Male CircumcisionNCT03914365
Pudendal Nerve Block vs Penile Nerve Block for Analgesia During Pediatric Circumcision
A study testing Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) in people with Male Circumcision and Regional Anesthesia, run by CHU de Quebec-Universite Laval at 1 site in Canada.
Trial summary
Pediatric circumcision has been realized since the beginning of human civilization. In the United States, a 2014 review revealed a 81% prevalence of men 14-59 years old being circumcised. Circumcision surgery is mostly performed on an ambulatory basis. Read more about this study
- Who is it for?
- Ages 1 year to 12 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Male Circumcision, Regional Anesthesia
- What is being tested?
- Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteCanada
- Study dates
- 1 Jul 2019to Jun 2023
- 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 1 year to 12 years
- Men only
- Healthy volunteers accepted
- Child
Who may be able to join
- Male 1-12 yo undergoing elective circumcision for medical reasons
Who cannot join
- Allergy to local anaesthetics or medication used in the study Coagulopathy Infection at the injection site Neurologic or neuromuscular disease ASA classification ≥ 4
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized Controlled Trial Comparing Ultrasound-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block for Analgesia Following Pediatric Circumcision
Pediatric circumcision has been realized since the beginning of human civilization. In the United States, a 2014 review revealed a 81% prevalence of men 14-59 years old being circumcised.
Circumcision surgery is mostly performed on an ambulatory basis. The best analgesia technique for this procedure has yet to be determined. Local, regional, general anaesthesia or even combinations have been described. The Dorsal Penile Nerve Block (DPNB) has been shown to be superior to topical analgesia in neonatal circumcision. A 2008 Cochrane review showed no difference in pain scores between caudal block and DPNB, but described more motor block with caudal block. For this reason, the 2017 Canadian Urological Association guidelines review recommends using DPNB with a ring block as a standard of care for neonatal circumcision with-out general anaesthesia. However, DPNB does not provide reliable coverage of the ventral surface of the penis and frenulum. Pudendal nerve block (PNB) is another regional anaesthesia technique gaining in popularity with the now widespread use of ultrasound guidance. However, it is still unclear if PNB can give better outcomes than DPNB. The ultrasound-guided pudendal nerve block has only been recently described and was not reviewed as an option at the time of the guidelines writing.
Read more
PNB can be performed using surface landmarks, with nerve stimulation or with ultra-sound-guidance. It has already been proven to have lower surgical complication rates than caudal block for hypospadias surgeries. Regarding DPNB, a variety of techniques have been described using either surface landmarks or ultrasound guidance. In the past ten years, two RCTs in Lebanon and Turkey compared PNB and DPNB for penile surgeries, showing lower pain scores and lower narcotics consumption in the pudendal nerve block group. None of these studies used ultrasound-guidance.
The investigators perform more than a hundred pediatric circumcisions yearly for medical indications. The surgery is done under general anaesthesia in association with either PNB or DPNB, depending on the anesthesiologist's preference. The primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain. The research team will compare peri and postoperative pain in children receiving either ultrasound-guided pudendal nerve block or ultrasound-guided dorsal penile nerve block for circumcision surgery.
Read the detailed description
All patients will receive inhalational anaesthesia induction with a mixture of oxygen/nitrous oxide and 6% sevoflurane. Nitrous oxide will be discontinued after loss of consciousness. Standard monitoring will be applied including electrocardiography, pulse oxymetry, capnography and non-invasive blood pressure monitoring. After establishing intravenous access, anaesthesia will be deepened using propofol 1 to 3 mg/kg and fentanyl 1 mcg/kg before laryngeal mask airway insertion or intubation. Neuromuscular blockade will not be administered. Maintenance of anaesthesia will be provided with sevoflurane with an end tidal sevoflurane between 1 and 1,5 MAC.
Five regional anesthesia experienced anesthesiologists not involved in the subsequent intraoperative or postoperative care of the patient will perform blocks.
Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed and sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile technique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle positioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropivacaine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side.
Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space.
The heart rate and blood pressure will be recorded before the block and every 5 minutes after block completion by the anaesthesiologist unaware of block assignment involved in the intraoperative and postoperative care of the patient. Surgical incision will be delayed for a minimum of 15 minutes after block completion. Three surgeons will perform all circumcisions using the same surgical technique. Any in-crease in blood pressure or heart rate of more than 20% above baseline within 20 minutes of block completion will be treated with an additional propofol bolus (1mg/kg) or by increasing end-tidal sevoflurane to allow for onset of the block. Any increase in blood pressure or heart rate of more than 20% above baseline 20 minutes or more after the block will be considered inadequate analgesia and will be supplemented with fentanyl 1 mcg/kg. All patients will receive dexamethasone 0,1 mg/kg (max 8 mg) and ondansetron 0,1 mg/kg (max 4 mg). Ketorolac 0,5 mg/kg (max 30 mg) will also be administered at the end of the surgery.
