Comparison of the efficacy of paracervical block in first-trimester surgical abortion to endometrial sampling and its relation to anxiety
Sule Atalay Mert MD*, Berna Dilbaz Prof. Dr
Etlik Zubeyde Hanim Obstetrics & Gynecology Training and Research Hospital, Department of Reproductive Endocrinology, Ankara, Turkey.
*Corresponding author
*Sule Atalay Mert, M.D, Etlik Zübeyde Hanım Obstetrics & Gynecology Training and Research Hospital Reproductive Endocrinology Department, Ankara, Turkey.
DOI: 10.55920/JCRMHS.2023.06.001266
Abstract
Background: Psychological support, premedication with analgesics, and local anesthesia are the most widely used methods for pain management during gynecological surgeries. The World Health Organization's (WHO) Safe Abortion Technical and Policy Guidance for Health Systems Guideline recommends the use of manual vacuum aspiration for first-trimester induced abortions for pain management. We aimed to compare the efficacy of lidocaine used for pain management in first-trimester voluntary termination to endometrial sampling and its relation to anxiety.
Material and Methods: One hundred twenty patients were enrolled in the study. 60 patients who had a first-trimester voluntary surgical abortion were recruited to the study as Group 1. In comparison, 60 patients who had endometrial sampling due to abnormal uterine bleeding were taken as Group 2. The patients were asked to complete the Beck Anxiety Inventory (BAI) before the procedure. Patients in both groups had a paracervical block with a 1% lidocaine injection prior to manual vacuum aspiration (MVA). The pain intensity was evaluated with the Visual Analogue Score (VAS) at each procedure step.
Results: The BAI scales of both groups were similar (8.95±10.0 vs. 8.8± p>0.05). The VAS scores measured at the time of application of the tenaculum to the cervix (VAS1), the injection of the paracervical block (VAS2), and the insertion of the cannula (VAS3) were similar in both groups. However, VAS scores measured during aspiration (VAS4), half an hour after the procedure (VAS5), and overall pain related to the procedure (VAS6) were found to be lower in Group 1 (p > 0.01). In the induced abortion group, all VAS values were found to be correlated with the BECK anxiety inventory.
Conclusion(s): It was concluded that paracervical block was effective, especially in intrauterine aspiration and total pain control, but the effectiveness was less evident in the induced abortion group due to existing anxiety.
Keywords: Induced abortion, endometrial sampling, paracervical block, pain management, anxiety.
Introduction
Paracervical block (PCB) with local anesthetics is commonly used for pain management. It blocks sensation at the internal cervical ostium, just before nerves enter the uterus, and also causes nerve capsule distension. (1-3). Paracervical saline instillation may help ease pain during dilation by causing nerve capsule distension. However, local anesthetics are still needed during evacuation. (4)
World Health Organization (WHO) Safe Abortion: Technical and Policy Guidance for Health Systems The guideline recommends the use of manual or electrical vacuum aspiration for first-trimester surgical abortions and supports the use of analgesics, local anesthesia, and/or conscious sedation supplemented by verbal reassurance for pain management (5). Although electrical vacuum aspiration is as effective as manual vacuum aspiration (MVA), the latter is associated with less pain in pregnancies under 63 days of gestation (6). General anesthesia may also be used in cases that require a longer period of pain control, but the higher incidence of mortality and severe morbidity related to general anesthesia should not be underestimated when choosing a method for pain control. The pain during MVA performed for first-trimester surgical abortion was found to be related to age, parity, previous vaginal delivery, gestational age of the current pregnancy, the duration of the procedure, and psychological status (7–10).
Endometrial sampling procedures (ESP) are often preferred for the differential diagnosis of uterine pathologies that cause abnormal uterine bleeding. Pain associated with this procedure may arise due to the application of the tenaculum to the cervix, traction of the cervix in order to straighten the cervical-uterine angle, or dilatation of the cervix if required. Endometrial sampling can also be performed by using a Karman-type cannula-curette and manual vacuum aspirator, as well as various techniques like a low-pressure pipette, high-pressure vabra aspirators, and sharp curettage (4–8). Various biopsy techniques have been developed in order to obtain adequate tissue samples with minimal pain (11). Conscious sedation, paracervical block, or intrauterine anesthetic application are often preferred for pain management (12, 13).
This study aims to compare how effective paracervical block is in first-trimester surgical abortions using MVA and Karman cannulas. It also explores how anxiety influences pain perception in both groups.
