UMIN-ICDS Clinical Trial

Public title

Comparative analysis of TAP block combined with NSAID administration and epidural analgesia

Acronym

CATEPI

Scientific Title

Comparative analysis of TAP block combined with NSAID administration and epidural analgesia in early postoperative period: a randomized clinical trial

Scientific Title:Acronym

CATEPI

Region

Asia(except Japan)

Condition

The study started in the beginning of January 2019 and ended in January 2021. The institutional review board approval was obtained for this study.

Classification by specialty

Medicine in general

Anesthesiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

1. Assess the effectiveness of the TAP block with intravenous administration of NSAID after laparoscopic surgery and laparotomy and compare it to the epidural anesthesia.
2. To compare the combination of TAP block with the intravenous administration of NSAID with epidural analgesia

Basic objectives2

Safety,Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

The primary outcome of the study was a comparison of an efficacy of TAP anesthesia to that of epidural anesthesia in managing the pain at 24 hrs after the laparoscopy surgery or laparotomy.

Key secondary outcomes

Secondary outcome measures included visual analog scores, satisfaction of patients and surgeons with anesthesia, hemodynamic criteria, oxygen saturation (SpO2), time of the transition of the patient from the inpatient to the ambulatory care and appearance of the adverse effects.

Study type

Interventional

Basic design

Parallel

Randomization

Randomized

Randomization unit

Individual

Blinding

Open -no one is blinded

Control

Active

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

No. of arms

2

Purpose of intervention

Treatment

Type of intervention

Medicine	Maneuver	Other

Interventions/Control_1

1) the main group in which the TAP block was performed in early postoperative period (during the first 24 hrs). In addition, the patients of this group also received the intravenous administration of the NSAID ketonal, total volume of 8 ml, 4 times/24 hrs. Referred as "TAP+NSAID".

Interventions/Control_2

2) the control group in which the epidural analgesia was used. As a local anesthetic, the 0.25% solution of bupivacaine was used. The 80 to 120 mg of bupivacaine solution were administered as a bolus through a catheter into the epidural space at a dose of 80 to 120 mg. Then, after about 3-6 hours, a bolus of 80-100 mg of bupivacaine solution was administered during the day. The daily dose of bupivacaine did not exceed 400 mg. Referred as "Epidural".

Interventions/Control_3

Interventions/Control_4

Interventions/Control_5

Interventions/Control_6

Interventions/Control_7

Interventions/Control_8

Interventions/Control_9

Interventions/Control_10

Age-lower limit

18

years-old

<

Age-upper limit

75

years-old

>

Gender

Male and Female

Key inclusion criteria

1. adults
2. aged 18 to 75
3. male and female
4. ASA physical status of either I or II
5. written consent

Key exclusion criteria

1. children
2. ASA status III, IV, V, VI
3. Refusal to sign the consent
4. dementia

Target sample size

120

Name of lead principal investigator

1st name	Rinat
Middle name
Last name	Ashzhanov

Organization

Pavlodar Branch of NCJSC "Semey Medical University"

Division name

Department of Emergency Medicine

Zip code

140000

Address

Toraigyrov str. 72/1

TEL

+77051625647

Email

mamyrova26@gmail.com

Name of contact person

1st name	Rinat
Middle name
Last name	Ashzhanov

Organization

Pavlodar Branch of NCJSC "Semey Medical University"

Division name

Department of Emergency Medicine

Zip code

140000

Address

Toraigyrov str. 72/1

TEL

+7(7182)55-28-54

Homepage URL

Email

mamyrova26@gmail.com

Institute

Pavlodar Branch of NCJSC "Semey Medical University"

Institute

Department

Personal name

Organization

The authors reported there is no funding associated with the work featured in this study

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

Name of secondary funder(s)

Organization

Ethics Committee of NCJSC Semey Medical University, created in accordance with the order of chancellor #45 from 17.05.2006

Address

071400, Abai Region, Semey city, 103 Abay St.

Tel

+77751681882

Email

smu@smu.edu.kz

Secondary IDs

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

Institutions

Date of disclosure of the study information

2023

Year

04

Month

13

Day

URL releasing protocol

Publication of results

Unpublished

URL related to results and publications

Number of participants that the trial has enrolled

127

Results

Results date posted

Results Delayed

Results Delay Reason

Date of the first journal publication of results

Baseline Characteristics

Participant flow

Adverse events

Outcome measures

Plan to share IPD

IPD sharing Plan description

Recruitment status

No longer recruiting

Date of protocol fixation

2019

Year

01

Month

09

Day

Date of IRB

2019

Year

01

Month

10

Day

Anticipated trial start date

2019

Year

01

Month

16

Day

Last follow-up date

2022

Year

06

Month

22

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

Registered date

2023

Year

04

Month

12

Day

Last modified on

2023

Year

04

Month

12

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000057924