Pain scores using the FLACC score(16) will be recorded in the post-anesthesia care unit (PACU) and ambulatory step down unit at 5, 30, 60 and 120 minutes postoperatively by trained and blinded nurses. A pain score of 4 or higher in the PACU will lead to analgesic administration. A first dose of nalbuphine 0,1 mg/kg will be administered. If inadequate, incremental doses of morphine 0,05 mg/kg will be given until adequate analgesia is achieved. Pain will also be evaluated by parents at home using the parent postoperative pain measure (PPPM) scale at 6, 12 and 24 hours postoperatively. The parents will be instructed by a trained nurse on how to assess the child's pain using this pain measure. Patients will be prescribed acetaminophen 15 mg/kg q 4h regularly (maximum 5 doses/24 hours), ibuprofen 10 mg/kg q 8h regularly and morphine 0,1 mg/kg q 4h as needed.
- Conditions
- Male Circumcision, Regional Anesthesia
- Being tested
- Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)
- Keywords
- Circumcision, Penile block, Pudendal block, Pediatric
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)Procedure or surgery
Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain.
| Study group | Role | What they receive |
|---|---|---|
| Ultrasound-guided pudendal nerve block (PNB) | Active comparator | Standard circumcision under general anaesthesia with ultrasound-guided pudendal nerve block.Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed, sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile tech-nique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle posi-tioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropiva-caine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side. Receives: Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) |
| Ultrasound-guided penile nerve block (DPNB) | Active comparator | Standard circumcision under general anaes-thesia with ultrasound-guided penile nerve block.Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space. Receives: Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Impact of regional block on FLACC pain scores after circumcision
Impact of regional block on pain scores (FLACC score) during the 24 h post-operative period: at 5-30-60-120 minutes postoperative in hospital. The FLACC score (The Face, Legs, Activity, Cry, Consolability scale) The scale is scored in a range of 0-10 with 0 representing no pain. Will be used in the hospital at 5-30-60 and 120 minutes postop.
Measured: 24 hours
Impact of regional block on PPPM pain scores after circumcision
Impact of regional block on PPPM pain scores (parent's postoperative pain measure) during the 24 h post-operative period at 6-12-24h postop at home.
PPPM score (parents' postoperative pain measure). The scale is scored in a range of 0-15 with 0 representing no pain. Scores 6 and higher represent significant pain. Will be used at home at 6-12-and 24h postop.
Measured: 24 hours
Secondary outcomes (1)
Impact of regional block on analgesic consumption after circumcision
Impact of regional block on analgesic consumption during the first 24h post-operative period.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2019
- Study start1 Jul 2019
- Primary completionMay 2023 (estimated)
- Study completionJun 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (21)Papers the sponsor has linked to this study.
- Other trials for Male CircumcisionStudies 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
- Model description
- Randomized blinded parallel assignment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CHU de Quebec-Universite Laval
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Katherine Moore, CHU de Quebec-Universite Laval
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03914365
- Sponsor's protocol ID
- 2018-4132
- Status last verified
- Aug 2021
- First submitted
- 9 Apr 2019
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dave S, Afshar K, Braga LH, Anderson P. Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version). Can Urol Assoc J. 2018 Feb;12(2):E76-E99. doi: 10.5489/cuaj.5033. Epub 2017 Dec 1. No abstract available.
PubMed 29381458Morris BJ, Bailis SA, Wiswell TE. Circumcision rates in the United States: rising or falling? What effect might the new affirmative pediatric policy statement have? Mayo Clin Proc. 2014 May;89(5):677-86. doi: 10.1016/j.mayocp.2014.01.001. Epub 2014 Apr 2.
PubMed 24702735Sorokan ST, Finlay JC, Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee, Infectious Diseases and Immunization Committee. Newborn male circumcision. Paediatr Child Health. 2015 Aug-Sep;20(6):311-20. doi: 10.1093/pch/20.6.311.
PubMed 26435672Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004217. doi: 10.1002/14651858.CD004217.pub2.
PubMed 15495086Howard CR, Howard FM, Fortune K, Generelli P, Zolnoun D, tenHoopen C, deBlieck E. A randomized, controlled trial of a eutectic mixture of local anesthetic cream (lidocaine and prilocaine) versus penile nerve block for pain relief during circumcision. Am J Obstet Gynecol. 1999 Dec;181(6):1506-11. doi: 10.1016/s0002-9378(99)70397-2.
