Clinical trial NCT05233683: Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
Official title: Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Anesthesia
Anesthesia, Local
Analgesia
Pediatric ALL
Pain, Postoperative
Pain, Acute
Lead sponsor: King Saud University
Sponsor class: OTHER
First posted: 2022-02-10
Enrollment: 120
Sex: MALE
Minimum age (years): 3
Maximum age (years): 4
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: All patients will receive general anesthesia. Patients will be randomly allocated to one of 4 arms of the study:

* Group 1 will receive are caudal block (CB) and circumcision with Plastibell,
* Group 2 will receive CB and circumcision with conventional dissection method (CDM),
* Group 3 will receive dorsal penile block (DPNB) and ring block (RB) and circumcision with Plastibell, and
* Group 4 will receive DPNB+ RB and circumcision with CDM.
Primary purpose: SUPPORTIVE_CARE

Brief summary: Circumcision is one of the most commonly performed operations in the pediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method (CDM). For intra-operative (OP) and post-OP pain relief, two commonly used local anesthetic techniques are caudal block (CB) and dorsal penile block (DPNB) plus ring block (RB) at the base of the penis. There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.

Detailed description: Circumcision is one of the most commonly performed operations in the paediatric population and is a painful procedure. Circumcision is performed with two popular techniques, Plastibell and conventional dissection method. Two anesthetic techniques are commonly used for intra-operative (OP) and post-OP pain relief i.e CB and DPNB+RB at the base of the penis. Addition of dexmedetomidine to bupivacaine prolongs duration of analgesia of CB. Both anaesthesia techniques of pain relief have certain advantages and disadvantages and the superiority of any technique over the other has not been established.

There are very few randomized controlled trials comparing these two methods of intra-OP and post-OP pain relief, for different surgical techniques of circumcision and there is a lack of well-conducted studies comparing the quality of analgesia, need for rescue analgesia in the early post-OP period, complications, and parental satisfaction comparing these blocks. Furthermore, there is a lot of contradiction in the literature regarding the duration of analgesia produced with these techniques.

Poorly treated postoperative pain leads to fatigue and metabolic, endocrine, and immunological changes can lead to prolonged convalescence following surgery and is traumatic to the pediatric patients and their parents. In this study, the investigators planned to compare the two most popular methods of pain relief during and after circumcision, along with parents' satisfaction.

This research will guide the anesthetists regarding the selection of appropriate techniques of intra-OP and post-OP analgesia and in light of intra and post-OP data; and parents' satisfaction.

In this prospective randomized study the investigators plan to compare the quality of intra and post OP analgesia and the duration of post-OP analgesia produced by CB and DPNB +RB, need of rescue analgesia with both of the techniques of surgery, intra-OP hemodynamic variations, residual motor block, and adverse effects and parents' satisfaction with both of the anesthesia and the surgical techniques.

Research Objectives:

To evaluate and compare the intra and post-OP pain relief under CB and DPNB plus RB in pediatric patients undergoing circumcision with different surgical techniques and assessment of parents' satisfaction

This study may guide the anesthetists for the selection of appropriate techniques of intra and post-OP analgesia and their complications for different surgical techniques of circumcision and also about parent's satisfaction with the anesthetic technique.

Eligibility criteria: Inclusion Criteria:

1. Healthy,
2. Male,
3. Ages 3 months to 4 years,
4. Scheduled for circumcision for various indications under GA.

Exclusion Criteria:

1. Patients with bleeding or clotting disorders
2. Patients with hypospadias, other penile or sacral anomalies
3. Patients weight \<3kg.
4. Allergy to Local Anesthetic
5. Infection at the site of block
6. Pre-existing spinal or neurological disease
7. Pain medication within the previous 48 hours

Primary outcomes:
measure: Efficacy of analgesia using FLACC Scale
timeFrame: First 12 hours after surgery/intervention (circumcision)
measure: Duration of analgesia
timeFrame: First 12 hours after surgery/intervention (circumcision)
Secondary outcomes:
measure: Number of participants that needed rescue analgesia
timeFrame: first 12 hours after surgery (circumcision)
measure: Motor block score
timeFrame: first 12 hours after surgery (circumcision)
measure: Blood pressure (mm/Hg)
timeFrame: during the surgery (from start time to end time of circumcision)
measure: Heart rate (beats/min)
timeFrame: during the surgery (from start time to end time of circumcision)
measure: Time to discharge from PACU
timeFrame: First 12 hours after surgery (circumcision)
measure: Number of patients with infection
timeFrame: First 5 days after surgery (circumcision)
measure: Number of patients experiencing urinary retention
timeFrame: First 12 hours after surgery (circumcision)
measure: Number of Participants with sedation
timeFrame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
measure: Number of Participants with nausea
timeFrame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
measure: Number of Participants with vomiting
timeFrame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
measure: Number of Participants with agitation
timeFrame: First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
measure: Number of Participants with penile hematoma
timeFrame: First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward
measure: Total paracetamol doses administered
timeFrame: first 5 days after surgery (circumcision)
Other outcomes:
measure: Parents' satisfaction with pain relief using Likert Scale
timeFrame: First 5 days after surgery (circumcision)
Locations:
city: Riyadh
country: Saudi Arabia
facility: King Saud University
Study officials:
affiliation: King Saud University
name: Mansoor Aqil, FCPS
role: PRINCIPAL_INVESTIGATOR
References:
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