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CRITICAL APPRAISAL

A comparison of high volume/low concentration and low volume/high concentration


ropivacaine in caudal analgesia for pediatric orchiopexy.

Jeong-Yeon Hong, Sang W. Han, Won O. Kim, Jin S. Cho, Hae K. Kil.
Anesthesia and Analgesia, October 2009, volume:109, page: 1073–8.

General
1. Is the clinical question clearly defined? Yes
Patient : Seventy-three ASA physical status I unpremedicated children, aged 1–5
year old, who were scheduled for daycase unilateral orchiopexy.
Intervention : Constant dose of 2.25 mg/kg of Ropivacaine prepared as 1.5 mL/kg of
0.15% solution (high volume/low concentration [HVLC])
Comparison : 1.0 mL/kg of 0.225% (low volume/high concentration [LVHC])
Outcome(s) : The primary : drug spread in epidural space
The secondary : duration of analgesia, sum of patients and time to first
oral acetaminophen.
2. What is the clinical question evaluating
Whether the volume or concentration of local anesthetic influences the spread and quality
of caudal analgesia when the total drug dose is fixed.
3. What was the study design? randomized, prospective, observer-blinded study
4. Was there a clearly focused clinical question and primary hypothesis?
Yes. By increasing the volume of local anesthetics, a higher initial level of blockade
might extend the analgesic duration.
5. Are there any declare conflict of interest that may bias the result of the study? No

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Methodology
Population
1. What was the sampling method?
Randomized, observer-blinded of 1-5 years old ASA 1 unpremedication child that
scheduled for daycase orchiopexy.
2. Were the inclusion/ exclusion criteria clearly defined? Yes
The inclusion criteria: ASA physical status I, Unpremedicated children, aged 1–5 year,
scheduled for daycase unilateral orchiopexy.
The exclusion criteria: Parents refusal, A history of allergic reactions to any local
anesthetics, bleeding diathesis, infections at the puncture sites, preexisting neurological
disease.
3. Did the sample include a representative spectrum of subject? Yes
4. How was the sample size determined?
Sample size calculation was based on the data published by Verghese et al., who found
the incidence of postoperative rescue analgesics to be 90.3% and 66.7% in children who
received caudal analgesia in LVHC (0.25% bupivacaine, 0.8 mL/kg) and HVLC (0.2%
bupivacaine, 1.0 mL/kg), respectively. Thirty-one patients in each group allowed an α of
0.05 and β of 0.1. Power analysis for the incidence of rescue analgesics was also
performed based on a similar study by Silvani et al. They demonstrated that first rescue
analgesics were needed after 520 min in the LVHC group (0.375% ropivacaine, 0.5
mL/kg) and 952 min in the HVLC group (0.1% ropivacaine, 1.8 mL/kg) after hypospadia
repair. The calculated sample size was at least 27 in each group using an α value of 0.05
and power of 0.9. Seventy-three patients were enrolled for protocol omissions.
5. Do the authors explain how selection bias was minimized? Yes
Restriction in inclusion and exclusion criteria.
6. Was allocation of subject to intervention and control groups concealed from the
researchers? No, but it was evaluated by independent evaluator and concealed from
observer who collect all the postoperative data.
Confounders

