Unique ID issued by UMIN | UMIN000044487 |
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Receipt number | R000050758 |
Scientific Title | SAFETY AND EFFICACY OF PATIENT CONTROLLED EPIDURAL ANALGESIA VERSUS CONVENTIONAL EPIDURAL ANALGESIA |
Date of disclosure of the study information | 2021/06/10 |
Last modified on | 2021/06/10 00:05:37 |
EVALUATION OF SAFETY AND EFFICACY OF PATIENT CONTROLLED EPIDURAL ANALGESIA VERSUS CONVENTIONAL EPIDURAL ANALGESIA
PCEA VS CONVENTIONAL EPIDURAL ANALGESIA
SAFETY AND EFFICACY OF PATIENT CONTROLLED EPIDURAL ANALGESIA VERSUS CONVENTIONAL EPIDURAL ANALGESIA
SAFETY AND EFFICACY OF PCEA
Asia(except Japan) |
IN ORTHOPEDIC LOWER LIMB SURGERIES
Anesthesiology |
Others
NO
To compare the quality of postoperative analgesia in patients receiving patient
controlled epidural analgesia versus conventional epidural analgesia
To compare the quality of postoperative sedation score in patients receiving
patient controlled epidural analgesia versus conventional epidural analgesia
To compare the hemodynamic stability in patients receiving patient controlled
Epidural analgesia versus conventional epidural analgesia.
Safety,Efficacy
Confirmatory
Not applicable
Hemodynamic parameters
Quality of postoperative analgesia
Post operative adverse effect
Interventional
Parallel
Randomized
Individual
Single blind -participants are blinded
Active
NO
NO
Institution is not considered as adjustment factor.
NO
Pseudo-randomization
2
Treatment
Medicine |
patient controlled epidural analgesia
Intermittent epidural bolus
18 | years-old | <= |
65 | years-old | >= |
Male and Female
Either sex
ASA grade 1 and 2
Age group between 18 to 65 years
Elective orthopedic lower limb surgeries of approximately 2 to 3 hrs duration
Patient refusal
Neuromuscular disorders
Infection at the puncture site
Bleeding disorders
Obesity (BMI > 30 kg/mts2)
History of allergy and sensitivity to local anesthetics.
Patient unable to understand the visual analog score
Patients of significant cardiovascular, renal, hepatic, pulmonary diseases
Failure of spinal anesthesia
60
1st name | venu |
Middle name | gopal |
Last name | tatineni |
maharishi markandeshwar university
anaesthesia
133207
mullana
9642222188
drtatinenivenu@gmail.com
1st name | babita |
Middle name | |
Last name | ramdev |
maharishi markandeshwar university
anaesthesia
133207
department of anaesthesia , mullana
9530581040
drtatinenivenu@gmail.com
mmu, anaesthesia
maharishi markandeshwar university
Other
maharishi markandeshwar university
mmu, mullana
9555522188
hod.anaesthesia@mmumullana.org
NO
2021 | Year | 06 | Month | 10 | Day |
Unpublished
60
The heart rate and mean arterial pressure at 6, 10, 14 hours after catheter activation was more after catheter activation postoperatively in intermittent epidural bolus group. At 2, 6, 10, 14, 18, 22 and 24 hours after catheter activation there is significant increase in VAS score and also more people received rescue analgesia in intermittent epidural bolus group compared to PCEA group.There is lesser analgesic consumption and more satisfaction in PCEA group
2021 | Year | 06 | Month | 09 | Day |
Side effects such as nausea, vomiting, hypotension, bradycardia, pruritus, retention of urine, respiratory depression were observed, documented and treated
The following parameters were recorded for 24 hours postoperatively in both Group1 and Group 2 at 1st, 2nd, 6th, 10th, 14th, 18th, 22nd, and the 24th hour after the catheter activation. Heart Rate, Mean arterial blood pressure, Oxygen saturation, pain by using a visual analog score, motor block by using a the modified bromage scale, pruritus, sedation were documented in the above said interval.
Completed
2019 | Year | 01 | Month | 08 | Day |
2019 | Year | 01 | Month | 10 | Day |
2019 | Year | 03 | Month | 06 | Day |
2020 | Year | 08 | Month | 06 | Day |
2021 | Year | 06 | Month | 10 | Day |
2021 | Year | 06 | Month | 10 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050758
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