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

Primary Purpose

Phimosis

Status
Unknown status
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
Pudendal nerve block
Sponsored by
Ramathibodi Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Phimosis focused on measuring Pudendal nerve, circumcision, pediatric

Eligibility Criteria

8 Months - 7 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Ramathibodi HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Dual guidance (ultrasound and neurostimulation)

ultrasound-guided only

Arm Description

This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation)

This arm : patients will be received pudendal nerve block by ultrasound-guided only.

Outcomes

Primary Outcome Measures

the proportion of patients who need opioids in recovery room
the proportion of patients who need opioids in recovery room in each group

Secondary Outcome Measures

Block success rate
No increasing of blood pressure or heart rate more than 10 % of baseline before incision
Postoperative analgesic requirement in 24 hours
Postoperative analgesics including Fentanyl : unit is microgram paracetamol : milligrams
Time to first analgesic medication
Time (in hours) that patients received the first analgesic medications.
Pain score will be assessed by Face Legs Activity Cry Consolability scale (FLACCs)
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
Parents' Postoperative Pain Measure-Short Form (PPPM-SF)
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
Performance time
Time spent for performing pudendal nerve block ( minutes)
Complications from pudendal nerve block
incidence of : vaacular puncture rectal puncture internal organ injury local anesthetic toxicity voiding difficulty
Parental satisfaction score
Parental satisfaction score : scoring from 1-5 ( 1 = unsatisfied, 5=the most satisfied)

Full Information

First Posted
April 23, 2019
Last Updated
March 9, 2020
Sponsor
Ramathibodi Hospital
Collaborators
Maharaj Nakorn Chiang Mai Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03931850
Brief Title
Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children
Official Title
Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children: A Randomized Clinical Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2020
Overall Recruitment Status
Unknown status
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
July 10, 2020 (Anticipated)
Study Completion Date
July 10, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Ramathibodi Hospital
Collaborators
Maharaj Nakorn Chiang Mai Hospital

4. Oversight

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

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Phimosis
Keywords
Pudendal nerve, circumcision, pediatric

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Dual guidance (ultrasound and neurostimulation)
Arm Type
Experimental
Arm Description
This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation)
Arm Title
ultrasound-guided only
Arm Type
Active Comparator
Arm Description
This arm : patients will be received pudendal nerve block by ultrasound-guided only.
Intervention Type
Procedure
Intervention Name(s)
Pudendal nerve block
Intervention Description
Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.
Primary Outcome Measure Information:
Title
the proportion of patients who need opioids in recovery room
Description
the proportion of patients who need opioids in recovery room in each group
Time Frame
1 hour (in recovery room)
Secondary Outcome Measure Information:
Title
Block success rate
Description
No increasing of blood pressure or heart rate more than 10 % of baseline before incision
Time Frame
Intraoperation
Title
Postoperative analgesic requirement in 24 hours
Description
Postoperative analgesics including Fentanyl : unit is microgram paracetamol : milligrams
Time Frame
24 hours postoperation
Title
Time to first analgesic medication
Description
Time (in hours) that patients received the first analgesic medications.
Time Frame
24 hours after operation
Title
Pain score will be assessed by Face Legs Activity Cry Consolability scale (FLACCs)
Description
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
Time Frame
6 hours after arriving the ward
Title
Parents' Postoperative Pain Measure-Short Form (PPPM-SF)
Description
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
Time Frame
6 hours after arriving the ward untill 24 hours after operation
Title
Performance time
Description
Time spent for performing pudendal nerve block ( minutes)
Time Frame
Intraoperation
Title
Complications from pudendal nerve block
Description
incidence of : vaacular puncture rectal puncture internal organ injury local anesthetic toxicity voiding difficulty
Time Frame
24 hours after operation
Title
Parental satisfaction score
Description
Parental satisfaction score : scoring from 1-5 ( 1 = unsatisfied, 5=the most satisfied)
Time Frame
24 hours after operation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Months
Maximum Age & Unit of Time
7 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Witchaya Supaopaspan, medical
Phone
66891992599
Email
widjy14@hotmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Artid Samerchua, medical
Phone
66826944496
Email
artidsamerchua@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Witchaya Supaopaspan, medical
Organizational Affiliation
Ramathibodi Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Artid Samerchua, medical
Organizational Affiliation
Maharaj Nakorn Chiang Mai Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Ramathibodi Hospital
City
Bangkok
State/Province
Ratchathewi
ZIP/Postal Code
10400
Country
Thailand
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Witchaya Supaopaspan, medical
Phone
022011513
Email
widjy14@hotmail.com
First Name & Middle Initial & Last Name & Degree
Sawapat Phongdara, medical
Phone
0624690999

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
6625133
Citation
Yeoman PM, Cooke R, Hain WR. Penile block for circumcision? A comparison with caudal blockade. Anaesthesia. 1983 Sep;38(9):862-6. doi: 10.1111/j.1365-2044.1983.tb12251.x.
Results Reference
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3976329
Citation
Vater M, Wandless J. Caudal or dorsal nerve block? A comparison of two local anaesthetic techniques for postoperative analgesia following day case circumcision. Acta Anaesthesiol Scand. 1985 Feb;29(2):175-9. doi: 10.1111/j.1399-6576.1985.tb02180.x.
Results Reference
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PubMed Identifier
3885795
Citation
Tree-Trakarn T, Pirayavaraporn S. Postoperative pain relief for circumcision in children: comparison among morphine, nerve block, and topical analgesia. Anesthesiology. 1985 Apr;62(4):519-22. doi: 10.1097/00000542-198504000-00027. No abstract available.
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Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children

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