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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000044487
Receipt No. 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

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Basic information
Public title EVALUATION OF SAFETY AND EFFICACY OF PATIENT CONTROLLED EPIDURAL ANALGESIA VERSUS CONVENTIONAL EPIDURAL ANALGESIA
Acronym PCEA VS CONVENTIONAL EPIDURAL ANALGESIA
Scientific Title SAFETY AND EFFICACY OF PATIENT CONTROLLED EPIDURAL ANALGESIA VERSUS CONVENTIONAL EPIDURAL ANALGESIA
Scientific Title:Acronym SAFETY AND EFFICACY OF PCEA
Region
Asia(except Japan)

Condition
Condition IN ORTHOPEDIC LOWER LIMB SURGERIES
Classification by specialty
Anesthesiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 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.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2
Developmental phase Not applicable

Assessment
Primary outcomes Hemodynamic parameters

Quality of postoperative analgesia
Key secondary outcomes Post operative adverse effect

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -participants are blinded
Control Active
Stratification NO
Dynamic allocation NO
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Pseudo-randomization

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 patient controlled epidural analgesia
Interventions/Control_2 Intermittent epidural bolus
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
65 years-old >=
Gender Male and Female
Key inclusion criteria 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
Key exclusion criteria 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
Target sample size 60

Research contact person
Name of lead principal investigator
1st name venu
Middle name gopal
Last name tatineni
Organization maharishi markandeshwar university
Division name anaesthesia
Zip code 133207
Address mullana
TEL 9642222188
Email drtatinenivenu@gmail.com

Public contact
Name of contact person
1st name babita
Middle name
Last name ramdev
Organization maharishi markandeshwar university
Division name anaesthesia
Zip code 133207
Address department of anaesthesia , mullana
TEL 9530581040
Homepage URL
Email drtatinenivenu@gmail.com

Sponsor
Institute mmu, anaesthesia
Institute
Department

Funding Source
Organization maharishi markandeshwar university
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization maharishi markandeshwar university
Address mmu, mullana
Tel 9555522188
Email hod.anaesthesia@mmumullana.org

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2021 Year 06 Month 10 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled 60
Results 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
Results date posted
2021 Year 06 Month 09 Day
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events Side effects such as nausea, vomiting, hypotension, bradycardia, pruritus, retention of urine, respiratory depression were observed, documented and treated
Outcome measures 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.
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Completed
Date of protocol fixation
2019 Year 01 Month 08 Day
Date of IRB
2019 Year 01 Month 10 Day
Anticipated trial start date
2019 Year 03 Month 06 Day
Last follow-up date
2020 Year 08 Month 06 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2021 Year 06 Month 10 Day
Last modified on
2021 Year 06 Month 10 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000050758

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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