Clinical trial NCT02436265
Conditions: Surgery
Keywords: Neuraxial Caudal Block Anesthesia Dexamethasone
Sponsor: Indiana University
Start date: 2015-02-01; Completion date: 2017-12-01
Enrollment: 8 participants; Allocation: RANDOMIZED; Intervention model: PARALLEL

Brief summary:
Caudal injection of local anesthetic is a neuraxial technique routinely performed on young children for postoperative analgesia after lower abdominal and lower extremity surgical procedures. One of the major limitations of the use of single shot neuraxial injections for this purpose is the limited duration of action of the injected local anesthetic. Adjuvant medications, such as clonidine and epinephrine, have been added to the local anesthetic to prolong the duration of the neuraxial block, with varying results. Dexamethasone is a synthetic glucocorticoid steroid commonly used in the perioperative setting for a multitude of indications, including the prolongation of local anesthetic based analgesia. It has been shown that the administration of dexamethasone either intravenously or via perineural injection can significantly increase the duration of analgesia derived from a local anesthesia based peripheral nerve block. Literature also suggests that the effect of dexamethasone is equivalent whether given intravenously or perineurally. Interest in dexamethasone enhanced caudal analgesia exists and a previous study noted that caudal anesthesia can be prolonged by intravenous dexamethasone. The study was criticized for using a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the pediatric population outside of airway procedures, which may expose patients to dose related side effects of dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective for analgesic prolongation, but no direct study of low dose intravenous dexamethasone in combination with caudal anesthesia has been performed.

Detailed description:
As dexamethasone is an inexpensive and commonly used medication, it would be beneficial to know if a similar prolongation of analgesia occurs when a local anesthetic is given neuraxially in combination with low dose intravenous dexamethasone. This project will investigate the efficacy of low dose intravenous (IV) dexamethasone in prolonging the duration of post operative analgesia provided by an intraoperative caudal injection of local anesthetic. All patients will be enrolled in the study the day of surgery, in the preoperative waiting area. The study will be explained by an anesthesiologist with extensive knowledge of the protocol. Computer randomization will occur for each patient. Randomization will not increase the risk to either group as all medications and techniques utilized for this study are commonly accepted for routine care for these patients.

Arms: arm 1: Group 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine arm 2: Group 2 Ropivacaine/dexamethasone Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine and 0.1mg/kg of intravenous dexamethasone immediately after caudal placement
Interventions: intervention 1: Dexamethasone intervention 2: Ropivacaine
Intervention descriptions: intervention 1: IV dexamethasone intervention 2: Ropivacaine only

Protocol documents:
Prot_SAP_000.pdf: 
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Low Dose IV Dexamethasone in Prolonging Caudal 
Anesthesia in Children Undergoing Genitourinary 
Surgery 
 
 
 
Indiana University School of Medicine 
Riley Hospital for Children 
 
 
 
Principal Investigator: Aali Shah, MD 
      Co-Investigators:   Nicole Horn, MD; Brian Egan, 
MD 
      
 
Version Date:  
 05/13/2016 
 
 
 
 
 
 


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Introduction: 
Caudal injection of local anesthetic is a neuraxial technique routinely performed on young 
children for postoperative analgesia after lower abdominal and lower extremity surgical 
procedures. One of the major limitations of the use of single shot neuraxial injections for this 
purpose is the limited duration of action of the injected local anesthetic. Adjuvant medications, 
such as clonidine and epinephrine, have been added to the local anesthetic to prolong the 
duration of the neuraxial block, with varying results.  Dexamethasone is a synthetic 
glucocorticoid steroid commonly used in the perioperative setting for a multitude of indications, 
including the prolongation of local anesthetic based analgesia. The administration of 
dexamethasone either intravenously or via perineural injection can significantly increase the 
duration of analgesia derived from a local anesthesia based peripheral nerve block. Literature 
also suggests that the effect of dexamethasone is equivalent when given intravenously or 
perineurally. Interest in dexamethasone enhanced caudal analgesia exists, and a previous study 
noted that caudal anesthesia can be prolonged by intravenous dexamethasone.  The study was 
criticized for using a higher dose of dexamethasone (0.5 mg/kg) than is routinely used in the 
pediatric population outside of airway procedures, which may expose patients to dose related 
side effects of dexamethasone. A large meta-analysis has suggested that 0.1 mg/kg is effective 
for analgesic prolongation, but no direct study of low dose intravenous dexamethasone in 
combination with caudal anesthesia has been performed. 
 
Rationale/Specific Aim 
As dexamethasone is an inexpensive and commonly used medication, it would be beneficial to 
know if a similar prolongation of analgesia occurs when a local anesthetic is given neuraxially in 
combination with low dose intravenous dexamethasone. This project will investigate the efficacy 
of low dose intravenous (IV) dexamethasone in prolonging the duration of post-operative 
analgesia provided by an intraoperative caudal injection of local anesthetic. 
 
