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

King Saud University

Status and phase: Unknown; Phase 3

Conditions: Anesthesia, Local; Pain, Acute; Pain, Postoperative; Pediatric ALL; Analgesia; Anesthesia

Treatments: Procedure: Conventional Dissection Method; Drug: Dorsal penile nerve block plus ring block; Drug: Caudal block; Procedure: Circumcision with Plastibell

Study type: Interventional

Funder types: Other

Identifiers

NCT05233683

E-21-5965

Details and patient eligibility

About

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.

Full 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.

Enrollment: 120 estimated patients

Sex: Male

Ages: 3 months to 4 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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120 participants in 4 patient groups

Caudal block and circumcision with Plastibell,

Experimental group

Description:

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.

Treatment:

Procedure: Circumcision with Plastibell

Drug: Caudal block

Caudal block and circumcision with conventional dissection method

Experimental group

Description:

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.

Treatment:

Drug: Caudal block

Procedure: Conventional Dissection Method

Dorsal penile nerve block plus ring block and circumcision with Plastibell

Active Comparator group

Description:

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using plastibell.

Treatment:

Procedure: Circumcision with Plastibell

Drug: Dorsal penile nerve block plus ring block

Dorsal penile nerve block plus ring block and circumcision with conventional dissection method

Active Comparator group

Description:

Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method

Treatment:

Procedure: Conventional Dissection Method

Drug: Dorsal penile nerve block plus ring block