|Year : 2016 | Volume
| Issue : 3 | Page : 713-716
Comparison of 1% lidocaine paracervical block and NSAIDs in reducing pain during intrauterine device insertion
Mohamed M Fahmy1, Nabih I El Khouly1, Ragab M Dawood1, Mohamed H Radwan2
1 Department of Obstetrics and Gynecology, Faculty of Medicine, Menoufia University, Menoufia, Egypt
2 Department of Obstetrics and Gynecology, Student Hospital, Menoufia University, Menoufia, Egypt
|Date of Submission||21-Jun-2015|
|Date of Acceptance||04-Jul-2015|
|Date of Web Publication||23-Jan-2017|
Mohamed H Radwan
Department of Obstetrics and Gynecology, Student Hospital, Menoufia University, Menoufia, 32511
Source of Support: None, Conflict of Interest: None
Pain with intrauterine device (IUD) insertion may be a barrier to widespread use. Our objective was to evaluate the efficacy of 1% lidocaine paracervical block for pain relief with IUD insertion compared with NSAIDs.
The IUD provides long-term, reversible contraception equal in efficacy to tubal sterilization. The IUD is one of the safest, least expensive, and most effective contraceptive methods available. The IUD is often an excellent choice for women who do not anticipate future pregnancies but wish not to be sterilized.
Patients and methods
We performed a randomized clinical controlled trial of women undergoing IUD insertion. Participants were randomly assigned to receive either 10 ml of 1% lidocaine paracervical block or oral naproxen or placebo tablets before IUD insertion. Pain scores were measured using a 10-point visual analogue scale at various time points of procedure (speculum placement, tenaculum placement, during IUD insertion, and 15 min after the procedure).
Of the 150 participants randomized, 50 women received the paracervical block, 50 women received NSAIDs, and 50 women received placebo tablets before IUD insertion. Groups were similar in age, parity, ethnicity, education, and complications. Pain scores were similar among the three groups at tenaculum placement (mean ± SD = 4.84 ± 1.39, 4.76 ± 1.28, and 4.70 ± 1.21, respectively; P = 0.938) as well as during insertion (mean ± SD = 5.30 ± 1.61, 4.90 ± 1.24, and 5.16 ± 1.20, respectively; P = 0.460). These results did not differ during speculum placement and after procedure.
1% lidocaine paracervical block, as well as NSAIDs, before IUD insertion does not decrease pain scores.
Keywords: intrauterine device, lidocaine, NSAID, pain, paracervical block
|How to cite this article:|
Fahmy MM, El Khouly NI, Dawood RM, Radwan MH. Comparison of 1% lidocaine paracervical block and NSAIDs in reducing pain during intrauterine device insertion. Menoufia Med J 2016;29:713-6
|How to cite this URL:|
Fahmy MM, El Khouly NI, Dawood RM, Radwan MH. Comparison of 1% lidocaine paracervical block and NSAIDs in reducing pain during intrauterine device insertion. Menoufia Med J [serial online] 2016 [cited 2020 Apr 3];29:713-6. Available from: http://www.mmj.eg.net/text.asp?2016/29/3/713/198788
| Introduction|| |
Intrauterine device (IUD) is a highly effective contraceptive method with lower rates of discontinuation compared with other reversible methods. Although IUD offers safe and effective contraception, it remains an underutilized method of contraception in the USA , . Evidence supports the use of IUDs as a first-line contraceptive option ,,,.
There are several factors that may contribute to the low prevalence of IUD use in the USA, such as fear of pain during insertion, and some providers avoid using IUDs in women with potential risk for pain, such as nulliparous women , .
There are two types of IUD: copper or medicated IUD. In the UK, there are over 10 different types of copper IUDs available. In the UK, the term IUD refers only to these copper devices. Hormonal intrauterine contraception is considered to be a different type of birth control and is labeled with the term intrauterine system , .
There are several steps that cause pain or discomfort to the patient during IUD insertion, such as speculum insertion, tenaculum application, manipulation of the cervix, and sounding of the uterus. In addition, some studies suggest that parity may play an important role in difficulty of insertion , and the risk for severe pain with insertion , . Pain management techniques during IUD insertion include NSAIDs , , paracervical administration of local anesthetics  , and preprocedural misoprostol administration , .
