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Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Pudendal Nerve Block to Penile Nerve Block

Analgesia for Pediatric Circumcision : Comparison of the Effectiveness of Neurostimulation-guided Pudendal Nerve Block to Ultrasound-guided Penile Nerve Block

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04227561
Enrollment
40
Registered
2020-01-13
Start date
2020-01-17
Completion date
2020-12-31
Last updated
2020-02-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Anesthesia, Pediatric Circumcision

Keywords

penile nerve block, pudendal nerve block

Brief summary

Medical or ritual circumcisions are frequent interventions in children. To provide the best comfort to the patients, the anesthetists use regional anesthesia. Complementary to general anesthesia, this method allows to lower the need of opioids during and after the surgery, as well as a faster recovery. The foreskin is innervated by the dorsal nerve of the penis which is the branch of the pudendal nerve. This nerve arises from the sacral plexus and more precisely the branches S2-3-4. There are two methods to block pudendal nerve. First, the pudendal nerve block is an old anesthetic technique developed in 1908, first for obstetrical analgesia and urological analgesia. It consists in injecting in the ischiorectal fossa, right at the end of Alcock's canal, a solution of local anesthetic. Second, the penile nerve block, described in the middle of the seventies, consists in injecting a solution of local anesthetic that blocks only the terminal part of the pudendal nerve. Those two nerve blocks have been subject to many publications, especially concerning the method to apply to optimize their efficiency. The literature review led to this conclusion: The penile nerve block should be ultrasound guided and the pudendal nerve block should be done with a neurostimulator. The aim of this study is to compare the analgesic efficiency of the ultra-sound guided penile nerve block to the pudendal nerve block with neurostimulation, for the pediatric circumcision.

Interventions

Pudendal nerve block will be performed under general anesthesia and guided by neurostimulation. The local anesthetic solution (chirocaine 2.5mg/ml) will be injected in the ischiorectal fossa with a needle (a BBraun Stimuplex Ultra 360 22G 50mm needle) connected to a neurostimulator (Stimuplex HNS 12 neurostimulator). The neurostimulator will be used to determine the localization of pudendal nerve and to identify the precise site of injection. The contraction of the anal sphincter or bulbocavernosus muscle occurs when the pudendal nerve is reached. These procedure will be performed bilaterally.

PROCEDUREPenile nerve block

The local anesthetic solution (chirocaine 2.5mg/ml) will be injected under the fascia of Scarpa with a real-time ultrasound guidance. These procedure will be performed bilaterally.

Sponsors

Centre Hospitalier Universitaire Saint Pierre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)

Eligibility

Sex/Gender
MALE
Age
1 Years to 2 Years
Healthy volunteers
Yes

Inclusion criteria

* One to two years old boys * Ritual or medical, elective circumcision.

Exclusion criteria

* Refusal from parents * Allergy to local anesthetics * Documented coagulation disorders * Epilepsy

Design outcomes

Primary

MeasureTime frameDescription
Time to first administration of analgesics (other than nervous blockage after induction of anesthesia)up to 24 hoursPain evaluation during surgery will be based on hemodynamic fluctuations (elevation of 15% or more of the heart rate or blood pressure) and variations of skin conductance (Med-Storm's pain monitor). In the postoperative period, the pain will be evaluated with the EVENDOL score and the variations of skin conductance

Secondary

MeasureTime frameDescription
Postoperative pain assessed with the EVENDOL scoreup to 24 hoursPain will be assessed with the EVENDOL score (score 0 to 15) at T0 (upon arrival in the recovery room), T1 (30 minutes post-surgery), T2 (1 hour post-surgery), T3 (3 hours post-surgery). EVENDOL scale is a behavioral pain scale for children aged 0 to 7 years.
Postoperative pain assessed by a pain monitor device (skin conductance algesimeter)up to 24 hoursContinuous variations of skin conductance will be measured and analyzed during the operation

Countries

Belgium

Contacts

Primary ContactPanayota Kapessidou, MD,PhD
pkapessi@ulb.ac.be+32.2.535

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026