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

February 16, 2024 updated by: Hande Gurbuz, Derince Training and Research Hospital

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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).

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Derince
      • Kocaeli, Derince, Turkey, 41900
        • Hande G. Aytuluk

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Positive diagnostic pudendal nerve injection (PNI)

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Ultrasound-guided pudendal nerve injection group
Patients who received Ultrasound-guided pudendal nerve injections
Procedure: Ultrasound-guided transgluteal pudendal nerve injection (TG-PNI)
Ultrasound-guided transgluteal pudendal nerve local anesthetic injections
Experimental: Finger-guided pudendal nerve injection group
Patients who received Finger-guided pudendal nerve injections
Procedure: Finger-guided transvaginal pudendal nerve injection (TV-PNI)
Finger-guided transvaginal pudendal nerve local anesthetic injections

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pain intensity
Time Frame: 180 days
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block success
Time Frame: 180 days
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Derince Training and Research Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2016

Primary Completion (Actual)

September 30, 2017

Study Completion (Actual)

June 30, 2018

Study Registration Dates

First Submitted

June 2, 2019

First Submitted That Met QC Criteria

June 2, 2019

First Posted (Actual)

June 4, 2019

Study Record Updates

Last Update Posted (Actual)

February 20, 2024

Last Update Submitted That Met QC Criteria

February 16, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • U1111-1234-5765

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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