Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques

Neuralgia Clinical Trial

Official title:

Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques: Which One is More Effective?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03973983
• Other study ID #: U1111-1234-5765
• Status: Completed
• Phase: N/A
• Start date: November 1, 2016
• Est. completion date: June 30, 2018

Study information

• Verified date: February 2024
• Source: Derince Training and Research Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Pudendal neuralgia (PN) is a painful and disabling condition, which reduces the quality of life as well. Pudendal nerve injections are essential for the diagnosis and the management of PN. The purpose of this study was to compare the effectiveness of finger-guided transvaginal pudendal nerve injection (TV-PNI) technique and the US-guided transgluteal pudendal nerve injection (TG-PNI) technique.

Description:

Pudendal neuralgia (PN) is a painful neuropathic condition for which current prevalence is unknown due to often going under-recognized by gynecologists. Pudendal neuralgia typically presents as unilateral severe sharp and burning pain, numbness, or paranesthesia on the anatomic pathways of the pudendal nerve. The most common causes for PN include pudendal nerve injury during vaginal procedures, stretching and compression of the pudendal nerve during vaginal delivery, and prolonged sitting position. 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: June 30, 2018
• Est. primary completion date: September 30, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 70 Years

Eligibility

Inclusion Criteria:

• Positive diagnostic pudendal nerve injection (PNI)

Exclusion Criteria:

• Negative diagnostic pudendal nerve injection (PNI)
• Virgin
• Sexual inactive

Related Conditions & MeSH terms

• Neuralgia
• Pudendal Nerve
• Pudendal Nerve Block

Intervention

Procedure:
• 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

Locations

Country	Name	City	State
Turkey	Hande G. Aytuluk	Kocaeli	Derince

Sponsors (1)

Lead Sponsor	Collaborator
Derince Training and Research Hospital

Country where clinical trial is conducted

Turkey, 

References & Publications (7)

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 — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pain intensity	Post-injection pain scores (while sitting, while/after intercourse and pain in the region from the anus to the clitoris) (ward) Pain scores were assessed with a 10-cm Visual Analogue Scale (VAS) (with 0 = no pain and 10 = the worst imaginable pain)	180 days
Secondary	Block success	The comparison of the success rates of both two techniques (finger guided TV-PNI vs ultrasound guided TG-PNI) Improvement of more than 50% of the initial pain VAS scores at 6 months after the PNIs completed was considered as clinical success.	180 days