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 :
Condition or disease | Intervention/treatment | Phase |
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Phimosis | Procedure: Pudendal nerve block | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Care Provider, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children: A Randomized Clinical Trial |
Actual Study Start Date : | April 30, 2019 |
Estimated Primary Completion Date : | July 10, 2020 |
Estimated Study Completion Date : | July 10, 2020 |
Arm | Intervention/treatment |
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Experimental: Dual guidance (ultrasound and neurostimulation)
This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation)
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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.
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Active Comparator: ultrasound-guided only
This arm : patients will be received pudendal nerve block by ultrasound-guided only.
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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.
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Postoperative analgesics including
use Face Legs Activity Cry Consolability scale patients will be assessed by FLACCs , 6 times
FLACC score (score 1-10, minimum is 1, maximum is 10) FLACC score >3 , patients will be received fentanyl 0.5 micrograms/kilogram
incidence of :
Ages Eligible for Study: | 8 Months to 7 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Exclusion Criteria:
Contact: Witchaya Supaopaspan, medical | 66891992599 | widjy14@hotmail.com | |
Contact: Artid Samerchua, medical | 66826944496 | artidsamerchua@gmail.com |
Thailand | |
Ramathibodi Hospital | Recruiting |
Bangkok, Ratchathewi, Thailand, 10400 | |
Contact: Witchaya Supaopaspan, medical 022011513 widjy14@hotmail.com | |
Contact: Sawapat Phongdara, medical 0624690999 |
Principal Investigator: | Witchaya Supaopaspan, medical | Ramathibodi Hospital | |
Study Director: | Artid Samerchua, medical | Maharaj Nakorn Chiang Mai Hospital |
Tracking Information | |||||||||
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First Submitted Date ICMJE | April 23, 2019 | ||||||||
First Posted Date ICMJE | April 30, 2019 | ||||||||
Last Update Posted Date | March 11, 2020 | ||||||||
Actual Study Start Date ICMJE | April 30, 2019 | ||||||||
Estimated Primary Completion Date | July 10, 2020 (Final data collection date for primary outcome measure) | ||||||||
Current Primary Outcome Measures ICMJE |
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
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Original Primary Outcome Measures ICMJE | Same as current | ||||||||
Change History | |||||||||
Current Secondary Outcome Measures ICMJE |
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Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
Current Other Pre-specified Outcome Measures | Not Provided | ||||||||
Original Other Pre-specified Outcome Measures | Not Provided | ||||||||
Descriptive Information | |||||||||
Brief Title ICMJE | Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children | ||||||||
Official Title ICMJE | Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children: A Randomized Clinical Trial | ||||||||
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 :
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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. |
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Study Type ICMJE | Interventional | ||||||||
Study Phase ICMJE | Not Applicable | ||||||||
Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Triple (Participant, Care Provider, Outcomes Assessor) Primary Purpose: Treatment |
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Condition ICMJE | Phimosis | ||||||||
Intervention ICMJE | 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.
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Study Arms ICMJE |
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Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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Recruitment Information | |||||||||
Recruitment Status ICMJE | Recruiting | ||||||||
Estimated Enrollment ICMJE |
40 | ||||||||
Original Estimated Enrollment ICMJE | Same as current | ||||||||
Estimated Study Completion Date ICMJE | July 10, 2020 | ||||||||
Estimated Primary Completion Date | July 10, 2020 (Final data collection date for primary outcome measure) | ||||||||
Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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Sex/Gender ICMJE |
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Ages ICMJE | 8 Months to 7 Years (Child) | ||||||||
Accepts Healthy Volunteers ICMJE | Yes | ||||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Thailand | ||||||||
Removed Location Countries | |||||||||
Administrative Information | |||||||||
NCT Number ICMJE | NCT03931850 | ||||||||
Other Study ID Numbers ICMJE | 12-61-49 | ||||||||
Has Data Monitoring Committee | Yes | ||||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Witchaya Supaopaspan, Ramathibodi Hospital | ||||||||
Study Sponsor ICMJE | Ramathibodi Hospital | ||||||||
Collaborators ICMJE | Maharaj Nakorn Chiang Mai Hospital | ||||||||
Investigators ICMJE |
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PRS Account | Ramathibodi Hospital | ||||||||
Verification Date | March 2020 | ||||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |