UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000044487
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

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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 or person

Institute

mmu, anaesthesia

Institute

Department

Personal name



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

Value
https://center6.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