antisepsis, a stent was introduced into the
cervical canal and the balloon was inflated to the level of the cervical or
uterine isthmus (this depends on the balloon remaining firmly located within
the cervix), This was followed by injection of a contrast medium under
fluoroscopy, as described for group 1.
All examinations were performed by the same gynecologist from the Department of Radiology of HCFMUSP.
Each patient completed two questionnaires, Q1 and Q2. The first one, Q1, administered a few minutes before the procedure, evaluated the patient's personal information, medical complaints and duration, gynecologic and surgical background, and medications used. In Q2, completed immediately after the procedure, the patient provided information about the location, quality, and amount of pain experienced during or after the examination. The visual analog scale (VAS) [12] was used to quantify the pain and was applied at the end of the examination. The VAS consists of a line with the numbers 0 at one end and 10 at the other. After being told that 0 represents the complete absence of pain and 10 represents the worst pain imaginable, each patient was asked to mark the position on the line corresponding to the worst pain experienced during the examination. The VAS score was achieved with a 0.5-cm graduate rule:
In a third questionnaire, Q3, the investigator evaluated the pain or discomfort felt at each potentially painful stage of the examination (speculum placement, anesthesia, balloon inflation, cervical grasping and traction, well-filled uterine contrast medium stage) based on verbal expression or physical manifestations for both. Pain was grouped into one of three categories: level 1, absence of pain—expressed verbally; level 2, discomfort—expressed verbally and spontaneously; and level 3, painful—any exalted reference to pain, including exalted verbal expression, associated physical manifestations (e.g., changes in position, body movements), or both.
Statistical analysis—Descriptive analyses: These analyses involved determination of minimum and maximum values and calculation of the means and SDs for quantitative variables (age, VAS scores). For qualitative variables (presence or absence of a specific parameter), absolute and relative frequencies were calculated. Comparative analyses: The chi-square test and Fisher's exact test [13] were used to evaluate group homogeneity. Analysis of variance was used to compare means of the three independent groups, and the Bonferroni adjustment [13] was used for multiple comparisons.
All tests were performed with a 5% significance level.
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For the cervical grasping stage, performed only in groups 1 and 2, group 1 had more responses classified as uncomfortable or painful. Balloon inflation, performed only in group 3, was classified as uncomfortable by 23.3% of patients and painful by 10%. Comparison of pain caused by balloon inflation versus grasping of the cervix revealed that cervical grasping after anesthesia (paracervical block) was associated with the least pain, followed by balloon inflation inside the cervical canal, with cervical grasping without anesthesia being the most painful stage (Table 2). Vaginal punch and anesthetic injection, performed only in group 3, was described as uncomfortable by 31% of the patients, but was never described as painful (Table 2). The frequency at which the well-filled cavity contrast stage was classified as uncomfortable or painful did not significantly differ among the three groups.
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Studies evaluating pain are greatly biased by the large number of variables influencing pain. These include local and systemic sensitizing and desensitizing factors, differences in individual physical susceptibility, and the subjective nature of pain. It is defined as "an unpleasant sensorial and emotional quality, associated or described in terms of real or potential tissue lesions" [15]. Difficulty in adapting pain assessment scales to several techniques and the varying social-cultural groups to whom they are applied also can bias pain assessment.
In this study, randomization constituted an attempt to obtain group homogeneity, mainly regarding sensitivity to pain. Comparison of potential pelvic and systemic sensitizing factors (e.g., prior pelvic surgical procedures, tubal ligation, labors, cervical manipulations; coexisting constipation, dysmenorrhea, hypothyroidism, diabetes) revealed that the three groups had similar characteristics (Table 1). Group homogeneity was also tested by evaluating the response to placement of the speculum, a common step experienced by all patients. Their similar responses (Table 2) further support the notion that pelvic sensitivity was similar among the three study groups.
Quantifying pain with the VAS revealed that group 1, in which cervical grasping was performed with a metal cannula without previous anesthesia, had the highest mean VAS score at 6.8. No difference was found between the groups who received a paracervical block or flexible balloon catheter, with mean VAS scores of 3.9 and 4.3, respectively (Table 3). Similarly, Cohen et al. [6] found that the VAS score for pain associated cervical grasping using a metal cannula was significantly greater than that associated with cervical grasping using a vacuum cannula (6.8 vs 3.2, respectively; p < 0.01). On comparing pain associated with use of the flexible balloon catheter versus the metal cannula, Varpula [16] obtained VAS values of 3.8 and 5.2, respectively (p < 0.01). However, in this same study, patients who underwent the balloon catheter technique experienced a significantly higher rate of postprocedural cramps several hours after the examination than the group of patients who underwent cervical grasping with the standard cannula (5.3% for balloon vs 1.7% for cannula; p < 0.01).
The proposed use of a method for evaluating pain based on individuals' spontaneous behavioral reactions to an acute event (Q3) has not been addressed by the literature; it arises from the need to assess pain during different potentially painful times without interruption of the examination and to validate results of the subjective pain scale through observation of the subject's reactions. Although scientific validation of this method is still required, the present evaluation has produced some relevant information. Namely, pain associated with cervical grasping appears to be reduced with use of a prior paracervical block (Table 2).
Classification of the discomfort associated with the great cavity contrast-filling stage of hysterosalpingography was similar among the three groups. Therefore, the paracervical block did not appear to have an anesthetizing effect on the uterine body and fallopian tubes [11]. We also found that the vaginal (sac) punch and injection of the anesthetic led to some discomfort (31% classified it as "uncomfortable"); however, no comparative analysis of this stage was performed. As observed in previous studies [16], balloon inflation inside the cervical canal also caused some discomfort; therefore a comparison between balloon inflation in the cervix and the cervical grasping was performed as shown in the Table 2.
The results from this study suggest that pain during hysterosalpingography performed with a metal catheter and prior paracervical block is similar to that associated with hysterosalpingography performed with a flexible balloon catheter. However, the metal cannula technique cannot be entirely replaced by the one using a balloon catheter. Some situations require a metal catheter, including when the balloon cannot be properly positioned within the cervical canal, when intense uterine flexion requires traction and uterine rectification, and when evaluation of the uterine cervical isthmus is recommended [5-7]. In addition, the cost of using a balloon catheter is higher than the cost of using a metal cannula [5, 16], even with use of a local anesthetic block. Based on these arguments, we conclude that the paracervical block expands the metal cannula technique's scope of use, offering low cost and versatility with a level of pain similar to that associated with use of a flexible balloon catheter.
In conclusion, hysterosalpingography performed with a flexible balloon catheter or a metal cannula with previous paracervical block produces similar levels of pain; however, both techniques appear to be more comfortable than the traditional technique of a metal cannula without anesthetic.
Acknowledgments
We wish to thank Walther Ishikawa from the Department of Radiology, School
of Medicine, University of São Paulo, for the illustration created for
Figure 1.
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  J. E. Silberzweig Incidence of Pain During Hysterosalpingography Using a Balloon Catheter Am. J. Roentgenol., July 1, 2007; 189(1): W48 - W48. [Full Text] [PDF]
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J. F. L. de Mello Sr., M. S. Abrao, and G. G. Cerri Reply Am. J. Roentgenol., July 1, 2007; 189(1): W49 - W49. [Full Text] [PDF]
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