High Volume Caudal Study

Early Phase 1

Completed

• Conditions: Male Circumcision
• Interventions: Drug: High Volume-Low Concentration without Clonidine; Drug: High Volume-Low Concentration with clonidine

• Registration Number: NCT04263064
• Lead Sponsor: Medical University of South Carolina

Brief Summary

The primary objective is to evaluate the effect of clonidine on the duration of analgesia provided by a high volume-low concentration caudal block for pediatric aurgical procedres. In addition, caudal clonidine's effect on length of recovery and post-operative emergence agitation will be measured.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-02-01
• Study First Submitted QC: 2020-02-07
• Study First Posted: 2020-02-10
• Study Start: 2020-03-06
• Primary Completion: 2022-08-17
• Study Completion: 2022-08-19
• Status Verified: 2023-03
• Last Update Submitted: 2023-03-13
• Last Update Posted: 2023-03-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 129

Inclusion Criteria

• 3 years old or less
• Weight <= 13.3kg
• American Society of Anesthesiology Physical Status (ASA) 1 or 2
• Undergoing circumcision surgery
• Patients whose plan of care includes caudal block

Exclusion Criteria

• Known allergy to clonidine, epinephrine, or amide local anesthetics
• Inability or unwillingness of parent or legal guardian to give informed consent

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High Volume-Low Concentration without Clonidine	High Volume-Low Concentration without Clonidine	The control for this study will be a High Volume-Low Concentration (1.5cc/kg of 0.15% ropivacaine and 5mcg/cc epinephrine).
High Volume-Low Concentration with clonidine	High Volume-Low Concentration with clonidine	The study intervention will be High Volume-Low Concentration with clonidine (1.5cc/kg of 0.15% ropivacaine, with 1mcg/cc of clonidine and 5mcg/cc epinephrine).

Primary Outcome Measures

Name	Time	Method
Administration of Rescue Pain Medications	24 hours	Data will be collected and analyzed on the need for rescue pain medications by collecting doses of opioids administered the Post Anesthesia Care Unit.
Presence of Pain	24 hours	The effect of clonidine on the duration of the analgesia provided by a high volume-low concentration caudal will be measured in the Post Anesthesia Care Unit pain assessments using CHEOPS score every at 0, 30, 60, and 90 minutes after arrival to PACU.; The CHEOPS pain score tool is an observational scale for measuring postoperative pain in children aged 1-7 yrs. The tool includes six categories of pain behavior, each with 3-4 levels and scores range from 4 points (no pain) to 13 points (the worst pain).
Time to first Administration of Acetaminophen	24 hours	24 hours after discharge a phone call interview will be conducted to obtain the time of the first dose of acetaminophen

Secondary Outcome Measures

Name	Time	Method
Hemodynamic Changes	24 hours	A change of greater than 20% in heart rate or blood pressure from their baseline established in the preoperative area
Sedation Levels	24 hours	Measured in PACU utilizing Ramsay Sedation Scale at 0, 30, 60, and 90 minutes after arrival in PACU. The Ramsay sedation scale is a scoring of responses (1-6) \[1=anxious or restless, 2=cooperative, oriented, tranquil, 3=responding to commands, 4=brisk response to stimulus, 5=sluggish response to stimulus, 6=no response to stimulus\].
Incidence of Emergence Delirium	24 hours	The incidence of emergence delirium will be collected utilizing the PAED Scale at 0, 30, 60, and 90 minutes after arrival to the Post Anesthesia Care Unit. The PAED scale will measure the presence of delirium by scoring behaviors from 1-4 (1=calm, 2=not calm but consolable, 3=moderately agitate, restless or not easily calmed, 4=combative, excited, thrashing around)
Average Time to Discharge	24 hours	time of arrival to PACU and discharge time

Trial Locations

Locations (1)

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States