Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques
NCT ID: NCT03973983
Last Updated: 2024-02-20
Study Results
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Basic Information
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COMPLETED
NA
40 participants
INTERVENTIONAL
2016-11-01
2018-06-30
Brief Summary
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Detailed Description
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As in many neuropathic syndromes, there is currently no gold standard diagnostic test for assessing PN. In 2006, the Nantes criteria were described by a multidisciplinary working party to describe the clinical diagnostic criteria, and a standard approach was created for PN diagnosis. According to the Nantes criteria, patients should fulfil all five essential criteria without meeting any of the exclusion criteria. The five essential diagnostic criteria were defined as, 1: pain in the anatomic territory of the pudendal nerve, 2: that is worsened by sitting, 3: the patient is not woken at night by the pain, 4: no objective sensory loss on clinical examination, and 5: positive anesthetic pudendal nerve block.
Pudendal nerve infiltration (PNI), which was defined as an essential step, is performed for diagnostic purposes and as an important treatment modality in patients with PN. This approach aims for long-term relief of pain, as in all forms of nerve entrapment syndromes, by treating a possible inflammatory component, it also provides neuroprotection to the central nervous system and reduces spontaneous ectopic activity of the affected nerve.
Image-guided or finger-guided PNIs can be performed according to the experience of the physician, adequate equipment presence, and patient choice. The pudendal nerve is situated in the deepest area in the pelvis and it makes the PNI technically difficult if transperineal or transgluteal approaches are preferred. For this reason, it usually requires imaging guidance to target the injection site such as ultrasound, computed tomography, fluoroscopy, and magnetic resonance.
Ultrasound-guided transgluteal (TG) PNI has been described to reach the pudendal nerve in the plane between the sacrotuberous and sacrospinous ligaments. This technique has many advantages such as visualization of the substantial structures (pudendal artery and the sciatic nerve) without radiation exposure it enables real-time images. However, finger-guided transvaginal (TV) PNI should be kept in mind as a PNI option with the advantages of familiarity for gynecologists and obstetricians as an essential part of obstetric anesthesia. Finger-guided blocks in women are easily performed via a vaginal approach by palpation the ischial spines and the injection is targeted slightly medially and posteriorly to the ischial spines.
Over the past 20 years, studies have described the PNI techniques, but a limited number of studies have compared the efficacy of image-guided PNI techniques. To the best of our knowledge, there are no studies comparing the finger-guided TV-PNI and US-guided TG-PNI for the evaluation of pain relief in patients with PN. We hypothesized that the finger-guided TV technique is effective as US-guided TG-PNI when performed to relieve pain in patients with PN. The primary outcome of the present study was to evaluate the changes of mean VAS scores based on the mean daily maximum pain intensity score during the week before day 0 (D0), day 7 (D7), day 21 (D21), and day 180 (D180). Secondly, the post-block complication rate was evaluated in overall blocks. Secondary outcome included the comparison of the success rates of both two techniques (from D0 to D180).
Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Ultrasound-guided pudendal nerve injection group
Patients who received Ultrasound-guided pudendal nerve injections
Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)
Ultrasound-guided transgluteal pudendal nerve local anesthetic injections
Finger-guided pudendal nerve injection group
Patients who received Finger-guided pudendal nerve injections
Finger-guided transvaginal pudendal nerve injection (TV-PNI)
Finger-guided transvaginal pudendal nerve local anesthetic injections
Interventions
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Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)
Ultrasound-guided transgluteal pudendal nerve local anesthetic injections
Finger-guided transvaginal pudendal nerve injection (TV-PNI)
Finger-guided transvaginal pudendal nerve local anesthetic injections
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Virgin
* Sexual inactive
18 Years
70 Years
FEMALE
No
Sponsors
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Derince Training and Research Hospital
OTHER
Responsible Party
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Hande Gurbuz
Principal Investigator
Locations
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Hande G. Aytuluk
Kocaeli, Derince, Turkey (Türkiye)
Countries
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References
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Roth TM. Management of persistent groin pain after transobturator slings. Int Urogynecol J Pelvic Floor Dysfunct. 2007 Nov;18(11):1371-3. doi: 10.1007/s00192-007-0365-1. Epub 2007 Apr 13.
Treede RD, Jensen TS, Campbell JN, Cruccu G, Dostrovsky JO, Griffin JW, Hansson P, Hughes R, Nurmikko T, Serra J. Neuropathic pain: redefinition and a grading system for clinical and research purposes. Neurology. 2008 Apr 29;70(18):1630-5. doi: 10.1212/01.wnl.0000282763.29778.59. Epub 2007 Nov 14.
Vancaillie T, Eggermont J, Armstrong G, Jarvis S, Liu J, Beg N. Response to pudendal nerve block in women with pudendal neuralgia. Pain Med. 2012 Apr;13(4):596-603. doi: 10.1111/j.1526-4637.2012.01343.x. Epub 2012 Mar 5.
Ramsden CE, McDaniel MC, Harmon RL, Renney KM, Faure A. Pudendal nerve entrapment as source of intractable perineal pain. Am J Phys Med Rehabil. 2003 Jun;82(6):479-84.
Labat JJ, Riant T, Robert R, Amarenco G, Lefaucheur JP, Rigaud J. Diagnostic criteria for pudendal neuralgia by pudendal nerve entrapment (Nantes criteria). Neurourol Urodyn. 2008;27(4):306-10. doi: 10.1002/nau.20505.
Kastler A, Puget J, Tiberghien F, Pellat JM, Krainik A, Kastler B. Dual Site Pudendal Nerve Infiltration: More than Just a Diagnostic Test? Pain Physician. 2018 Jan;21(1):83-90.
Fanucci E, Manenti G, Ursone A, Fusco N, Mylonakou I, D'Urso S, Simonetti G. Role of interventional radiology in pudendal neuralgia: a description of techniques and review of the literature. Radiol Med. 2009 Apr;114(3):425-36. doi: 10.1007/s11547-009-0371-0. Epub 2009 Mar 10. English, Italian.
Other Identifiers
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U1111-1234-5765
Identifier Type: -
Identifier Source: org_study_id
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