PhimosisNCT03931850
Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children
A study testing Pudendal nerve block in people with Phimosis, run by Ramathibodi Hospital at 1 site in Thailand.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 months to 7 yearsHealthy volunteers can take part
- Conditions the study is for
- Phimosis
- What is being tested?
- Pudendal nerve block
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteThailand
- Study dates
- 30 Apr 2019to 10 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 months to 7 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Thailand1 site, 1 recruiting
- Recruiting
Ramathibodi Hospital
Bangkok, Ratchathewi, 10400
Witchaya Supaopaspan, medical, 022011513, widjy14@hotmail.com
Sawapat Phongdara, medical, 0624690999
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Phimosis
- Being tested
- Pudendal nerve block
- Keywords
- Pudendal nerve, circumcision, pediatric
- Medical subject headings
- Phimosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pudendal nerve blockProcedure or surgery
Pudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area.
| Study group | Role | What they receive |
|---|---|---|
| Dual guidance (ultrasound and neurostimulation) | Experimental | This arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation) Receives: Procedure: Pudendal nerve block |
| ultrasound-guided only | Active comparator | This arm : patients will be received pudendal nerve block by ultrasound-guided only. Receives: Procedure: Pudendal nerve block |
What is being measured
The primary outcome is the main question the study is designed to answer.
the proportion of patients who need opioids in recovery room
the proportion of patients who need opioids in recovery room in each group
Measured: 1 hour (in recovery room)
Secondary outcomes (8)
Block success rate
No increasing of blood pressure or heart rate more than 10 % of baseline before incision
Measured: Intraoperation
Postoperative analgesic requirement in 24 hours
Postoperative analgesics including
- Fentanyl : unit is microgram
- paracetamol : milligrams
Measured: 24 hours postoperation
Time to first analgesic medication
Time (in hours) that patients received the first analgesic medications.
Measured: 24 hours after operation
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
Measured: 6 hours after arriving the ward
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
Measured: 6 hours after arriving the ward untill 24 hours after operation
Performance time
Time spent for performing pudendal nerve block ( minutes)
Measured: Intraoperation
Complications from pudendal nerve block
incidence of :
- vaacular puncture
- rectal puncture
- internal organ injury
- local anesthetic toxicity
- voiding difficulty
Measured: 24 hours after operation
Parental satisfaction score
Parental satisfaction score : scoring from 1-5 ( 1 = unsatisfied, 5=the most satisfied)
Measured: 24 hours after operation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2019
- Study start30 Apr 2019
- Primary completion10 Jul 2020 (estimated)
- Study completion10 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (16)Papers the sponsor has linked to this study.
- Other trials for PhimosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ramathibodi Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Maharaj Nakorn Chiang Mai Hospital
- Responsible party
- Principal investigator, Witchaya Supaopaspan, Ramathibodi Hospital
- Investigators
- Witchaya Supaopaspan, medical, Principal investigator, Ramathibodi HospitalArtid Samerchua, medical, Study director, Maharaj Nakorn Chiang Mai Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03931850
- Sponsor's protocol ID
- 12-61-49
- Status last verified
- Mar 2020
- First submitted
- 23 Apr 2019
- Last updated
- 11 Mar 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 6625133Vater 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.
PubMed 3976329Tree-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.
PubMed 3885795Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
PubMed 30074928Ivani G, Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, Krane E, Veyckemans F, Polaner DM, Van de Velde M, Neal JM. The European Society of Regional Anaesthesia and Pain Therapy and the American Society of Regional Anesthesia and Pain Medicine Joint Committee Practice Advisory on Controversial Topics in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):526-32. doi: 10.1097/AAP.0000000000000280.
PubMed 26192549Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
PubMed 29319604Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.
PubMed 29299888Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
PubMed 27501015Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.
PubMed 24257391Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
PubMed 21790518Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.
PubMed 29205687Hecht S, Pineda J, Bayne A. Ultrasound-guided Pudendal Block Is a Viable Alternative to Caudal Block for Hypospadias Surgery: A Single-Surgeon Pilot Study. Urology. 2018 Mar;113:192-196. doi: 10.1016/j.urology.2017.11.006. Epub 2017 Nov 16.
