Evaluating the Effectiveness of Pharmacological Strategies and Further Measures for Pain Relief during Hysterosonosalpingography: A Systematic Review
Abstract
:1. Introduction
2. Materials and Methods
2.1. Search Strategy
2.2. Study Design
2.3. Inclusion Criteria
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- Population: Women undergoing HyCoSy or SIS for the assessment of tubal patency.
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- Intervention: Pharmacological strategies and measures to prevent procedure related pain
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- Comparator: Placebo or no intervention.
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- Timing: Before or during HyCoSy or SIS.
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- Outcome: Pain perception.
2.4. Study Selection and Data Extraction
2.5. Aim of the Systematic Review
2.6. Ethical Approval
2.7. Data Synthesis and Analysis
2.8. Risk of Bias
3. Results
3.1. Study Selection
3.2. Included Studies
- Type of patients:
Author and Year | Study Design, Country and Time of Realization | Participants, Main Inclusion Criteria | Interventions | Catheter | Groups | Pain Perception | Outcomes |
---|---|---|---|---|---|---|---|
Moro F et al., 2012 [21] | RCT double-blind ------- Rome, Italy ------- January 2003-March 2010 | 856 infertile patients ----- -20–41 years ----- -Infertile for less than 3 years ----- Exclusion criteria: Hypersensitivity to hyoshine-N-butylbromide -AUB -acute sexual transmitted disease or pelvic inflammatory disease -severe male factor -known or suspected pregnancy -treatment with OCP | hysterosalpingo-contrast sonography (HyCoSy) ----- 30 min before 10 mg hyoscine- N-butylbromide tablet or placebo tablet | Foley catheter 6 Fr in diameter was inserted into the uterine cavity and the balloon of the catheter was inflated with 1.5–2 mL sterile saline ----- Air and saline solution were instilled (15 mL of each) | 856 patients (n = 40 excluded) --- 408 Yoscine group and 408 placebo group | Stacey score (0–4) Operator asked after the procedure any pain experienced, comparing with pain suffered during menstrual cycle | -No difference in pain score -Differences in pain scoring according to fallopian tubal patency |
Fenzl V., 2012 [22] | Prospective and randomized study ------- Croatia ------- Ignote period | 138 patients ------- Infertile patients evaluated at the hospital ----- no exclusion criteria | First hypoechogenic (0.9% saline) following hyperechogenic (Echovist) contrasts at room (25 °C) or body temperature (37 °C) ----- All received 1 h before a tablet of 50 mg diclofenac | Foley catheter size eight was inserted in the istmic part of the uterine cavity; the balloon was filled with 1.5 mL sterile water | 138 patients ------- n = 68 patients (25 °C) and n = 70 patients (37 °C) | VAS scores (0–10) immediately after the procedure | -Significant difference in pain during introduction of the same contrast at different temperature(p < 0.001) --- Echovist induces significantly less pain than saline infusion |
Jareethum R et al., 2010 [23] | Double blind randomized controlled trial ------ Bangkok, Thailand ------- March 2009-December 2009 | 141 patients ------- -nulliparous women, -age over 18 years -never had HSG or hysteroscopy ----- Exclusion criteria: -sexually transmitted disease or pelvic inflammatory disease -abnormal pap smear -hypersensitivity to mefenamic or hyoscine | Saline infusion sonohysterography --- 30 min before procedure 2 tablets (=500 mg) of mefenamic acid, or 1 tablet of 10 mg of hyoscine or 1 or 2 tablets of a placebo | A non-balloon catheter with 6.6 Fr outer diameter ----- Normal saline (200 mL) | 141 infertile patients(excluded 0) In 6 cases intervention failed --- Mefenamic group n = 46, Hyoscine group n = 47 and placebo group n = 48 | VAS (0–10) -before starting -after catheter insertion -maximum pain during SIS -immediately after -30 min after | No statistically significant differences were found in baseline characteristics, pain and satisfaction scores |
