Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Anesthesia, Local

Intervention / Treatment
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* Drug: 0.5 ml.kg-1 bupivacaine 0.25%
* Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 Years

Sexes Eligible for Study
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Male

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group B;<br>Patients had 0.5 ml.kg-1 bupivacaine 0.25% caudally, the maximum given volume was 20 ml. N=42 | Drug: 0.5 ml.kg-1 bupivacaine 0.25%<br>* Caudally<br>* Other names: Marcaine;|
| Group L;<br>Patients had 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1% caudally, the maximum given volume was 20 ml. N=44 | Drug: 0.5 ml.kg-1 bupivacaine 0.25% with the addition of 3 mg/kg lidocaine 1%<br>* Caudally<br>* Other names: Marcaine, Xylocaine;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who require rescue analgesic | iv/po analgesic use | up to 10 hours | 
| The average pain scores | Pain scores were typically recorded on a scale from 0 to 10 by visual analogue scale (VAS), whereas, in children younger than 4 years the FLACC (Face, Legs, Activity, Cry, Consolability) score was used. | up to 10 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants with hypotension or bradycardia. | An intra-operative decrease in blood pressure(BP) or heart rate(HR) of more than 20% from preoperative values was defined as hypotension or bradycardia, respectively, and was treated with rapid infusion of fluids or with atropine 0.01 mg/kg. | up to 10 hours | 
| Number of participants with hypertension or tachycardia. | An intraoperative increase in BP or HR by more than 20% was defined as insufficient analgesia and was treated with fentanyl 1 mcg/kg iv. | up to 10 hours | 
| Incidence of side effects | Nausea, vomiting, respiratory depression | up to 10 hours | 
| Time to first mobilization | Time to first mobilization | up to 10 hours | 
| Time to first micturition | Time to first micturition | up to 10 hours | 
| The length of hospital stay | Hospitalisation, hr | up to 10 hours | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bupivacaine, Lidocaine, Caudal block, Pediatric urologic surgery