PubMed 29155191Mamlouk MD, vanSonnenberg E, Dehkharghani S. CT-guided nerve block for pudendal neuralgia: diagnostic and therapeutic implications. AJR Am J Roentgenol. 2014 Jul;203(1):196-200. doi: 10.2214/AJR.13.11346.
PubMed 24951215Naja Z, Ziade MF, Lonnqvist PA. Nerve stimulator guided pudendal nerve block decreases posthemorrhoidectomy pain. Can J Anaesth. 2005 Jan;52(1):62-8. doi: 10.1007/BF03018582.
PubMed 15625258Naja Z, El-Rajab M, Al-Tannir M, Ziade F, Zbibo R, Oweidat M, Lonnqvist PA. Nerve stimulator guided pudendal nerve block versus general anesthesia for hemorrhoidectomy. Can J Anaesth. 2006 Jun;53(6):579-85. doi: 10.1007/BF03021848.
PubMed 16738292
Study at a glance
From the registry record, last updated by the sponsor on 11 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Does Neurostimulation Improve Efficacy for Ultrasound-Guided Transperineal Pudendal Nerve Block In Children: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT03931850
- Acronym / sponsor ID
- 12-61-49
- Conditions
- Phimosis
- Keywords
- Pudendal nerve, circumcision, pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Ramathibodi HospitalUniversity, hospital or other
- Collaborators
- Maharaj Nakorn Chiang Mai Hospital
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 10 Jul 2020 (estimated)
- Study completion
- 10 Jul 2020 (estimated)
- First posted
- 30 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dual guidance (ultrasound and neurostimulation) | Experimental | Procedure: Pudendal nerve blockThis arm : patients will be received pudendal nerve block by dual guidance technique ( ultrasound and neurostimulation) |
| ultrasound-guided only | Active comparator | Procedure: Pudendal nerve blockThis arm : patients will be received pudendal nerve block by ultrasound-guided only. |
Who may qualify
- Ages
- 8 months to 7 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pudendal nerve blockPudendal nerve block is the one of peripheral nerve block. Injection local anesthetic medication around this nerve can provide analgesia around perineal area. | Procedure or surgery | Dual guidance (ultrasound and neurostimulation), ultrasound-guided only |
Primary outcome
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
8 secondary outcomes
Block success rate
Time frame: Intraoperation
Postoperative analgesic requirement in 24 hours
Time frame: 24 hours postoperation
Time to first analgesic medication
Time frame: 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
Parents' Postoperative Pain Measure-Short Form (PPPM-SF)
Time frame: 6 hours after arriving the ward untill 24 hours after operation
Performance time
Time frame: Intraoperation
Complications from pudendal nerve block
Time frame: 24 hours after operation
Parental satisfaction score
Time frame: 24 hours after operation
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2020.
- Background: PubMed 6625133Yeoman 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.
- Background: PubMed 3976329Vater 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.
- Background: PubMed 3885795Tree-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.
- Background: PubMed 30074928Walker BJ, Long JB, Sathyamoorthy M, Birstler J, Wolf C, Bosenberg AT, Flack SH, Krane EJ, Sethna NF, Suresh S, Taenzer AH, Polaner DM, Martin L, Anderson C, Sunder R, Adams T, Martin L, Pankovich M, Sawardekar A, Birmingham P, Marcelino R, Ramarmurthi RJ, Szmuk P, Ungar GK, Lozano S, Boretsky K, Jain R, Matuszczak M, Petersen TR, Dillow J, Power R, Nguyen K, Lee BH, Chan L, Pineda J, Hutchins J, Mendoza K, Spisak K, Shah A, DelPizzo K, Dong N, Yalamanchili V, Venable C, Williams CA, Chaudahari R, Ohkawa S, Usljebrka H, Bhalla T, Vanzillotta PP, Apiliogullari S, Franklin AD, Ando A, Pestieau SR, Wright C, Rosenbloom J, Anderson T; Pediatric Regional Anesthesia Network Investigators. Complications in Pediatric Regional Anesthesia: An Analysis of More than 100,000 Blocks from the Pediatric Regional Anesthesia Network. Anesthesiology. 2018 Oct;129(4):721-732. doi: 10.1097/ALN.0000000000002372.