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1. Were the intervention group and control group similar at the start of the study?
There were no division for intervention and control group. But the HVLC group and
LVHC group were similar at the start of the study.
2. Were the group treated equally except for the receipt of intervention?
Yes. All the patient get standard monitoring was applied, and anesthesia was induced
with 8 vol% of sevoflurane in 100% oxygen by an anesthesiologist who was unaware of
the patient’s group assignment. Tracheal intubation was performed without muscle
relaxants, and mechanically controlled ventilation was used to maintain end-tidal carbon
dioxide at 35+ 5 mm Hg. After induction of anesthesia, a caudal block was performed by
a second anesthesiologist who was not involved in the subsequent management of the
patient. With the patient in the lateral position, a 5 cm short beveled 22-gauge caudal
needle was inserted after measuring the optimal angle using ultrasonography
(LOGIQe™, GE Healthcare, Wauwatosa, MI).
After emerging from anesthesia, patients were managed by an observer blinded to group
allocation in the recovery room (RR). Postoperative pain was assessed using the
children’s Hospital of Eastern Ontario Pain Scale (CHEOPS).7 Rescue fentanyl
(0.5mcg/kg) was administered if two coupled observations separated by a 5-min waiting
period yielded CHEOPS >4. Motor blocks were assessed with a modified Bromage score
(0: no motor block, 1: able to move legs, and 2: unable to move legs).8 Postoperative
sedation was evaluated using 8-point modified Ramsay Sedation Scale.
3. How were patient allocated to the treatment and control groups?
Patients were allocated to their respective group by computer generated randomization.
4. Were either the researchers or subjects blinded to the treatment? Yes
5. Was the blinding process clearly explained? Yes.
The spread of local anesthesia drug in epidural space was evaluated by anesthesiologist
blinded to the protocol and confirmed by independent radiologist. The postoperative data
was collected by blinded observer.
6. Was the adequate placebo used in the controlled group? No. this study did not use
control group
7. Were the clinical endpoints measured clearly stated? Yes
8. How was the clinical endpoint measured ?
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Fluoroscopic images of the lumbo-sacral or thoracic-sacral area were saved, and the
spread levels were determined by an anesthesiologist blinded to the protocol and their
determinations were confirmed by an independent radiologist. Surgery was allowed to
begin 10 min after performing the block. Peripheral oxygen saturation, heart rate, and
noninvasive arterial blood pressure were monitored and recorded throughout the surgery.
All measurements were recorded at 5-min intervals. End-tidal sevoflurane was adjusted
according to clinical variables (arterial blood pressure or heart rate within 20% of
baseline or absence of responses such as movement, tearing, or sweating). The minimum
alveolar anesthetic concentration-hour was calculated. After emerging from anesthesia,
patients were managed by an observer blinded to group allocation in the recovery room
(RR). Postoperative pain was assessed using the Children’s Hospital of Eastern Ontario
Pain Scale (CHEOPS). Rescue fentanyl (0.5mcg/kg) was administered if two coupled
observations separated by a 5-min waiting period yielded CHEOPS > 4. Motor blocks
were assessed with a modified Bromage score (0: no motor block, 1: able to move legs,
and 2: unable to move legs). Postoperative sedation was evaluated using 8-point modified
Ramsay Sedation Scale. Recovery times were defined as the time from when the patient
entered the RR to when they could drink water, void, and were discharged. The discharge
criteria for children included clear consciousness, stability of vital signs, ability to
tolerate oral fluids and void, ageappropriate level of ambulation, and absence of side
effects. A telephone interview with the patient’s parents 24 hr later assessed the demands
for additional analgesics. The interviewer, who was blinded to the treatment group,
documented these data in the patient’s medical record. The time to first supplemental oral
acetaminophen (first acetaminophen time) was defined as the time from the end of
surgery to the first registration of a VAS (0–10) > 4 by parent’s observation.

Reliability And Validity


1. Was a valid measurement of the clinical endpoint made? Yes
2. Were the endpoints assessed using validated measuring methods/ instruments? Yes
3. Is there evidence provided for the reliability of the measuring instruments/ methods
used?No

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4. Was training and standardization used to improve the consistency of measurements
made? No
5. Was follow up complete and sufficient duration? Yes
6. Has an appropriate methods of statistical analysis been chosen? The authors only stated
the model of statistical test that will be used when appropriate. They did not describe which
test for specific data. The only statistical test that was mentioned clearly was the linear
regression to to determine whether epidural spread level of ropivacaine is associated with
first oral acetaminophen time after discharge. A P value _0.05 was considered significant.
7. How many groups were compared? Two groups

Result
1. Was the study analyzed using an intention to treat analysis? Not Stated
2. How precise was the estimate of the treatment effect?
The spread levels (median with ranges) of ropivacaine confirmed by fluoroscopic
examination (Fig. 1) were T11 (T8–L2) in the LVHC group and T6 (T3–11) in the HVLC
group (Fig. 2, P = 0.010). Differences in intraoperative hemodynamic changes between the
two groups were not statistically significant. In the RR, there were no significant differences
in recovery profiles between the two groups (Table 2). There were no patients who needed
rescue analgesics in the RR. CHEOPS assessed at 30-min intervals in the RR showed
similarities within the two groups (Fig. 4). The spread level of ropivacaine correlated
significantly with the first oral acetaminophen time after discharge in both the groups (Fig.
5).

Applicability
1. Are your patients similar to target population? Yes
2. Were all the relevant outcome measures considered? Yes
3. Will the intervention help your patient population? Yes
4. Are the benefits of the intervention worth the risks and costs? Yes
5. Have the patient values and prefenrences been considered? Yes

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