Guney M. et al., 2007 [15] | Double blind randomized controlled trial ------- Turkey --- September 2004- April 2006 | 120 patients ------- Unspecified inclusion criteria ------ Exclusion criteria: -pregnancy, -acute cervicitis, -or profuse vaginal bleeding. | Saline solution infusion sonohysterography (SIS) ----- 2%lidocaine 5 mL or saline solution 5 mL into the uterine cavity before SIS | A sterile balloon catheter was placed in the endocervix and inflated with 1 mL of sterile water (5–10 mL) | 120 enrolled patients (n = 14 excluded) ----- 106 patients: Study group (n = 53), Placebo group (n = 53) | VAS pain scores (0–10)-and patients distress recorded by the physician during, immediately after and 20 min after | -Intrauterine lidocaine reduced pain in parous |
Spieldoch R.L. et al., 2008 [18] | Prospective randomized clinical study ------- Wisconsin --- December 2004-August 2005 | 69 women ------- Exclusion criteria -previous hysterectomy -current pregnancy -active PID -patulous or stenotic cervical os | Saline solution infusion sonohysterography (SIS) ----- All patients took NSAIDs 1 h before procedure ----- Cervical or intrauterine balloon catheter | 2 lumen 5 French balloon catheter distended with 1 mL | 69 enrolled patients ----- n = 35 cervical catheter, n = 34 uterine catheter | VAS pain scores (0–10)at the time balloon was inflated and after deflation | -Nulliparous women had significantly more pain than did parous -they have less pain in the cervical placement upon inflation and similar upon deflation |
Melcer Y. et al., 2021 [16] | Randomized double-blind placebo-controlled trial ----- Israel ----- June 2020- September 2020 | 85 infertile women ----- Exclusion criteria -allergic to lidocaine, -unprotected intercourse, -chronic pelvic pain, -profuse vaginal bleeding, -reported inflammation or infections of the genital tract -psychological or neurological lesions affecting sensation, -a history of cervical surgery, or cervical stenosis | Saline and foam gel consecutively sonohysterography 2D-3D ----- intrauterine infusion of 10 mL 2% lidocaine or 10 mL 0.9% normal saline solution before the procedure | balloon-less GIS catheter (GynaecologIQ, Delft, the Netherlands) with a soft tapered tip was inserted into the endocervical canal | 85 women (n = 5 excluded) ----- n = 40 lidocaine group and n = 40 placebo group | VAS (0–10) before the procedure and pain during the phase of intrauterine foam instillation on the VAS scale while seated in the waiting area | VAS during the procedure indicated that lidocaine flushing was associated with significantly less pain than ratings in the saline group. In the nulliparous and multiparous lidocaine group of patients, significant pain relief was obtained by the use of lidocaine |
Amhadi F et al., 2019 [24] | Randomized double blind 2-armed clinical trial ----- Iran ----- May 2012- May 2014 | 300 infertile women ----- 18–45 yo ----- Exclusion criteria: -acute pelvic infection -severe endometriosis -AUB -history of patulous or stenotic cervical os -large benign tumors or the cavity | Saline infusion sonohysterography ----- Cervical or intrauterine catheter balloon placement ----- No medications | 6F balloon catheter into the cervical canal (mid cervix) or inside the uterine cavity; inflated with 1.2 mL of a sterile saline solution (10–30 mL). | 348 women (n = 48 excluded) ----- n = 150 intrauterine balloon and n = 150 intracervical catheter | 10 points visual analog scale at 2 periods: at time of inflation and after deflation | No statistical differences between the groups |