Inclusion/Exclusion: 
Inclusion Criteria: 
 Age 2 years-10 year 
 Scheduled for elective inpatient genitourinary surgical procedure 
 Caudal anesthesia within standard of care for surgical procedure 
 Have provided parental consent and assent in accordance with the Institutional Review 
Board requirements 
Exclusion Criteria 
 Abnormal/difficult anatomy  
 Known allergy to ropivacaine or dexamethasone 
 History of documented chronic pain 
 Existing infection at site of intended injection  
 


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Enrollment: 
All patients will be enrolled in the study the day of surgery, in area private hospital setting.  
Subjects/subject parents may be approached to consent either before or after surgery, provided 
all inclusion criteria is met and no exclusion criteria. The study will be explained by a member of 
the research team with extensive knowledge of the protocol.  All medications and techniques 
utilized for this study are commonly accepted for routine care for these patients.   
Study Procedures: 
1. Study design: prospective data collection. 
2. Comparison Groups:  We will collect data on 94 subjects having a GU procedure and 
caudal as standard of care.  We will collect information on 47 subjects who receive 
caudal only.  We will collect information on an additional 47 subjects who receive a 
caudal and IV dexamethasone.  No other adjuvant medication will be used.  
3. Study and timeline of interventions   
a. Preoperative: Patients enrolled in this study may receive 0.5mg/kg up to 15mg 
total of oral midazolam if deemed necessary for anxiolysis by operating room or 
study anesthesiologist, 15 to 30 minutes prior to anesthetic induction. 
b. Intraoperative: Subjects will undergo induction of anesthesia by inhalation of 
sevoflurane and oxygen.  An intravenous catheter (IV) will be placed, followed by 
2-3mg/kg of propofol if necessary.  The airway device (LMA or ETT) will then 
be placed.  Following confirmation of airway placement, the patient will be rolled 
in left or right lateral decubitus position and caudal epidural will be placed under 
sterile conditions.  To be enrolled as caudal + IV dexamethasone, subjects must 
receive IV dexamethasone right after caudal placement.  Should the IV 
dexamethasone be given at the end of the surgical procedure, subject will be 
considered a screen failure.  All patients will be maintained on sevoflurane in 
accordance to patient anesthetic requirements as determined by anesthesia 
provider.   
c. Postoperative: All patients will receive routine PACU care.  Pain and anxiety 
scores will be recorded according to routine PACU practice.  All patients will 
have their pain orders written by the anesthesia acute pain service and pain scores 
monitored per hospital protocol.  The patient will have a final pain evaluation by 
the Acute Pain Service attending the day following caudal placement. 
d. Measured end-points:   
i. Type of procedure 
ii. Time of caudal 
iii. Length of surgical procedure 
iv. Time to first analgesic dose 
v. Amount of pain medicine received in PACU 
vi. Amount of pain medicine received during floor stay 
vii. Pain scores over 24 hour period as obtained by floor nurse during routine 
care 


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viii. Patient/parent satisfaction 
ix. Highest pain level in 24 hour period 
x. Adverse events 
Risks to patient/ adverse event response: 
Per inclusion criteria, patients enrolled in this study will be receiving anesthesia, surgery, and a 
caudal as standard of care.  IV dexamethasone will be given at the discretion of the 
anesthesiologist.  Risks related to the study are limited to potential loss of confidentiality.   
Subject Withdrawal:   
A patient may withdraw from enrollment at any time.  At the time of withdrawing, data already 
collected will be kept and utilized, but no more data for the study will be collected. 
Statistical Considerations: 
A two tailed paired t-test will be utilized to evaluate a clinically significant difference of 2 hours 
between the two groups. Each group will contain 47 participants in order to achieve a power of 
0.9 and Alpha of 0.05. 
Privacy/Confidentiality: 
Participant privacy is an important goal of the researchers.  Only the principal investigator and 
IRB approved study personnel will have access to identifiable data.  PHI will be stored in the 
locked Anesthesiology Offices. 
Follow up/Record Retention: 
The participation in the study begins with induction of anesthesia and ends after the 24 hour 
follow up.  The patient data related to the study will be passed on to the principal and co-
investigators, and the anesthetic record will be placed in the patient’s medical chart.  Data will be 
entered and stored securely in a REDCap database.  Following completion of the study and after 
the require amount of time per Indiana Laws, all copies of data collected will be physically 
destroyed. 
References: 
1. Desmet, M. I.V. and perineural dexamethasone are equivalent in increasing the 
analgesic duration of a single-shot interscalene block with ropivacaine for shoulder 
surgery: a prospective, randomized, placebo-controlled study. Br J Anaesth. 2013 
Sep;111(3):445-52. doi: 10.1093/bja/aet109. Epub 2013 Apr 15. 
2. Effect of dexamethasone in combination with caudal analgesia on postoperative pain 
control in day-case paediatric orchiopexy Hong.Br. J. Anaesth. (2010) 105 (4): 506-510. 
doi: 10.1093/bja/aeq187 
3. Perioperative Single Dose Systemic Dexamethasone for Postoperative Pain A Meta-
analysis of Randomized Controlled Trials Gildasio S. De Oliveira, Jr., M.D.,* Marcela D. 
Almeida, M.D.,† Honorio T. Benzon, M.D.,‡Robert J. McCarthy, Pharm.D. 


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Anesthesiology: September 2011 - Volume 115 - Issue 3 - p 575–588 doi: 
10.1097/ALN.0b013e31822a24c2