UMIN-CTR Clinical Trial

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