PubMed 10601936Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
PubMed 18843636Kendigelen 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 27501015Hecht 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 29155191Tutuncu 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 29299888Naja 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 29205687Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.
PubMed 29939703McGrath PJ, Walco GA, Turk DC, Dworkin RH, Brown MT, Davidson K, Eccleston C, Finley GA, Goldschneider K, Haverkos L, Hertz SH, Ljungman G, Palermo T, Rappaport BA, Rhodes T, Schechter N, Scott J, Sethna N, Svensson OK, Stinson J, von Baeyer CL, Walker L, Weisman S, White RE, Zajicek A, Zeltzer L; PedIMMPACT. Core outcome domains and measures for pediatric acute and chronic/recurrent pain clinical trials: PedIMMPACT recommendations. J Pain. 2008 Sep;9(9):771-83. doi: 10.1016/j.jpain.2008.04.007. Epub 2008 Jun 17.
PubMed 18562251Boric K, Jelicic Kadic A, Boric M, Zarandi-Nowroozi M, Jakus D, Cavar M, Dosenovic S, Jeric M, Batinic M, Vukovic I, Puljak L. Outcome domains and pain outcome measures in randomized controlled trials of interventions for postoperative pain in children and adolescents. Eur J Pain. 2019 Feb;23(2):389-396. doi: 10.1002/ejp.1313. Epub 2018 Sep 21.
PubMed 30179284Berde CB, Walco GA, Krane EJ, Anand KJ, Aranda JV, Craig KD, Dampier CD, Finkel JC, Grabois M, Johnston C, Lantos J, Lebel A, Maxwell LG, McGrath P, Oberlander TF, Schanberg LE, Stevens B, Taddio A, von Baeyer CL, Yaster M, Zempsky WT. Pediatric analgesic clinical trial designs, measures, and extrapolation: report of an FDA scientific workshop. Pediatrics. 2012 Feb;129(2):354-64. doi: 10.1542/peds.2010-3591. Epub 2012 Jan 16.
PubMed 22250028
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial Comparing Ultrasound-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block for Analgesia Following Pediatric Circumcision
- ClinicalTrials.gov ID
- NCT03914365
- Acronym / sponsor ID
- 2018-4132
- Conditions
- Male Circumcision, Regional Anesthesia
- Keywords
- Circumcision, Penile block, Pudendal block, Pediatric
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- CHU de Quebec-Universite LavalUniversity, hospital or other
- Study start
- 1 Jul 2019 (actual)
- Primary completion
- May 2023 (estimated)
- Study completion
- Jun 2023 (estimated)
- First posted
- 16 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.
Pediatric circumcision has been realized since the beginning of human civilization. In the United States, a 2014 review revealed a 81% prevalence of men 14-59 years old being circumcised.
Circumcision surgery is mostly performed on an ambulatory basis. The best analgesia technique for this procedure has yet to be determined. Local, regional, general anaesthesia or even combinations have been described. The Dorsal Penile Nerve Block (DPNB) has been shown to be superior to topical analgesia in neonatal circumcision. A 2008 Cochrane review showed no difference in pain scores between caudal block and DPNB, but described more motor block with caudal block. For this reason, the 2017 Canadian Urological Association guidelines review recommends using DPNB with a ring block as a standard of care for neonatal circumcision with-out general anaesthesia. However, DPNB does not provide reliable coverage of the ventral surface of the penis and frenulum. Pudendal nerve block (PNB) is another regional anaesthesia technique gaining in popularity with the now widespread use of ultrasound guidance. However, it is still unclear if PNB can give better outcomes than DPNB. The ultrasound-guided pudendal nerve block has only been recently described and was not reviewed as an option at the time of the guidelines writing.
PNB can be performed using surface landmarks, with nerve stimulation or with ultra-sound-guidance. It has already been proven to have lower surgical complication rates than caudal block for hypospadias surgeries. Regarding DPNB, a variety of techniques have been described using either surface landmarks or ultrasound guidance. In the past ten years, two RCTs in Lebanon and Turkey compared PNB and DPNB for penile surgeries, showing lower pain scores and lower narcotics consumption in the pudendal nerve block group. None of these studies used ultrasound-guidance.
The investigators perform more than a hundred pediatric circumcisions yearly for medical indications. The surgery is done under general anaesthesia in association with either PNB or DPNB, depending on the anesthesiologist's preference. The primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain. The research team will compare peri and postoperative pain in children receiving either ultrasound-guided pudendal nerve block or ultrasound-guided dorsal penile nerve block for circumcision surgery.
Detailed description
All patients will receive inhalational anaesthesia induction with a mixture of oxygen/nitrous oxide and 6% sevoflurane. Nitrous oxide will be discontinued after loss of consciousness. Standard monitoring will be applied including electrocardiography, pulse oxymetry, capnography and non-invasive blood pressure monitoring. After establishing intravenous access, anaesthesia will be deepened using propofol 1 to 3 mg/kg and fentanyl 1 mcg/kg before laryngeal mask airway insertion or intubation. Neuromuscular blockade will not be administered. Maintenance of anaesthesia will be provided with sevoflurane with an end tidal sevoflurane between 1 and 1,5 MAC.
Five regional anesthesia experienced anesthesiologists not involved in the subsequent intraoperative or postoperative care of the patient will perform blocks.
Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed and sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile technique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle positioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropivacaine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side.
Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space.
The heart rate and blood pressure will be recorded before the block and every 5 minutes after block completion by the anaesthesiologist unaware of block assignment involved in the intraoperative and postoperative care of the patient. Surgical incision will be delayed for a minimum of 15 minutes after block completion. Three surgeons will perform all circumcisions using the same surgical technique. Any in-crease in blood pressure or heart rate of more than 20% above baseline within 20 minutes of block completion will be treated with an additional propofol bolus (1mg/kg) or by increasing end-tidal sevoflurane to allow for onset of the block. Any increase in blood pressure or heart rate of more than 20% above baseline 20 minutes or more after the block will be considered inadequate analgesia and will be supplemented with fentanyl 1 mcg/kg. All patients will receive dexamethasone 0,1 mg/kg (max 8 mg) and ondansetron 0,1 mg/kg (max 4 mg). Ketorolac 0,5 mg/kg (max 30 mg) will also be administered at the end of the surgery.
Pain scores using the FLACC score(16) will be recorded in the post-anesthesia care unit (PACU) and ambulatory step down unit at 5, 30, 60 and 120 minutes postoperatively by trained and blinded nurses. A pain score of 4 or higher in the PACU will lead to analgesic administration. A first dose of nalbuphine 0,1 mg/kg will be administered. If inadequate, incremental doses of morphine 0,05 mg/kg will be given until adequate analgesia is achieved. Pain will also be evaluated by parents at home using the parent postoperative pain measure (PPPM) scale at 6, 12 and 24 hours postoperatively. The parents will be instructed by a trained nurse on how to assess the child's pain using this pain measure. Patients will be prescribed acetaminophen 15 mg/kg q 4h regularly (maximum 5 doses/24 hours), ibuprofen 10 mg/kg q 8h regularly and morphine 0,1 mg/kg q 4h as needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized blinded parallel assignment
| Arm | Type | Receives |
|---|---|---|
| Ultrasound-guided pudendal nerve block (PNB) | Active comparator | Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)Standard circumcision under general anaesthesia with ultrasound-guided pudendal nerve block.Pudendal nerve block patients will be positioned dorsally with the legs in the " frog " position (hips in abduction, knees flexed, sole of the feet together). An ultrasound-guided technique will be used as described previously. A linear probe will be positioned horizontally between the ischiatic tuberosity and the rectum. The ischiorectal fossa is then located between these two landmarks. Using a sterile tech-nique, an echogenic 22 gauge, 50 mm block needle will be inserted out of plane on the superior edge of the probe, midline between the ischiatic tuberosity and the rectum. After feeling two distinct fascial " clics " and confirmation of correct needle posi-tioning in the ischiorectal fossa under ultrasound, 0,2 mL/kg (max 10mL) of ropiva-caine 0,25% will be injected under real-time ultrasound-guidance after negative aspiration. The same technique will be repeated on the contralateral side. |
| Ultrasound-guided penile nerve block (DPNB) | Active comparator | Procedure: Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)Standard circumcision under general anaes-thesia with ultrasound-guided penile nerve block.Penile nerve block patients will be positioned in the supine position. An ultrasound-guided technique will be used as described previously. A linear probe will be placed transversely at the base of the penis while an assistant applies caudal traction to the penis. The penile neurovascular sheath is then located just above the corpus cavernosum. The dorsal penile nerve, dorsal penile artery and penile deep dorsal vein are visualized deep to Buck's fascia. Using a sterile technique, a 25 gauge, 1,5 inch needle will be inserted in-plane from lateral to medial so that the needle tip is placed into the penile neurovascular sheath, 0,1 mL/kg (max 4 mL) of ropivacaine 0,25% will be injected under real-time ultrasound guidance while retracting the needle so that the local anaesthetic solution spreads bilaterally filling the neurovascular space. |
Who may qualify
- Ages
- 1 year to 12 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- Male 1-12 yo undergoing elective circumcision for medical reasons
Key exclusion criteria (1 listed)
- Allergy to local anaesthetics or medication used in the study Coagulopathy Infection at the injection site Neurologic or neuromuscular disease ASA classification ≥ 4
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 |
|---|---|---|
| Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB)Our primary objective is to compare analgesia between the two blocks during and after pediatric circumcisions to minimize post-operative pain. | Procedure or surgery | Ultrasound-guided penile nerve block (DPNB), Ultrasound-guided pudendal nerve block (PNB) |
Primary outcome
Impact of regional block on FLACC pain scores after circumcision
Time frame: 24 hours
Impact of regional block on pain scores (FLACC score) during the 24 h post-operative period: at 5-30-60-120 minutes postoperative in hospital. The FLACC score (The Face, Legs, Activity, Cry, Consolability scale) The scale is scored in a range of 0-10 with 0 representing no pain. Will be used in the hospital at 5-30-60 and 120 minutes postop.
Impact of regional block on PPPM pain scores after circumcision
Time frame: 24 hours
Impact of regional block on PPPM pain scores (parent's postoperative pain measure) during the 24 h post-operative period at 6-12-24h postop at home. PPPM score (parents' postoperative pain measure). The scale is scored in a range of 0-15 with 0 representing no pain. Scores 6 and higher represent significant pain. Will be used at home at 6-12-and 24h postop.
1 secondary outcome
Impact of regional block on analgesic consumption after circumcision
Time frame: 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Background: PubMed 29381458Dave S, Afshar K, Braga LH, Anderson P. Canadian Urological Association guideline on the care of the normal foreskin and neonatal circumcision in Canadian infants (full version). Can Urol Assoc J. 2018 Feb;12(2):E76-E99. doi: 10.5489/cuaj.5033. Epub 2017 Dec 1. No abstract available.
- Background: PubMed 24702735Morris BJ, Bailis SA, Wiswell TE. Circumcision rates in the United States: rising or falling? What effect might the new affirmative pediatric policy statement have? Mayo Clin Proc. 2014 May;89(5):677-86. doi: 10.1016/j.mayocp.2014.01.001. Epub 2014 Apr 2.
- Background: PubMed 26435672Sorokan ST, Finlay JC, Jefferies AL; Canadian Paediatric Society, Fetus and Newborn Committee, Infectious Diseases and Immunization Committee. Newborn male circumcision. Paediatr Child Health. 2015 Aug-Sep;20(6):311-20. doi: 10.1093/pch/20.6.311.
- Background: PubMed 15495086Brady-Fryer B, Wiebe N, Lander JA. Pain relief for neonatal circumcision. Cochrane Database Syst Rev. 2004 Oct 18;2004(4):CD004217. doi: 10.1002/14651858.CD004217.pub2.
- Background: PubMed 10601936Howard CR, Howard FM, Fortune K, Generelli P, Zolnoun D, tenHoopen C, deBlieck E. A randomized, controlled trial of a eutectic mixture of local anesthetic cream (lidocaine and prilocaine) versus penile nerve block for pain relief during circumcision. Am J Obstet Gynecol. 1999 Dec;181(6):1506-11. doi: 10.1016/s0002-9378(99)70397-2.
- Background: PubMed 18843636Cyna AM, Middleton P. Caudal epidural block versus other methods of postoperative pain relief for circumcision in boys. Cochrane Database Syst Rev. 2008 Oct 8;2008(4):CD003005. doi: 10.1002/14651858.CD003005.pub2.
- 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 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.
- 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 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 29939703Suleman MI, Akbar Ali AN, Kanarek V, Li M, Patel A. Ultrasound Guided In-Plane Penile Nerve Block for Circumcision: A New, Modified Technique Suggests Lower Anesthetic Volume and Narcotic Use. Middle East J Anaesthesiol. 2016 Oct;23(6):647-53.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Ultrasound-guided pudendal nerve block (PNB) and Ultrasound-guided penile nerve block (DPNB) in people with Male Circumcision and Regional Anesthesia, run by CHU de Quebec-Universite Laval at 1 site in Canada.
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 1 inclusion and 1 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 5 Aug 2021. 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 Canada. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Impact of regional block on FLACC pain scores after circumcision (time frame: 24 hours). The study lists 2 primary outcomes in all. 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 NCT03914365, which also lists 21 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 5 Aug 2021.