About this trial
Circumcision is a widely performed surgical procedure. For this reason, optimal analgesic management is essential. Loco-regional anesthesia, particularly penile blocks, combined with general anesthesia is the technique of choice for managing analgesia during circumcisions.
Ultrasound is increasingly used in locoregional anesthesia techniques. There is already human research on penile blocks and the use of ultrasound. Studies carried out to date describe an optimization of pain relief in children after circumcision compared with the alternative technique without ultrasound, as well as a reduction in local complications due to injection. However, other studies tend to contradict these findings.
In order to provide additional knowledge and to verify whether ultrasound could provide with more optimal relief after your circumcision, the investigators are carrying out this study.
The investigators are proposing to every patient aged 0 to under 18 who is going to undergo circumcision to take part in this project. A letter is sent to all potential participants no later than 3 days before the operation. Consent can be signed no later than the day of the operation. The cooling-off period is the same regardless of age.
Taking part in the study does not affect the operation in any way. The block will take place in the operating room, prior to surgery.
In this study, participants are randomized into groups. This method is important for obtaining reliable results.
* Group 1 (intervention group): The penile block will be performed using ultrasound. * Group 2 (control group): The penile block will be performed using anatomical landmarks.
This is a "single-blind" study, which means that only the anaesthetists, investigators and operating room team will be aware of the allocation to one of the two groups.
Data on opiate consumption will be registered as well as the different durations preoperatively, intraoperatively, postoperatively, back in the recovery room and before returning home or any complications as well as pain assessment.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
male
undergoing circumcision
informed consent
Disqualifiers
other surgery than circumcision in the same time
contraindication to local anesthesia
allergy to bupivacaine
chronic opiates treatment
Trial design
Parallel
Treatments tested in this trial
Using ultrasound for penile nerve block
Procedure/Surgery30% of men over the age of fifteen worldwide have had a circumcision according to a World Health Organization report. (1) This operation is common and should not be trivialized. A certain number of surgical complications should be considered, including pain, infections, excessive bleeding or hematomas. (1,2) Today, the use of opioids as intra- and postoperative analgesics in pediatric urological surgery remains predominant (3) but is the subject of increasing controversies. Indeed, the recent opioid crisis challenges us about their use and highlights their multiple side effects. First of all, their use involves significant risks, (4) including opioid-induced hyperalgesia and potential long-term effects. An increase in pain sensitivity within the 24 postoperative hours being proportional to intraoperative administration of high doses of opioids can be observed. (5) Long-term addiction is also questioned. Then, opioids don't appear to be the most effective per- and postoperative analgesi
Dorsal Penile Block Anesthesia using landmarks
Procedure/SurgeryDorsal penile nerve block (DPNB) is LRA technique of choice for circumcisions and aims to anesthetize both dorsal penile nerves. (10-12) The name DPNB is used for blocks performed by determining precise dorsal anatomical landmarks and doing two distinct injections.
Treatment groups
Trial outcomes
Primary outcomes
Total morphine equivalent
total morphine equivalent will be cumulated and reported
Secondary outcomes
times
\- Anesthesia time, surgery time, total time in operating room, time in recovery room, time before discharge home
Adverse events
\- Incidence of adverse events of special interest (complications such as urine retention, bleeding and hematoma, nausea and vomiting).
Pain score using Face Leg Activity Cry Consolability (FLACC) or FACES or Visual Analog Scale (VAS), from 0 (no pain) to 10 (worse pain)
Maximal pain score measured and reported
Sponsors and contacts
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