Clinical trial NCT03911648: Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally
Official title: The Efficacy of Bupivacaine Alone and in Combination With Lidocaine at Performing Caudal Block on Analgesia in Pediatric Patients Underwent Circumcision: A Historical Cohort Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Anesthesia, Local
Keywords: Bupivacaine
Lidocaine
Caudal block
Pediatric urologic surgery
Lead sponsor: Ayancık State Hospital
Sponsor class: OTHER_GOV
First posted: 2019-04-11
Enrollment: 86
Sex: MALE
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The medical records of pediatric patients who underwent circumcision under general anethesia with caudal block over 6 months (01 January 2018-31 June 2018) were analysed.

Brief summary: Optimal analgesia following ambulatory surgery is an important matter for patient satisfaction and it reduces unnecessary hospital admissions. This study investigated whether caudal block with different combinations of local anesthetics can alter postoperative pain scores and additional rescue analgesic use. The investigators also aim to determine the side effects of these technique such as nausea, vomiting, bradycardia, hypotension, respiratory depression, length of hospital stay, first micturition or mobilization times, surgical and anesthetic complications.

Detailed description: Circumcision, which is performed on an outpatient basis is commonly a short durational operation in boys. Postoperative pain and agitation are the most common complaints in children with circumcision. The most important factor affecting the length of hospital stay is to provide an effective analgesia. Various methods are being used to manage postoperative pain such as caudal block, penile block, topical analgesia or intra-venous (iv) analgesics. Caudal block is applicable widely in pediatric day case surgery, providing excellent postoperative analgesia and attenuation of the stress response in children. Opioids can cause several side effects such as respiratory depression, suppression of bowel movements, nausea, vomiting, itching, addiction. Opioid drugs are not recommended in children as well. Lower abdominal surgeries affect dermatomes T10-L1 and blocking these nerve roots provides effective postoperative analgesia. Neuraxial blocks such as epidural and caudal blocks is considered the gold standard regional technique for pain management after lower abdominal surgery, blocking both somatic and visceral pain. Recent studies suggest that lidocaine and bupivacaine can be used in combination or a sole agent when performing regional anesthesia in children. But it remains unknown whether these combinations are useful or simply reflect underlying status. There is no report comparing the effects of bupivacaine alone and in combination with lidocaine at performing caudal epidural block in children. The investigators thus tested the primary hypothesis that combining the two different local anesthetics has a synergistic analgesic effect and can accelerate the onset time and decrease the need for additional analgesic doses. Secondarily, the investigators tested the hypothesis that providing intra-operative and postoperative analgesia reduces the risk of hemodynamic deteriorations, length of hospital stay, first micturition and mobilization times, surgical and anesthetic complications.

Eligibility criteria: Inclusion Criteria:

* American Society of Anesthesiologists (ASA) class 1.
* Patient underwent elective circumcision operation under general anesthesia and caudal analgesia.

Exclusion Criteria:

* Procedures simultaneously underwent another operation unrelated to circumcision.
* Patients who had unsuccessful caudal block.

Primary outcomes:
measure: Number of patients who require rescue analgesic
timeFrame: up to 10 hours
measure: The average pain scores
timeFrame: up to 10 hours
Secondary outcomes:
measure: Number of participants with hypotension or bradycardia.
timeFrame: up to 10 hours
measure: Number of participants with hypertension or tachycardia.
timeFrame: up to 10 hours
measure: Incidence of side effects
timeFrame: up to 10 hours
measure: Time to first mobilization
timeFrame: up to 10 hours
measure: Time to first micturition
timeFrame: up to 10 hours
measure: The length of hospital stay
timeFrame: up to 10 hours
Other outcomes:
Locations:
city: Sinop
country: Turkey
facility: Ayancık State Hospital
Study officials:
affiliation: Ayancık State Hospital
name: ayse gulsah atasever, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Atasever AG, Ermis O, Demir BS, Kasali K, Karadeniz MS. Comparison of bupivacaine alone and in a combination with lidocaine for caudal block in patients undergoing circumcision: A historical cohort study. Turk J Urol. 2019 Nov 29;46(3):243-248. doi: 10.5152/tud.2019.19191. Print 2020 May.