Clinical trial NCT04840654: Pudendal vs Caudal Block for Pediatric Penile Surgery
Official title: Pudendal vs Caudal Block for Pediatric Penile Surgery
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Postoperative Pain
Keywords: Nerve Block
Caudal Block
Pudendal Block
Circumcision
Hypospadias
Postoperative Analgesia
Opioid Consumption
Pain Score
Lead sponsor: University of Chicago
Sponsor class: OTHER
First posted: 2021-04-12
Enrollment: 200
Sex: ALL
Minimum age (years): 6
Maximum age (years): 3
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Subjects will be randomized to 2 groups. One group will receive the Caudal block. The other group will receive the Pudendal block.
Primary purpose: TREATMENT

Brief summary: The study will compare recovery profile in children receiving pudendal blocks vs caudal analgesia for ambulatory circumcision or hypospadias repair in children between 6 months and 2 years. The subjects of the study will be randomized to receive either a caudal or a pudendal block.

Detailed description: The study participation will begin on the day of surgery and end at the time of last surgical follow-up visit, approximately two weeks later. All procedure related, follow-up clinic visit and PACU data will be collected by the research team from the patient's EPIC record (demographic data, pain scores in the PACU, analgesic consumption, time to perform block, time to discharge, etc). Data pertaining to the recovery of patient at home will be collected via phone call or email to the caregiver of the child. Late complications will be identified by reviewing the follow-up surgical note.

Questionnaire Administration The physical Pain journal/questionnaires

The physical Pain journal/questionnaires will be handed out to the caregiver before discharge from the Post-Anesthesia Care Unit.

The caregiver will fill out pain scores at home in the Pain Journal. The pain scores used (FLACC and PPPM) have been extensively validated. In addition, written instructions for using the pain scores to guide pain management interventions at home will be provided. Prior to discharge, caregivers will also be educated by a member of the research team on pain evaluation using the pain score and pain management algorithm.

The caregiver will be asked to answer a short questionnaire (Postoperative Parent Survey) about their child pain in the first 24 hours after discharge from the hospital. The caregiver will receive a phone call from the research team 24-48 hours after discharge to retrieve the results of the Pain Journal and Postoperative Pain Survey.

Phone Calls Approximately 24-48 hours after the child is discharged from the hospital, a member of the study team will call the caregivers/parents to retrieve the journal responses and check on the health status of the child. During this call, if there are any adverse event that may be related to the block that was performed noted, this will be documented on the AE log and a follow-up phone call will be made approximately 7 days after to verify if the event has ended or is ongoing. Upon learning about any potential related AE, the investigator will determine its severity and relationship to the study procedure and report the event per University of Chicago guidelines.

Eligibility criteria: Inclusion Criteria:

* - Children Aged 6 months -3 years
* Scheduled for elective outpatient circumcision or hypospadias repair

Exclusion Criteria:

* ASA classification ≥ 3
* emergency surgery
* history of a complex regional pain syndrome
* sacral dimple
* known vertebral spinal abnormalities, spinal dysraphism
* history of long-term analgesic use
* use of any analgesic (e.g., an opioid medication, acetaminophen, or a nonsteroidal anti-inflammatory agent) within 24 hours before surgery
* history of renal insufficiency or a bleeding disorder
* concurrent additional surgery at another anatomic site
* being a ward of the state
* a non-English speaking patient or primary caregiver
* inability of the primary caregiver to comply with home instructions

Primary outcomes:
measure: Analgesic Consumption
timeFrame: 24 Hours
Secondary outcomes:
measure: Postoperative Pain Scores
timeFrame: 2 Weeks
measure: Block failure
timeFrame: 2 Weeks
measure: Intraoperative opioid consumption
timeFrame: During Surgery
measure: Time to place the block
timeFrame: During Surgery
measure: Time to first analgesic request at home
timeFrame: 2 Weeks
Other outcomes:
Locations:
city: Chicago
country: United States
facility: University of Chicago Medical Center
state: Illinois
Study officials:
affiliation: University of Chicago
name: Leili Khorassani, MD
role: PRINCIPAL_INVESTIGATOR
References: