| Registry | NCT05233683 |
|---|---|
| Status | Unknown |
| Phase | Phase 3 |
| Study type | Interventional; randomized, parallel, masking: double, supportive care |
| Enrollment | 120 (Estimated) |
| Sponsor | King Saud University (Other) |
| Conditions | Anesthesia, Anesthesia, Local, Analgesia, Pediatric ALL, Pain, Postoperative, Pain, Acute |
| Interventions | Caudal block, Dorsal penile nerve block plus ring block, Circumcision with Plastibell, Conventional Dissection Method (Drug, procedure) |
| Dates | start 2022-03-01 (estimated), primary completion 2023-03-01 (estimated), completion 2023-03-01 (estimated), first posted 2022-02-10, last updated 2022-02-10 |
| Locations | 1 site in Saudi Arabia |
Related Papers Related Patents Related Grants Related Experts
All trials for Anesthesia All trials for Anesthesia, Local All trials of Caudal block All trials of Dorsal penile nerve block plus ring block
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.
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.
| Arm | Type | Interventions | Description |
|---|---|---|---|
| Caudal block and circumcision with Plastibell, | Experimental | Drug: Caudal block; Procedure: 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 | Experimental | Drug: Caudal block; Procedure: 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 | Active comparator | Drug: Dorsal penile nerve block plus ring block; Procedure: 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 | Active comparator | Drug: Dorsal penile nerve block plus ring block; Procedure: Conventional Dissection Method | Dorsal penile nerve block plus ring block with 0.25% bupivacaine. Circumcision will be done using the conventional dissection method |
Sex: Male, ages: 3 Months to 4 Years, 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
| Facility | City | Country | Status |
|---|---|---|---|
| King Saud University | Riyadh | Saudi Arabia |