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Trials / Completed

CompletedNCT06086106

Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision

Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision: A Prospective Randomized Study"

Status
Completed
Phase
Study type
Observational
Enrollment
90 (actual)
Sponsor
Salmaniya Medical Complex · Other Government
Sex
Male
Age
3 Months – 3 Years
Healthy volunteers
Accepted

Summary

Prospective, randomized, case-controlled trial study. Observation post-operatively: Aims: This study aimed to compare the effectiveness of the caudal block CB with other methods of postoperative pain release.

Detailed description

a study Sample size: all patients, for a total of 90 boys going for circumcision surgery. I was recruited over the course of four months, starting on 1 May 2023. The patients will be divided into three groups: A caudal block(CB), B systemic opioids, and C dorsal penile block (DPNB) Techniques used in pediatric surgeries to provide analgesia for penile surgery such as circumcision. All patients had operations and were observed, and the three groups were compared based on hemodynamic stability, pain scores, duration of sedation, analgesia need, and parental satisfaction. where the Face, Leg, Activity, and Cry Consolability (FLACC) pain scale and behaviors were used to observe and compare the three groups. Pain scores were recorded by separate anesthesiologists or nurses in the post-anesthesia care unit. All statistical work will be carried out using Spss version 27 (Spss Inc., Chicago, USA) and Prism GraphPad version 9.4.1 (GraphPad, San Diego, USA) The categorical and numerical variables and demographic data of three groups were collected and reviewed by two authors. the study has shown that the caudal block produces higher levels of analgesia and a longer period of pain release than the penile block, even if both methods help relieve pain during pediatric surgical procedures.

Conditions

Interventions

TypeNameDescription
PROCEDUREcaudal blockThe caudal block involves the injection of a local anesthetic Bupivacaine dose of 0.75 to 1 ml/kg the maximum volume was 10 mL with 0.25% concentration into the caudal epidural space, targeting the sacral nerve roots. to provide a high effect and duration of analgesia
PROCEDUREDorsal Penile Nerve Block DPNBDPNB is A type of pain control post-operative, often performed as a circumferential infiltration of the root of the penis (ring block). Two skin wheals are raised at the dorsal base of the penis, one on each side just below and medial to the pubic spine. A 25-gauge, 37.5-mm needle is introduced on each side, and the bupivacaine (1 to 1.5 mL) maximum dose 2 ml concentration 0.25% for infants is injected superficially and deep along the lower border of the pubic ramus to anesthetize the dorsal nerve. For a complete ring of infiltration,
DRUGSystemic opioidsSystemic opioids belong to a class of analgesics, they act by attaching to opioid receptors in the brain and spinal cord. For relief of pain, they are frequently utilized in a variety of surgical procedures and can be given intravenously, and in intramuscular injections. Although opioids are considered highly effective in pain control, they can lead to several adverse effects, such as nausea, vertigo, and respiratory depression, some of which can be dangerous.

Timeline

Start date
2023-05-01
Primary completion
2023-08-20
Completion
2023-08-26
First posted
2023-10-17
Last updated
2023-10-17

Locations

1 site across 1 country: Bahrain

Source: ClinicalTrials.gov record NCT06086106. Inclusion in this directory is not an endorsement.

Comparison Between the Caudal Block and Other Methods of Postoperative Pain Relief in Children Undergoing Circumcision (NCT06086106) · Clinical Trials Directory