Analgesic Efficacy of Lidocaine Plus Bupivacaine Versus Bupivacaine Alone Caudally

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

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.

Study Overview

• Status: Completed
• Conditions: Anesthesia, Local
• Intervention / Treatment: 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%

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.

• Study Type: Observational
• Enrollment (Actual): 86

Contacts and Locations

Study Locations

• Turkey
  • Sinop, Turkey, 57600
    • Ayancık State Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 11 years (CHILD)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: Male

• 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.

Description

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.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group B; 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%; Caudally; Other Names: Marcaine
Group L; 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%; Caudally; Other Names: Marcaine, Xylocaine

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Ayancık State Hospital
• Investigators: Principal Investigator: ayse gulsah atasever, MD, Ayancık State Hospital

Publications and helpful links

General Publications

• 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.

Helpful Links

• Brennan J. Modern day-case anaesthesia for children. Br J Anaesth. 1999;83:91-103.
• Suresh S et al. Are Caudal Blocks for Pain Control Safe in Children? An Analysis of 18,650 Caudal Blocks from the Pediatric Regional Anesthesia Network (PRAN) Database. Anesth Analgesia. 2015;120:151-156
• Nancy B et al. Regional anesth and Pain Management for the Pediatric Patient. ınternatıonal anesthesıology clınıcs:2012; 50,4,83-95
• Corliss A, Alyssa A, Timothy J, Danielle A Hamilton. Buffered lidocaine and bupivacaine mixture - the ideal local anesthetic solution? Plast Surg 2015: 23; 2, 87-90

Study record dates

Study Major Dates

• Study Start (ACTUAL): July 1, 2018
• Primary Completion (ACTUAL): July 15, 2018
• Study Completion (ACTUAL): August 15, 2018

Study Registration Dates

• First Submitted: April 9, 2019
• First Submitted That Met QC Criteria: April 9, 2019
• First Posted (ACTUAL): April 11, 2019

Study Record Updates

• Last Update Posted (ACTUAL): April 11, 2019
• Last Update Submitted That Met QC Criteria: April 9, 2019
• Last Verified: April 1, 2019

More Information

Terms related to this study

• Keywords: Lidocaine; Bupivacaine; Caudal block; Pediatric urologic surgery
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Anti-Arrhythmia Agents; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Membrane Transport Modulators; Anesthetics, Local; Voltage-Gated Sodium Channel Blockers; Sodium Channel Blockers; Lidocaine; Bupivacaine
• Other Study ID Numbers: 2019/366

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No