Materials and Methods
The study was conducted at a tertiary-level women’s hospital after obtaining institutional approval from the local ethics committee with the ID number 172 and date of March 25, 2014. Sixty patients aged 18 to 44 who applied to our outpatient clinic for voluntary pregnancy termination and 60 patients scheduled for endometrial sampling were included in the study. The aim and protocol of the study were explained to the volunteering patients, and informed consent was obtained prior to the recruitment. Patients with bleeding diathesis, pathology in pain perception, or patients who underwent surgery under general anesthesia due to intrauterine ex fetus, blighted ovum, or missed abortion were excluded from the study. Socio-demographic characteristics and obstetric history of the patients (age, gravidity, parity, number of alive children, number of previous surgical and spontaneous abortions, uterine interventions, mode of previous deliveries, date of the last menstrual period), findings of the physical and gynecological examinations, and ultrasonographic evaluations were all recorded. Pre- and post-procedure serum hemoglobin (Hb) and hematocrit (Hct) measurements were carried out, and the results were recorded.
Paracervical Block Procedure
Patients were assessed in the lithotomy position. Following the insertion of a sterile bivalve speculum, the vagina and cervix were cleaned with an antiseptic solution. Before holding the cervix with the tenaculum, 2 ml of tamponade lidocaine was injected at twelve o’clock in the cervix. After holding the same point with a tenaculum, 18 ml of lidocaine was injected into the cervix at 4 different sites (2, 4, 8, and 10 o’clock). The injections were performed slowly to a depth of 3 cm within 60 seconds. Aspiration of the uterine cavity was performed 3 minutes after the paracervical block. No premedication was given to patients before the procedure. All the patients were followed up for 30 minutes after the curettage procedure before discharge to record their vital signs and any complications (respiratory arrest and bradycardia) or side effects that occurred.
Visual Analogue Scale (VAS)
The patients were asked to evaluate their pain level on a 100-mm visual acuity scale (VAS). The pain levels were rated from 0 (no pain) to 10 (the worst pain). The evaluation of pain was carried out in six stages: VAS1, when the cervix was grasped with the tenaculum; VAS2, during paracervical lidocaine injection; VAS3, at the time of insertion of the cannula into the cervical canal; VAS4, during evacuation; VAS5, 30 minutes after the procedure; and VAS6, overall pain evaluation.
Beck Anxiety Inventory (BAI)
The validated Turkish version of the Beck Anxiety Inventory, including 21 questions, was given to patients before the procedure to evaluate the level of anxiety and its effect on the paracervical block (14). The research team classified the patient's level of anxiety based on the total points awarded on the scale. The classification was as follows: 0–7 = no anxiety; 8–15 = mild anxiety; 16–25 = moderate anxiety; 26–30 = severe anxiety.
Statistical analysis
Statistical analysis of the data was done using SPSS for Windows 11 and 5 packaged programs. The comparison of two normally distributed continuous variables was done using the independent T-test. Mann-Whitney A U test was used for the comparison of abnormally distributed data. Kruskall-Wallis variance analysis was used for the comparison of abnormally distributed continuous variables of more than two. Also, a chi-square test was performed to evaluate the relationship between categorical variables. The Pearson correlation test was performed for the relationship between the Beck Anxiety Inventory and VAS values. P< 0.05 was accepted as statistically significant.
Results
Although the mean age of Group-1 was found to be statistically significantly lower than Group-2 (31,14 ± 6.33 versus 38,68 ± 6.37, p < 0.001), there was no statistically significant difference between the two groups with respect to gravidity, parity, number of induced and spontaneous abortions, stillbirth, or alive children (p > 0.05) (Table 1). More than two-thirds (69.7%) of the patients in Group 2 had no history of pregnancy termination, whereas 60.3% of the patients in Group 1 had at least one before.
The VAS scores of the two groups were compared at each step, and VAS scores during aspiration (VAS4), half an hour after the procedure (VAS5), and the overall score (VAS6) were statistically significantly lower in Group 1. No statistical difference was found between the VAS1, VAS2, and VAS3 scores of the two groups (Table 2). In both groups, VAS scores were highest at the stage of aspiration (VAS 4).
The patients were grouped according to their ages: 20–30, 31–40, and above 40. No statistically significant difference was observed for the VAS scores in any age group between Group 1 and Group 2 (P > 0.05). VAS scores were independent of the age of the patients.
