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

Primary Purpose

Neuralgia, Pudendal Nerve, Pudendal Nerve Block

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)
Finger-guided transvaginal pudendal nerve injection (TV-PNI)
Sponsored by
Derince Training and Research Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neuralgia focused on measuring neuralgia, pudendal nerve, pudendal nerve block, therapeutic local anaesthesia, transvaginal

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • Positive diagnostic pudendal nerve injection (PNI)

Exclusion Criteria:

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

Sites / Locations

  • Hande G. Aytuluk

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Ultrasound-guided pudendal nerve injection group

Finger-guided pudendal nerve injection group

Arm Description

Patients who received Ultrasound-guided pudendal nerve injections

Patients who received Finger-guided pudendal nerve injections

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

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.

Full Information

First Posted
June 2, 2019
Last Updated
June 2, 2019
Sponsor
Derince Training and Research Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03973983
Brief Title
Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques
Official Title
Comparison of Ultrasound-guided Transgluteal and Finger-guided Transvaginal Pudendal Nerve Block Techniques: Which One is More Effective?
Study Type
Interventional

2. Study Status

Record Verification Date
June 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2016 (Actual)
Primary Completion Date
September 30, 2017 (Actual)
Study Completion Date
June 30, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Derince Training and Research Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
Detailed 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuralgia, Pudendal Nerve, Pudendal Nerve Block
Keywords
neuralgia, pudendal nerve, pudendal nerve block, therapeutic local anaesthesia, transvaginal

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Non-Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ultrasound-guided pudendal nerve injection group
Arm Type
Experimental
Arm Description
Patients who received Ultrasound-guided pudendal nerve injections
Arm Title
Finger-guided pudendal nerve injection group
Arm Type
Experimental
Arm Description
Patients who received Finger-guided pudendal nerve injections
Intervention Type
Procedure
Intervention Name(s)
Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)
Intervention Description
Ultrasound-guided transgluteal pudendal nerve local anesthetic injections
Intervention Type
Procedure
Intervention Name(s)
Finger-guided transvaginal pudendal nerve injection (TV-PNI)
Intervention Description
Finger-guided transvaginal pudendal nerve local anesthetic injections
Primary Outcome Measure Information:
Title
Pain intensity
Description
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)
Time Frame
180 days
Secondary Outcome Measure Information:
Title
Block success
Description
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.
Time Frame
180 days

10. Eligibility

Sex
Female
Gender Based
Yes
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Positive diagnostic pudendal nerve injection (PNI) Exclusion Criteria: Negative diagnostic pudendal nerve injection (PNI) Virgin Sexual inactive
Facility Information:
Facility Name
Hande G. Aytuluk
City
Kocaeli
State/Province
Derince
ZIP/Postal Code
41900
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
17431534
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.
Results Reference
background
PubMed Identifier
18003941
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.
Results Reference
background
PubMed Identifier
22390343
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.
Results Reference
background
PubMed Identifier
12820792
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.
Results Reference
result
PubMed Identifier
17828787
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.
Results Reference
result
PubMed Identifier
29357337
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.
Results Reference
result
PubMed Identifier
19277838
Citation
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.
Results Reference
result

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

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