Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children

March 9, 2020 updated by: Witchaya Supaopaspan, Ramathibodi Hospital

Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children: A Randomized Clinical Trial

This study aim to compare efficacy of transperineal pudendal nerve block between 2 techniques, by dual guidance (ultrasound and neurostimulation) vs by ultrasound-guided only, in pediatric patients who undergo circumcision.

Primary outcome : Block efficacy will be assessed from ratio of patients who receive opioids in immediate postoperative period.

Secondary outcomes :

  • This study also measure other aspects of pain which can reflect the block efficacy including pain score in 24 hours, postoperative analgesic requirement in 24 hours, time to first analgesia, block success rate.
  • Block performance : imaging time, needling time, total performance time,
  • Block safety : collect complications from block including vascular/rectal puncture, bleeding (hematoma), local anesthetic systemic toxicity, voiding difficulty
  • Parental satisfaction will be also collected which scoring use 1-5 metric.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Pain after circumcision is moderate to high level. Inadequate pain control leads to severe agitation, swelling of the wound, neurobehavioral change, lower parental satisfaction. Pain control for circumcision including topical, Dorsal penile nerve block, Caudal block. Topical is inadequate to control post-circumcision pain. Dorsal penile nerve block is not completely cover every areas of penis and also has 4-6.7% failure rate. For Caudal block provides good pain control but it is not proper for ambulatory surgery because of common adverse effects such as motor weakness, urinary retension, moreover it has short duration only 6 hours after block.

In the last 15 years, large-scale studies from many countries studied the safety of regional anesthesia in pediatric patients. It was found that the central neuraxial and peripheral nerve blockage can be done safely, especially using ultrasound-guided to increase safety. Therefore, regional anesthesia is extensive performed in pediatric patients with the main purpose of controlling postoperative pain after surgery, reducing the use of opioids analgesics which may cause respiratory depression, especially in young children.Pudendal nerve block for postoperative pain relief for circumcision, hypospadias has been shown to be effective.

Pudendal nerve derives from anterior rami of spinal nerve root S2-S4 then runs into Alcock's canal and enters the ischiorectal fossa. In this area, pudendal nerve will separate to 3 branches 1) Dorsal penile nerve 2) Perineal branch 3) Rectal branch, therefore pudendal nerve block can provide effective postoperative pain control for surgery around perineal area such as circumcision, hypospadias, anoplasty.

There were several studies on the effectiveness of pudendal nerve block for treating pudendal neuralgia and to control pain after hemorrhoidectomy in adult patients. For pediatric patients, the effectiveness of pudendal nerve block in circumcision surgery compared to the dorsal nerve block was found that in the group receiving the pudendal nerve block, the pain score is lower, with less painkiller and longer pain control. In addition, the study of the pudendal nerve block in pediatric patients who underwent hypospadias in comparison to caudal block, the group that received the pudendal nerve block had a longer duration of pain relief.It can be concluded that the pudendal nerve block is more effective in pain control than the traditional dorsal penile nerve block for circumcision and more effective than caudal block for hypospadias. In addition, it can avoid side effects from caudal block, such as motor weakness, urinary retension, and can be a good alternative pain relief for patients who have contraindication to neuraxial block.

However, the effectiveness of pain control by the pudendal nerve block method is also different, which may be the technical difference of the block. In principle, for the performing peripheral nerve block, the more injection of local anesthetics approach the nerve, the more efficacy will also be followed, and the duration of action will be longer. But the injection near the nerve will increase the chance of causing nerve damage.Therefore, the ideal method of the peripheral nerve block is to inject as close to the nerve as possible without causing injury to the nerves, which is currently a device that can be used to identify the position of the nerve. 1) Using Nerve Stimulator (NS), stimulator by looking at the response of muscles when electrically stimulated, the position used to identify the proximity of the needles to the nerve is the response of the muscle at 0.5 milliampere and no response when using electricity 0.2 milliampere,which indicates that the needle tip is in the right position, not too close or too far 2) Using an ultrasound-guided, which allows to see the position of nerves, blood vessels, and adjacent organs, which can be injected at the point without harm. 3) Using dual-guidance (both ultrasound together with nerve stimulator, which is expected to benefit both of these methods.

The study conducted by Naja and Kendigelen supported that the use of the Nerve Stimulator-guided could provide 100% success rate with patients requiring extra painkillers within the first 24 hours only 7.5-20%. The performance time of block is 2-8 minutes. Later, the study by Gaudet-Ferrand that performed pudendal nerve block under U/S-guided only in pediatric patients who underwent perineum surgery, they reported the success rate only 88% and 60% of patients required opioids in recovery room. Which , compared to previous studies, there was no patient who wanted opioid in recovery room.That show the use of U/S guided pudendal nerve block only is less effective than performing by Nerve Stimulator-guided, which possible cause is U/S could not identify pudendal nerve in every patients.That makes the injection too far from nerve or can injure the nerve unintentionally.

