Caudal Block Versus Dorsal Penile Nerve Block Plus Ring Block for Pain Management of Different Surgical Techniques of Circumcision in Infants and Children
NCT05233683 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 120
Last updated 2022-02-10
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.
Conditions
- Anesthesia
- Anesthesia, Local
- Analgesia
- Pediatric ALL
- Pain, Postoperative
- Pain, Acute
Interventions
- DRUG
-
Caudal block
Caudal block will be performed in lateral position with 0.25% bupivacaine in the dose of 0.75 ml/kg containing 1 mic/kg dexmedetomidine. The patients will be turned back to the supine position after the block placement and the head of the patient will be placed in the neutral position. 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.
- DRUG
-
Dorsal penile nerve block plus ring block
It will be performed with the child in the supine position. Following skin preparation and palpation of the arch of the lower border of the symphysis pubis, the base of the penis will be gently pulled down, and a 25-G needle will be inserted at 10 and 2.0 "O" clock position to a depth of 0.25-0.5 cm (under Bucks' fascia) and 1 ml + 0.1ml X weight of the patient) of local anesthetic (0.25% bupivacaine) will be injected at each point after negative aspiration and then RB will be done in the form of a circumferential subcutaneous ring at the level of the base of the penis. 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.
- PROCEDURE
-
Circumcision with Plastibell
Circumcision with Plastibell
- PROCEDURE
-
Conventional Dissection Method
Conventional Dissection Method
Sponsors & Collaborators
-
King Saud University
lead OTHER
Principal Investigators
-
Mansoor Aqil, FCPS · King Saud University
Study Design
- Allocation
- RANDOMIZED
- Purpose
- SUPPORTIVE_CARE
- Masking
- DOUBLE
- Model
- PARALLEL
Eligibility
- Min Age
- 3 Months
- Max Age
- 4 Years
- Sex
- MALE
- Healthy Volunteers
- Yes
Timeline & Regulatory
- Start
- 2022-03-31
- Primary Completion
- 2023-03-31
- Completion
- 2023-03-31
Countries
- Saudi Arabia
Study Locations
More Related Trials
-
Safety Profile of Ropivacaine in Dorsal Penile Nerve Block for Male Circumcision: a Large Cohort Study in Children
NCT06545058 ·Status: COMPLETED
-
Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally
NCT03911648 ·Status: COMPLETED
-
Analgesia in Children Using Caudal Epidural Ropivacaine
NCT01494272 ·Status: COMPLETED
-
Ultrasound-guided Rectus Sheath Block for Post-operative Pain Control Following Umbilical Hernia Repair
NCT00836134 ·Status: COMPLETED ·Phase: NA
-
Caudal Versus Rectus Sheath Study
NCT01394523 ·Status: TERMINATED ·Phase: PHASE2/PHASE3
-
Comparison of Analgesic Effect of Magnesium Added to Ropivacaine and Ropivacaine Alone in Caudal Analgesia on Postoperative Pain Control in Pediatric Patients Undergoing Inguinal Hernia Repair
NCT01679353 ·Status: COMPLETED ·Phase: NA
-
Comparing Pain Relief Between Two Methods of Freezing Injections in Children Having Their Appendix Removed
NCT06945263 ·Status: ENROLLING_BY_INVITATION ·Phase: NA
-
The Use of Lignocaine and Bupivacaine Mix in Adult Safe Male Circumcision
NCT02245126 ·Status: COMPLETED ·Phase: NA
-
Pediatric Caudal Anesthesia Block. And Pain Control
NCT05581940 ·Status: COMPLETED
-
Tramadol in Penial Block Does it Improve Efficiency of Postoperative Analgesia in Circumcision
NCT03260439 ·Status: COMPLETED ·Phase: NA
-
Caudal Ketamine-bupivacaine More Effective Than Bupivacaine-saline
NCT05444036 ·Status: COMPLETED ·Phase: PHASE1
-
Transversus Abdominis Plane Block in Pediatrics: Volume or Concentration ?
NCT02064088 ·Status: UNKNOWN ·Phase: NA
-
Percutaneous Rectus Sheath Block Versus Intra-operative Rectus Sheath Block for Pediatric Umbilical Hernia Repair
NCT02341144 ·Status: COMPLETED ·Phase: NA
-
Pediatric Ilioinguinal / Iliohyogogastric Nerve Block
NCT02990884 ·Status: UNKNOWN ·Phase: NA
-
Postoperative Pain Relief in Children: Comparing Caudal Bupivacaine Alone Versus Bupivacaine With Dexmedetomidine for Infra-Umbilical Surgeries Under General Anesthesia
NCT07121764 ·Status: COMPLETED ·Phase: PHASE4
-
Opioid Sparing Analgesia: Dexmedetomidine Versus Lidocaine for Intracranial Surgeries in Children
NCT04535089 ·Status: COMPLETED ·Phase: PHASE1/PHASE2
-
Preoperative Versus Postoperative Ultrasound-guided Rectus Sheath Block for Sleep Quality and Cytokines of Patients
NCT02477098 ·Status: COMPLETED ·Phase: PHASE4
-
Nalbuphine as an Adjuvant to Levobupivacaine in Caudal Analgesia in Children
NCT05617976 ·Status: COMPLETED ·Phase: NA
-
Very Low Dose Caudal Morphine for Postoperative Pain Management
NCT00938821 ·Status: COMPLETED
-
Effect of Intravenous Dexamethasone With Pudendal Nerve Block on Postoperative Pain in Pediatric Hypospadias Repair
NCT03902249 ·Status: COMPLETED ·Phase: PHASE4
-
Uterovaginal Plexus Block With Articaine for Intrauterine Device Placement Patients Who Are Indicated for the Use of Copper IUD as a Contraceptive Method Will be Invited to Participate in This Research.
NCT05252117 ·Status: UNKNOWN ·Phase: PHASE4
-
Does Use of Ultrasound Reduce the Rate of Sham Caudal Block in Children
NCT03283865 ·Status: WITHDRAWN ·Phase: NA
-
The Impact of Preemptive Epidural Analgesia on Acute Postoperative Pain in Pediatric Orthopedic Surgery
NCT02813018 ·Status: COMPLETED ·Phase: NA
-
Pain Prevention During Propofol Infusion in Pediatric: Hypnoanalgesia of the Hand Versus Lidocaine.
NCT03453723 ·Status: COMPLETED ·Phase: PHASE4
-
Analgesic Efficacy After Umbilical Hernia Repair in Children
NCT00578136 ·Status: COMPLETED ·Phase: NA