- Background: PubMed 26192549Ivani G, Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, Krane E, Veyckemans F, Polaner DM, Van de Velde M, Neal JM. The European Society of Regional Anaesthesia and Pain Therapy and the American Society of Regional Anesthesia and Pain Medicine Joint Committee Practice Advisory on Controversial Topics in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2015 Sep-Oct;40(5):526-32. doi: 10.1097/AAP.0000000000000280.
- Background: PubMed 29319604Suresh S, Ecoffey C, Bosenberg A, Lonnqvist PA, de Oliveira GS Jr, de Leon Casasola O, de Andres J, Ivani G. The European Society of Regional Anaesthesia and Pain Therapy/American Society of Regional Anesthesia and Pain Medicine Recommendations on Local Anesthetics and Adjuvants Dosage in Pediatric Regional Anesthesia. Reg Anesth Pain Med. 2018 Feb;43(2):211-216. doi: 10.1097/AAP.0000000000000702.
- Background: PubMed 29299888Tutuncu AC, Kendigelen P, Ashyyeralyeva G, Altintas F, Emre S, Ozcan R, Kaya G. Pudendal Nerve Block Versus Penile Nerve Block in Children Undergoing Circumcision. Urol J. 2018 May 3;15(3):109-115. doi: 10.22037/uj.v0i0.4292.
- Background: PubMed 27501015Kendigelen P, Tutuncu AC, Emre S, Altindas F, Kaya G. Pudendal Versus Caudal Block in Children Undergoing Hypospadias Surgery: A Randomized Controlled Trial. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):610-5. doi: 10.1097/AAP.0000000000000447.
- Background: PubMed 24257391Naja ZM, Ziade FM, Kamel R, El-Kayali S, Daoud N, El-Rajab MA. The effectiveness of pudendal nerve block versus caudal block anesthesia for hypospadias in children. Anesth Analg. 2013 Dec;117(6):1401-7. doi: 10.1213/ANE.0b013e3182a8ee52.
- Background: PubMed 21790518Naja Z, Al-Tannir MA, Faysal W, Daoud N, Ziade F, El-Rajab M. A comparison of pudendal block vs dorsal penile nerve block for circumcision in children: a randomised controlled trial. Anaesthesia. 2011 Sep;66(9):802-7. doi: 10.1111/j.1365-2044.2011.06753.x. Epub 2011 Jul 25.
- Background: PubMed 29205687Gaudet-Ferrand I, De La Arena P, Bringuier S, Raux O, Hertz L, Kalfa N, Sola C, Dadure C. Ultrasound-guided pudendal nerve block in children: A new technique of ultrasound-guided transperineal approach. Paediatr Anaesth. 2018 Jan;28(1):53-58. doi: 10.1111/pan.13286. Epub 2017 Dec 5.
- Background: PubMed 29155191Hecht S, Pineda J, Bayne A. Ultrasound-guided Pudendal Block Is a Viable Alternative to Caudal Block for Hypospadias Surgery: A Single-Surgeon Pilot Study. Urology. 2018 Mar;113:192-196. doi: 10.1016/j.urology.2017.11.006. Epub 2017 Nov 16.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Witchaya Supaopaspan, medical principal investigator
Ramathibodi Hospital
Artid Samerchua, medical study director
Maharaj Nakorn Chiang Mai Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pudendal nerve block in people with Phimosis, run by Ramathibodi Hospital at 1 site in Thailand.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 11 Mar 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Witchaya Supaopaspan, medical (66891992599, widjy14@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the proportion of patients who need opioids in recovery room (time frame: 1 hour (in recovery room)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03931850, which also lists 16 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Mar 2020; AzTrials last refreshed its copy on 7 Nov 2026.