Low Dose IV Dexamethasone in Prolonging Caudal Anesthesia in Children Undergoing Genitourinary Surgery

Indiana University

Status and phase: Terminated; Phase 4

Conditions: Surgery

Treatments: Drug: Dexamethasone; Drug: Ropivacaine

Study type: Interventional

Funder types: Other

Identifiers

NCT02436265

1408968524

Details and patient eligibility

About

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.

Full 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.

Enrollment: 8 patients

Sex: All

Ages: 2 to 10 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age 2 to 10 years
• Scheduled for elective inpatient genitourinary surgical procedure
• Caudal anesthesia 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 2 patient groups

Group 1 Ropivacaine

Sham Comparator group

Description:

Group 1 Ropivacaine Intervention: Each patient will receive a caudal with 1ml/kg of 0.2% ropivacaine

Treatment:

Drug: Ropivacaine

Group 2 Ropivacaine and Dexamethasone

Active Comparator group

Description:

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

Treatment:

Drug: Ropivacaine

Drug: Dexamethasone