Yung SSF et al., 2016 [20] | Randomized, double blind, placebo controlled trial ----- Hong Kong ----- February–June 2015 | 120 women ----- Aged 18 or over ----- Exclusion criteria: -history of cervical stenosis -Allergy to lidocaine -Pregnancy -acute cervicitis -profuse vaginal Bleeding | Saline contrast sonohysterography ----- Prior the procedure: -3 mL 2% lidocaine gel applied to the cervix and intrauterine infusion of 5 mL normal saline (lidocaine gel group) -3 mL gel lubricant applied to the cervix and intrauterine infusion of 5 mL 2% lidocaine (lidocaine infusion group) -3 mL gel lubricant | 8-Fr infant feeding tube inserted into the uterine cavity | 150 patients (n = 30 declined to participate) ----- n = 40 lidocaine gel group n = 40 lidocaine infusion group n = 40 placebo group | Pain score from 0 to 100 before, during and 20 min after the procedure | Topical lidocaine gel application and intrauterine lidocaine infusion do not further reduce pain levels |
Ozkan S et al., 2016 [19] | Randomized controlled trial ----- Turkey ------ March 2011–August 2011 | 120 women ------ 23–62 yo ----- Exclusion criteria: -severe systemic medical conditions, -cervical stenosis, -acute cervicitis and/or vaginitis, -lidocaine allergy | Saline infusion sonography ----- Patients received -2 mL 2% lidocaine into the cervix at 4- and 8 o’clock positions at a depth of 2–3 cm paracervical block (group 2), or -an 18-gauge intravenous catheter into the cervical canal up to the internal os. Two milliliters of 2% lidocaine was injected into the uterine cavity paracervical block +intrauterine lidocaine (group 3), or -only saline (controls, group 1) Tenaculum was applied 5 min after All patients were prescribed 500 mg azithromycin as prophylaxis | number 4 carmen cannula was inserted in the uterine cavity. The uterine cavity was filled with 50 mL of normal saline solution | 120 patients(n = 24 excluded) ----- 96 patients: -n = 32 saline (controls, group 1), -n = 32 paracervical block (group 2), or -n = 32 paracervical block +intrauterine lidocaine (group 3) | VAS scores (0–10). to grade discomfort experienced | -statistically differences between the saline and paracervical block groups, and between the saline and paracervical block + intrauterine lidocaine group. -no statistically significant difference between paracervical block and paracervical block + intrauterine lidocaine groups |
Nirmal D. et al., 2006 [17] | RCT study double blinded ----- Cardiff, UK ----- unknown period | 149 women ----- primary or secondary infertility ----- Exclusion criteria: -if laparoscopy was more appropriate -previous pelvic inflammatory disease -history suggestive of endometriosis -adnexal pathology | hysterosalpingo-contrast sonography (HyCoSy) ----- (Echovist) contrasts at room (25 °C) or body temperature (37 °C) | 5 French gauge catheter via cervical canal was inserted into the uterine cavity with a small balloon at the tip of the catheter | 149 patients ------- n = 77 patients (25 °C) and n = 72 patients (37 °C) | Stacey score (0–4) Operator asked after the procedure any pain experienced, comparing with pain suffered during menstrual cycle | -Significant reduction of pain perception when Echovist was warmed at 37 °C (p = 0.006) |
- Type of procedure: Three studies evaluated the tubal patency [17,21,22], while the others were conducted to control the uterine cavity. Melcer et al. studied tubal patency and endometrial cavity too. A preliminary pelvic examination was performed digitally [19,22], with B-mode transvaginal ultrasound [16,18,20,21] or with 3D transvaginal ultrasound [24], while two studies did not report any baseline examination [15,23]. Amhadi et al. and Yung et al. used a 3D ultrasound for evaluating intrauterine abnormalities, Ozkan et al. used a 4D examination.
- Type of catheter: A wide heterogeneity in the catheter type and position characterizes these studies. Six studies utilized a balloon catheter, placed in the uterine cavity [21,22], in the cervix [15,16], or both [18,24]. Moreover, the catheter used measured 6 Fr in two studies [21,24], 5 Fr in Spieldoch et al. study, 8 Fr in Fenzl et al. study. Guney et al. and Melcer et al. did not state the catheter diameter. The balloon was filled with 1 mL of saline [15,18], 1.5–2 mL [21], 1.5 mL [22], 1.2 mL [24], and no information was given in the Melcer et al. study [16]. Four studies were conducted using a non-catheter balloon placed on the uterine cavity with different diameter: 6.6 Fr [23], 6 Fr [20], 5 Fr [17], 4 carmen [19].