VAS scores of the patients within each group were compared according to the mode of delivery, either vaginal delivery (VD), cesarean section (C/S), or vaginal delivery followed by cesarean section (VD + C/S). In Group 1, the VAS6 score was statistically significantly lower in women with previous VD compared to the other groups (VD: 29.46 vs. nulliparous: 58.0, C/S: 31.22, VD+C/S: 41.2, p = 0.015). In Group 2, there was no statistically significant difference among the patients at all VAS scores (p > 0.05).
The patients in Group 1 were classified into three groups according to the gestational week (<7 weeks, 7 weeks, and >7 weeks). There was no statistically significant difference in VAS scores with respect to gestational weeks (P › 0.05).
Table 1: Comparison of the demographic and obstetric characteristics of Group-1 (induced abortion) and Group-2 (endometrial sampling).
Independent T-test was applied , *p< 0.05, statistically significant.
**VTOP: Previous voluntary termination of pregnancy.
Table 2: Comparison of VAS scores of Group-1 (induced abortion) and Group-2 (Endometrial sampling).
Independent T-test was applied *p<0.005 statistically significant
Table 3 : The distribution of VAS scores according to the grouped Beck Depression Scale in Group-1 and Group-2.
GrupAàMild anxiety (Beck Score 0-21), Grup BàModerate + severe anxiety (Beck Score 22-63).
Table 4: Correlation between gestational weeks, VAS values and Beck anxiety inventories of Group 1 (induced abortion) patients.
VAS: Visual Analogue Scale Beck Inv: Beck Anksiety Inventory
The patients in Group 2 were classified according to the endometrial thicknesses measured by transvaginal ultrasonography prior to the procedure (2–8 mm, 9–14 mm, ≥15mm). Almost more than half of the patients (54%) had an endometrial thickness of 2–8 mm. When the VAS scores were compared, no statistically significant difference was found between the three groups with respect to endometrial thickness (p › 0.05).
Using the Beck Anxiety Inventory, no statistically significant difference was found between Group-1 and Group-2 VAS scores (p > 0,005) (Table 3). The mean total anxiety scores were 8,95±10,026 in Group 1 and 8,88±7,674 in Group 2. The patients with moderate and severe anxiety were 8 (13.3%) in Group 1 and 4 in Group 2 (7.7%). The majority of patients (85.7% in Group 1 and 92.3% in Group 2) had mild anxiety, and no statistically significant difference was observed between the two groups (p = 0.372). However, for Group 1, all VAS scores are related to the Beck anxiety inventory (detailed in Table 4).
When the preoperative and postoperative Hb and Hct levels of patients in two groups were compared, in Group 1, both Hb and Hct levels were significantly decreased after the operation compared to the preoperative period (12.8±0.76 vs. 11.7±0.81 g/dL, 37.8±2.8 vs. 35.1±2.1, p = 0.001). No statistically significant differences were found in the Hb and Hct values before and after the operation in Group-2 patients (12.2±1.5 vs 11.6±1.6 g/dL, 37.1±4.5 vs 34.7±4.9, respectively, p>0.05).
In terms of complications related to paracervical blockage, respiratory arrest, or bradycardia, none were observed in any of the patients, whereas bleeding from the site of injection was more frequent in Group 1 (19% vs. 49.3%, p< 0.01).
Discussion
Since the approval of dilatation and curettage (D&C ) operations at the end of the 1950s, many new techniques have been developed (15). Office-based methods using MVA and pipeline aspiration catheters have become standard methods as they are less invasive and painful and are related to a decreased need for anesthesia (16, 17). Manual vacuum aspiration was initially introduced for the management of incomplete miscarriages in the 1970s, but since then it has been widely used for the management of miscarriages and first-trimester pregnancy terminations. Pain may occur during cervical dilatation, and this pain may be aggravated during aspiration due to uterine contractions.
The paracervical block is used for endometrial biopsy and endometrial curettage, as well as pregnancy termination (18). In a study, 120 patients had premedication with oral ibuprofen and lorazepam prior to first trimester abortions (19), then 60 patients had a paracervical block with 2 ml of 1% lidocaine, while 60 had no regional anesthesia. Paracervical block significantly reduced the pain felt during dilatation and aspiration and increased total satisfaction scores. In a randomized clinical study by Cansino et al. (20), half of 50 patients below 11 gestational weeks had a paracervical block with lidocaine after oral ibuprofen administration, and the other half had a paracervical block with lidocaine and ketorolac following placebo. No significant difference was detected between the two groups in terms of postoperative pain and total satisfaction scores (p = 0.93). However, the group who received lidocaine and oral ibuprofen had a significant reduction in pain scores during cervical dilatation. In our study of induced abortion cases (Group 1), the highest VAS score was noted during evacuation (VAS4). The pain scores during the insertion of the cannula (VAS3) and injection of the local anesthetic (VAS2) followed VAS4. Endometrial sampling group (Group 2): VAS4 had the highest noted score, followed by VAS3 and VAS6.
Açmaz et al. (21) divided 111 patients with 5-7 gestational weeks who applied for termination of pregnancies into 5 groups. The pain scores in four groups that received different analgesic procedures were compared with those in the control group that received no medication. While all analgesic procedures significantly reduced pain in the postoperative period, paracervical block reduced pain scores in both the intraoperative and postoperative periods during the procedure. However, in the presented study, the pain scores decreased in both groups after evacuation. Although the VAS scores after evacuation (VAS5, VAS6) were lower in Group-1 in comparison to Group-2, the overall pain evaluation was low (VAS6) in both groups when compared to the scores during evacuation. Renner et al. reported improvement in mean pain scores during dilation and aspiration with carbonated lidocaine in the first trimester of abortions (22). The updated Cochrane Review similarly showed that paracervical block with local anesthetic reduced pain during dilatation and uterine intervention when compared with placebo; however, the effect of local anesthesia on postoperative pain when compared to placebo has not been shown yet (23). Likewise, when the effects of general anesthesia, sedation, or analgesia, regional or paracervical block anesthetic techniques used for surgical evacuation of incomplete miscarriage were compared, paracervical block showed no effect on postoperative pain (24).
Nulliparity and young age were reported to be risk factors for increased pain perception, while previous vaginal delivery was related to decreased pain in patients who had induced abortions (8, 9). Except for their young age, similar findings were observed in Group-1 patients in the present study. However, no correlation was found between the VAS scores and gestational age of the terminated pregnancy in Group 1 and endometrial thickness in Group 2. Renner et al. reported that regardless of the gestational age, paracervical block was found to be effective in first-trimester surgical abortions, but pain control was better at earlier gestational weeks (25). In a study comparing the effect of transcervical intrauterine anesthesia with a placebo in patients undergoing an endometrial biopsy, a moderately positive correlation was found between endometrial thickness (< 5mm vs. ≥ 5 mm) and pain scores. The authors suggested that this might be related to more vigorous curating in patients with thick endometrium (26).
In various studies, preoperative high anxiety was reported in patients who underwent induced abortion. Allen et al. reported a pain score of 6.2 (on a scale of 1–10) in 105 women who had suction curettage for pregnancy <14 weeks under local anesthesia, while this score was 6.8 for lorazepam and 5.7 for intravenous sedation. The positive predictors of pain were stated as increased preoperative anxiety, depression, and expected pain and a lower volume of local anesthesia used (10 mL vs. 20 mL) (27). Lauzon et al. (28) found that 56.9% of the women were anxious before the operation, while this ratio decreased to 41.7% in the 3rd postoperative week. In our study, using the Beck Anxiety Inventory (BAI) we found that only a minority of the patients in both groups had moderate to severe anxiety. No significant relationship was found between the VAS scores and anxiety status in both groups.
To the best of our knowledge, there is no study comparing the efficacy and safety of the paracervical block in induced abortion (pregnancies) to endometrial sampling in the Anglo-Saxon literature. In conclusion, local anesthesia with the paracervical block is a safe and effective method for the termination of pregnancy and endometrial sampling, as it is efficient in reducing pain during the intraoperative and postoperative periods, especially during the intrauterine evacuation stage. The weakness of this study might be the restricted number of patients and the lack of longer-term follow-up. Moreover, comprehensive studies with a larger number of patients are required in order to define the most effective and safe method of pain management during minor intrauterine surgical interventions.
Statements and Declarations
Funding: The authors declare that no funds, grants, or other support were received during the preparation of this manuscript.
Competing Interests: The authors have no relevant financial or non-financial interests to disclose.
Author Contribution:
S. Atalay Mert: Data collection, analysis, writing, and editing
B. Dilbaz: Writing and editing
Ethics approval: This study was performed in line with the principles of the Declaration of Helsinki. Approval was granted by the Ethics Committee of University B (Date. 25.03.2014/No.172).
Consent to participate: nformed consent was obtained from all individual participants included in the study.
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