A commonly used method for pain control for other minor gynecological procedures in the USA is paracervical block containing local anesthetics. There are several variations in the administration of paracervical block. These variations include the location of the administration, the depth of administration, the type of anesthetic used, and the amount of anesthetic used. It is possible that a paracervical block may provide pain control during IUD insertion  .
Different ways of reducing pain during IUD insertion have been explored. These include drugs that reduce cramping of the uterus (NSAIDs), drugs that soften and open the cervix, and drugs that numb the cervix. Prophylactic NSAIDs, as studied, do not appear to reduce pain during IUD insertion ,,,,,,,. The use of misoprostol to prime the cervix in addition to diclofenac before IUD insertion did not appear to reduce pain and may increase side effects  . The purpose of our study was to evaluate whether 1% lidocaine paracervical block improved IUD insertional pain scores compared with NSAIDs.
| Patients and methods|| |
We performed single-site randomized controlled trial on women undergoing IUD insertion (copper T 380A) between beginning of February and end of October 1 st 2014 in student hospital Menoufia University. The study population consisted of 150 women who attended the outpatient clinic of the hospital for copper IUD insertion. Patients were considered eligible if they fulfilled the following criteria: (a) alert, oriented, and co-operative to respond to the visual analogue scale (VAS); (b) signed the informed consent to participate in the clinical trial before entering the study; and (c) willingness to be randomized and complete study questionnaires.
Participants were excluded from participation if they were ineligible for an IUD by accepted criteria of our institution, such as lidocaine allergy, copper allergy, current cervicitis, pelvic inflammatory disease within 3 months, uterine anomalies, pain medication within 6 h before insertion, history of cervical surgery, and contraindication to study medications.
The approval of the local ethics committee of our hospital and oral consent of the patients was acquired. Written consent was taken from every patient before being enrolled in the study. Every enrolled patient was informed that she had the right to withdraw herself from the study at any point with no affection of the quality of service. Participants in the study groups were randomly assigned using labeled opaque envelopes to receive either 1% lidocaine paracervical block, NSAIDs, or placebo tablets.
Sample size was calculated using online statistics calculator guided by power of the test = 80%, confidence interval = 95%, and α (type 1) error. A total of 150 participants were assessed for eligibility and then randomized into three groups: group A received 10 ml of 1% lidocaine paracervical block before insertion of IUD (injection sites at the cervicovaginal junction typically at the 4 and 8 o'clock positions), followed by 3-min waiting period between the administration of the paracervical block and IUD insertion; group B received oral NSAIDs such as naproxen 45 min before IUD insertion; and group C received placebo tablets.
After informed consent was obtained and before IUD placement in the standard manner, we gave participants a 10-point VAS and asked them to indicate their current pain level and anticipated pain level with speculum placement, tenaculum placement, IUD insertion, and 15 min after procedure.
All participants were scheduled for a follow-up visit 1 week after their insertion. Those who did not complete this follow-up visit were contacted through telephone to assess for any complications related to their insertion (i.e., perforation, infection, and expulsion).
The collected data were tabulated and analyzed using a commercially available statistical package SPSS version 20 (SPSS Inc., Chicago, Illinois, USA)  . Quantitative data were expressed as mean ± SD and were analyzed using Student's t-test. Qualitative data were expressed as number and percentage and analyzed using the χ2 -test or Fisher's exact test. The test was considered significant when P value was less than 0.05 and highly significant when P value was less than 0.001.
| Results|| |
We enrolled and randomized a total of 150 women from the beginning of February to the end of October 1 st 2014. There were no statistically significant differences between the three groups as regards age, parity, mode of delivery and lactation history, time since last delivery, and time since last menstrual period (P > 0.05) ([Table 1]).
[Table 2] shows that the mean pain recorded using VAS during speculum application in the three study groups was 3.32 ± 1.15, 3.28 ± 1.21, and 3.22 ± 1.14, respectively, with no significant difference (P > 0.05). The mean pain intensity felt during tenaculum application and cervical traction in the study groups was 4.84 ± 1.39, 4.76 ± 1.28, and 4.70 ± 1.21, respectively, with no significant difference (P > 0.05). There was no significant statistical difference between the three groups in mean pain intensity felt during IUD insertion (P > 0.05) as the mean level of VAS in the study groups was 5.30 ± 1.61, 4.90 ± 1.24, and 5.16 ± 1.20, respectively. The intensity of pain was similar in the study groups, with no significant difference after IUD insertion (P > 0.05).