However, using only the Nerve Stimulator still has a risk of injury to important organs such as rectum or adjacent vessels, especially in small children or performing by less expertise. So using U/S will increase safety of block.

This study will find out the effectiveness of performing transperineal pudendal nerve block by dual guidance which use both of NS and U/S guided compare with using U/S guided only. Assuming that the dual guidance technique should increase the effectiveness of the pudendal nerve block compare to the use of U/S guided alone. The primary outcome is the efficacy of postoperative pain control by evaluating the proportion of patients who need opioids during immediate postoperative period.

Study Type

Interventional

Enrollment (Anticipated)

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 Contact

Study Contact Backup

Study Locations

  • Thailand
    • Ratchathewi
      • Bangkok, Ratchathewi, Thailand, 10400
        • Recruiting
        • Ramathibodi hospital
        • Contact:
        • Contact:
          • Sawapat Phongdara, medical
          • Phone Number: 0624690999

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

8 months to 7 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Age between 8 months to 7 years
  • American Society of Anesthesiologists (ASA) class 1-3
  • Undergoing elective circumcision
  • Consent to participate in research by the parents signing the letter of intent to participate in the research project

Exclusion Criteria:

  • Refuse to receive regional nerve block
  • Allergic to Bupivacaine or Paracetamol
  • Coagulopathy
  • Severe coexisting liver or kidney disease
  • There is a wound or infection in the pelvis area
  • Underlying neurodeficit including attention deficit, cerebral palsy, Down's syndrome
  • Parents cannot evaluate pain scores
  • Patients or parents have willing to withdraw from research.

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dual guidance (ultrasound and neurostimulation)
This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation)
Procedure: Pudendal nerve block
Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.
Active Comparator: ultrasound-guided only
This arm : patients will be received pudendal nerve block by ultrasound-guided only.
Procedure: Pudendal nerve block
Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
the proportion of patients who need opioids in recovery room
Time Frame: 1 hour (in recovery room)
the proportion of patients who need opioids in recovery room in each group
1 hour (in recovery room)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Block success rate
Time Frame: Intraoperation
No increasing of blood pressure or heart rate more than 10 % of baseline before incision
Intraoperation
Postoperative analgesic requirement in 24 hours
Time Frame: 24 hours postoperation

Postoperative analgesics including

  1. Fentanyl : unit is microgram
  2. paracetamol : milligrams
24 hours postoperation
Time to first analgesic medication
Time Frame: 24 hours after operation
Time (in hours) that patients received the first analgesic medications.
24 hours after operation
Pain score will be assessed by Face Legs Activity Cry Consolability scale (FLACCs)
Time Frame: 6 hours after arriving the ward

use Face Legs Activity Cry Consolability scale patients will be assessed by FLACCs , 6 times

  • In recovery room : will assess every 15 minutes, 4 times
  • Time at Arriving the ward
  • 6 hours after arriving the ward

FLACC score (score 1-10, minimum is 1, maximum is 10) FLACC score >3 , patients will be received fentanyl 0.5 micrograms/kilogram
6 hours after arriving the ward
Parents' Postoperative Pain Measure-Short Form (PPPM-SF)
Time Frame: 6 hours after arriving the ward untill 24 hours after operation
Patients will be assessed by PPPM-SF by parents every 6 hours PPPM-SF (score 1-10, minimum is 1, maximum is 10) score > 1 , patients will be received paracetamol 15 milligrams/ kilogram
6 hours after arriving the ward untill 24 hours after operation
Performance time
Time Frame: Intraoperation
Time spent for performing pudendal nerve block ( minutes)
Intraoperation
Complications from pudendal nerve block
Time Frame: 24 hours after operation

incidence of :

  • vaacular puncture
  • rectal puncture
  • internal organ injury
  • local anesthetic toxicity
  • voiding difficulty
24 hours after operation
Parental satisfaction score
Time Frame: 24 hours after operation
Parental satisfaction score : scoring from 1-5 ( 1 = unsatisfied, 5=the most satisfied)
24 hours after operation

Collaborators and Investigators

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

Sponsor

Ramathibodi Hospital

Collaborators

Maharaj Nakorn Chiang Mai Hospital

Investigators

  • Principal Investigator: Witchaya Supaopaspan, medical, Ramathibodi hospital
  • Study Director: Artid Samerchua, medical, Maharaj Nakorn Chiang Mai 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)

April 30, 2019

Primary Completion (Anticipated)

July 10, 2020

Study Completion (Anticipated)

July 10, 2020

Study Registration Dates

First Submitted

April 23, 2019

First Submitted That Met QC Criteria

April 29, 2019

First Posted (Actual)

April 30, 2019

Study Record Updates

Last Update Posted (Actual)

March 11, 2020

Last Update Submitted That Met QC Criteria

March 9, 2020

Last Verified

March 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 12-61-49

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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