- Type of contrast medium: Six studies were performed using the saline infusion with different total volume: In the work of Jareethum et al., 200 mL was infused to each patient, Guney et al. used 5–10 mL, Amhadi et al. introduced 10–30 mL of saline solution; in the other three studies, the information was missing [16,18,20]. Moro et al. instilled air and saline solution (15 mL for each patient); Fenzl et al. used saline solution following positive contrast Echovist at maximum 10 mL of saline and 15 mL of Echovist. They also considered the temperature of the contrast media as at room (25 °C) or body temperature (37 °C). Melcer used normal saline or lidocaine followed by foam gel. Nirmal et al. used Echovist.
- Other technical details: The procedures were performed during the follicular phase: late follicular phase [21], early follicular phase [24], before the 14th day [16] between 6th and 11th day [22], 6th and 10th [23], and on 8th and 9th days [20]. We cannot find any specification on timing exams in the studies of Guney et al., Nirmal et al. and Okzan et al. Fenzl et al. and Spieldoch et al. declared the patients had taken non-steroidal anti-inflammatory drugs1 h before the procedure. The mean time period of the complete procedure was considered only in the Moro et al. study. The tenaculum grasped the cervix in all patients of the Ozkan et al. study.
- Type of intervention: Five studies compared the use of painkillers with the placebo [15,19,20,21,23], two studies compared different catheter positions in the cervix or in the uterine cavity [18,24]. Fenzl et al. and Nirmal et al. considered different temperatures of the contrast medium as a method to reduce pain. Moro et al. administered 10 mg of hyoscine-N-butylbromide tablet 30 min before the procedures. Jareethum et al. utilized 30 min before the exam 10 mg of hyoscine-N-butylbromide tablet or 500 mg of mefenamic acid. Four studies used lidocaine: Guney et al. provided lidocaine 2% in 5 mL into the uterine cavity prior the exam, Melcer et al. used 10 mL lidocaine 2% in the cavity before the foam injection, Yung et al. utilized lidocaine gel 2% applied to the cervix or lidocaine 2% in 5 mL into the uterine cavity, and Okzan et al. used paracervical block with or without lidocaine 2% in 2 mL into the uterine cavity.
4. Discussion
5. Conclusions
Supplementary Materials
Author Contributions
Funding
Institutional Review Board Statement
Informed Consent Statement
Data Availability Statement
Conflicts of Interest
References
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Riva, A.; Vitagliano, A.; Noventa, M.; Buzzaccarini, G.; Damiani, G.R.; Vimercati, A.; Morano, D.; Taliento, C.; Greco, P.; Cicinelli, E.; et al. Evaluating the Effectiveness of Pharmacological Strategies and Further Measures for Pain Relief during Hysterosonosalpingography: A Systematic Review. Diagnostics 2022, 12, 3185. https://doi.org/10.3390/diagnostics12123185
Riva A, Vitagliano A, Noventa M, Buzzaccarini G, Damiani GR, Vimercati A, Morano D, Taliento C, Greco P, Cicinelli E, et al. Evaluating the Effectiveness of Pharmacological Strategies and Further Measures for Pain Relief during Hysterosonosalpingography: A Systematic Review. Diagnostics. 2022; 12(12):3185. https://doi.org/10.3390/diagnostics12123185
Chicago/Turabian StyleRiva, Arianna, Amerigo Vitagliano, Marco Noventa, Giovanni Buzzaccarini, Gianluca Raffaello Damiani, Antonella Vimercati, Danila Morano, Cristina Taliento, Pantaleo Greco, Ettore Cicinelli, and et al. 2022. "Evaluating the Effectiveness of Pharmacological Strategies and Further Measures for Pain Relief during Hysterosonosalpingography: A Systematic Review" Diagnostics 12, no. 12: 3185. https://doi.org/10.3390/diagnostics12123185