Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children

Phase 3

• Conditions: Anesthesia; Anesthesia, Local; Analgesia; Pediatric ALL; Pain, Postoperative; Pain, Acute
• Interventions: Drug: Caudal block; Drug: Dorsal penile nerve block plus ring block; Procedure: Circumcision with Plastibell; Procedure: Conventional Dissection Method

• Registration Number: NCT05233683
• Lead Sponsor: King Saud University

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.

Study Timeline

• Study First Submitted: 2021-10-22
• Status Verified: 2022-01
• Study First Submitted QC: 2022-01-31
• Last Update Submitted: 2022-01-31
• Study First Posted: 2022-02-10
• Last Update Posted: 2022-02-10
• Study Start: 2022-03
• Primary Completion: 2023-03
• Study Completion: 2023-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Caudal block and circumcision with Plastibell,	Caudal block	Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Caudal block and circumcision with Plastibell,	Circumcision with Plastibell	Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using plastibell. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Caudal block and circumcision with conventional dissection method	Caudal block	Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Caudal block and circumcision with conventional dissection method	Conventional Dissection Method	Caudal block will be performed with 0.75ml/kg of 0.25% bupivacaine containing 1 mic/kg dexmedetomidine. Circumcision will be done using the conventional dissection method. Paracetamol suppository will also be inserted per rectum in the dose of 15 mg/kg before the start of surgery. The surgery will be started 10 minutes after block placement to allow adequate time for the block to be effective.
Dorsal penile nerve block plus ring block and circumcision with Plastibell	Dorsal penile nerve block plus ring block	Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.
Dorsal penile nerve block plus ring block and circumcision with Plastibell	Circumcision with Plastibell	Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.
Dorsal penile nerve block plus ring block and circumcision with conventional dissection method	Dorsal penile nerve block plus ring block	Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method
Dorsal penile nerve block plus ring block and circumcision with conventional dissection method	Conventional Dissection Method	Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method

Primary Outcome Measures

Name	Time	Method
Duration of analgesia	First 12 hours after surgery/intervention (circumcision)	To compare the duration of post-OP analgesia produced by CB and DPNB plus RB in children undergoing circumcision with two different surgical techniques.
Efficacy of analgesia using FLACC Scale	First 12 hours after surgery/intervention (circumcision)	Postoperatively in the PACU, the child will be observed in the recovery room by a senior nurse blinded to the anesthetic technique and the FLACC score will be used for pain assessment (copy attached). The FLACC scale is a uni-dimensional behavioral pain assessment instrument to measure pain in young children in the post-OP period. It includes five items (Face, Leg, Activity, Cry, and Consolability) and has good inter-rater reliability (Kappa 0.52-0.82), as well as good content and convergent validity. The scale is scored in a range of 0-10 with 0 = no pain and 10 = severe pain. The FLACC is reliable in critically ill young children. The severity of pain will be classified using the total score 0=no pain, and 10= severe pain. I.V fentanyl will be administered in the dose of 0.5 mic/kg if the pain score is \>5 and the dose will be repeated if the FLACC score persisted \>5 after five minutes.

Secondary Outcome Measures

Name	Time	Method
Time to discharge from PACU	First 12 hours after surgery (circumcision)	Amount of time the patient stays in PACU after the surgery. This will be a continuous variable (time).
Number of participants that needed rescue analgesia	first 12 hours after surgery (circumcision)	Number of participants that needed rescue analgesia in PACU and ward
Motor block score	first 12 hours after surgery (circumcision)	Motor block score will be recorded (0=spontaneous movements of hips, knees and ankles, 1=movements of knees and ankles but no movements of hips, 2=only movements of ankles, and 3=no movements of lower limbs).
Number of patients with infection	First 5 days after surgery (circumcision)	Number of patients experiencing infection at site of circumcision. It will be recorded as yes/no.
Number of patients experiencing urinary retention	First 12 hours after surgery (circumcision)	Measured as: no urine output after intervention.
Blood pressure (mm/Hg)	during the surgery (from start time to end time of circumcision)	Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Heart rate (beats/min)	during the surgery (from start time to end time of circumcision)	Patients will receive fentanyl 0.5 mic/kg, if at any stage HR or BP increased 25% more than baseline value and the total dose of rescue analgesia received intra-operatively will be recorded.
Number of Participants with sedation	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward	Sedation will be measured using the The Pasero Opioid-Induced Sedation Scale (POSS). POSS is a standardized approach to assessing opioid-induced sedation and instituting interventions. The POSS scores are S ("sleep, easy to arouse"), 1 ("awake and alert"), 2 ("slightly drowsy, easily aroused"), 3 ("frequently drowsy, arousable, drifts off to sleep during conversation"), and 4 ("somnolent, minimal, or no response to verbal or physical stimulation"). Scores of S, 1, or 2 are considered acceptable; the opioid dose may be increased if needed.
Number of Participants with nausea	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward	Will be recorded as yes/no
Number of Participants with vomiting	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward	Will be recorded as yes/no
Number of Participants with agitation	First 12 hours after surgery: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward	Will be recorded as yes/no
Number of Participants with penile hematoma	First 12 hours after surgery/intervention: assessed at 5, 15, and 30 minutes in PACU and hourly in the ward	Will be recorded as yes/no
Total paracetamol doses administered	first 5 days after surgery (circumcision)	Amount of paracetamol required by the patient for pain control

Trial Locations

Locations (1)

King Saud University; 🇸🇦 Riyadh, Saudi Arabia