|Table 2 Distribution of the studied groups as regards pain on speculum placement, tenaculum placement, intrauterine device insertion, and after procedure |
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Complications were reported in two participants who had small vaginal hematoma that resolved spontaneously with paracervical block. Five cases had dyspepsia and heart burn, three cases had headache, and three cases had vaginal spotting with NASIDs. In the control group, two cases had vaginal spotting and one case had uterine perforation that was managed conservatively. All complications resolved spontaneously with no significant difference (P > 0.05) ([Table 3]).
|Table 3 Complications reported with different analgesic methods in the three studied groups |
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| Discussion|| |
There are several factors that may contribute to the low prevalence of IUD use, such as fear of pain during insertion, and some providers avoid using IUDs in women with potential risk for pain, such as nulliparous women  .
In this randomized clinical controlled trial we enrolled a total of 150 participants for IUD insertion. We compared the effect of 1% lidocaine paracervical block with NASIDs and placebo in reducing pain that occurred during IUD insertion in the three groups. The results of our study showed no statistically significant difference as regards pain during speculum placement, tenaculum placement and cervical traction, IUD insertion, and 15 min after procedure (P > 0.05).
There were two trials that explored the effect of NSAIDs in reducing pain during IUD insertion. They were conducted by Hubacher and colleagues ,,,,,,, . Prophylactic NSAIDs, as studied, do not appear to reduce pain during IUD insertion. Moreover, the use of misoprostol to prime the cervix in addition to diclofenac before IUD insertion did not appear to reduce pain and may increase side effects .
Mody et al.  used 1% lidocaine paracervical block during IUD insertion and concluded that paracervical lidocaine did not reduce pain during IUD insertion. Moreover, there were other studies that used intrauterine lidocaine gel, such as the study by Frishman et al.  , and lidocaine spray, such as the study by Karasahin et al.  , during hysterosalpingography rather than IUD insertion and concluded that lidocaine spray may reduce pain during cervical traction in hystro -salpingiogram (HSG).
Nelson and Fong  injected 1.5 ml of lidocaine 2% into the uterine cavity through an endometrial aspirator for pain reduction during IUD insertion and concluded that 2% lidocaine administered through an endometrial aspirator did not significantly reduce IUD insertion pain scores in this pilot study.
In the study by Karasahin et al.  , 81 patients were randomly assigned to three groups to receive either 10 mg lidocaine hydrochloride 10% spray, 20 mg lidocaine hydrochloride 10% spray, or placebo. Pain was measured on VAS during cervical traction and during contrast medium injection. They concluded that topical lidocaine spray is a practical and effective method for pain reduction with HSG. A 10 mg dose is comparable to a 20 mg dose in pain reduction, with less chance of side effects and better cost-effectiveness. Different route of lidocaine application may explain the disagreement with our study.
The strength points in this study are the relatively large number of participants. Only the study by Hubacher et al.  enrolled a larger number of participants. The IUD used in this study was T 380A, which is the most popular type of IUD and the most available one in Egypt and worldwide. Analysis of pain was carried out using the standard VAS, which is the most reliable tool for assessment of pain. Moreover, being a blinded trial, there was no risk for bias either from the participant or the investigator. It is the first study to compare three types of analgesics during IUD insertion.
The limiting factor that may interfere with the results is pain threshold difference between the patients. Moreover, pain was measured 15 min after the procedure and not hourly.
Further research is needed on ways to evaluate pain management strategies for IUD fitting and study the impact of analgesics in pain reduction with IUD insertion. Given the high level of pain experienced by women who have not had a previous vaginal delivery, consideration should be given to reduce the threshold for local anesthetic use. It would be of interest to ascertain whether the way the information is given by a specific care provider could influence pain perception and reporting. Future studies should include information such as a psychological assessment of the participants in relation to expected and experienced pain.
| Conclusion|| |
Although we had hoped that 1% lidocaine paracervical block would improve pain scores among women undergoing IUD insertion, the negative findings of our study indicate the need for future research into strategies that decrease pain with IUD insertion. Minimizing discomfort at insertion will continue to reduce barriers and thus expand access to this highly effective method of contraception.
Financial support and sponsorship
Conflicts of interest
There are no conflicts of interest.
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[Table 1], [Table 2], [Table 3]