NCT04130945

Brief Summary

Use of erector spina plane (ESP) block for postoperative analgesia is continuously increasing. However, few studies have investigated intraoperative effects of ESP block. The investigators aim to study the effects of ESP block in terms of cost-effectiveness, consumption of inhalation agents and opioids in perioperative and postoperative period.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
81

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Sep 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 11, 2019

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

October 16, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

October 18, 2019

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 30, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2019

Completed
Last Updated

July 1, 2020

Status Verified

June 1, 2020

Enrollment Period

3 months

First QC Date

October 16, 2019

Last Update Submit

June 30, 2020

Conditions

Cost Effectiveness

Outcome Measures

Primary Outcomes (1)

  • the formula of consumption of inhaled agent

    the formula which includes fresh gas flow, valume of inhaled agent vapor, sevoflurane concentration

    30 minute after the operation

Study Arms (2)

group 1

ACTIVE COMPARATOR

patients with erector spine plane block

Other: erector spina plane block, cost analysis

group 2

NO INTERVENTION

patients without erector spine plane block

Interventions

erector spina plane block, cost analysisOTHER

in preopererative period, ESP block is going to utilise for postoperative analgesia for patients who undergo laparoscopic procedure and cost analysis will make after the end of 24 hour of operation

group 1

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • American Society of Anesthesiologist (ASA) physical status I-II,
  • ages 18-75 years,
  • undergoing laparoscopic cholecystectomy

You may not qualify if:

  • Patients with cardiac, endocrinological, neurological diseases,
  • patients with coagulation disorders
  • allergy to local anesthetics
  • Operations that started as laparoscopy but transitioned to open surgery for a surgical reason

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Kırıkkale Univercity Faculty of Medicine Hospital

Kırıkkale, 71450, Turkey (Türkiye)

Location

MeSH Terms

Interventions

Costs and Cost Analysis

Intervention Hierarchy (Ancestors)

EconomicsHealth Care Economics and Organizations

Study Officials

  • Kevser Peker

    Kırıkkale University Faculty of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
SCREENING
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
assitant professor

Study Record Dates

First Submitted

October 16, 2019

First Posted

October 18, 2019

Study Start

September 11, 2019

Primary Completion

November 30, 2019

Study Completion

November 30, 2019

Last Updated

July 1, 2020

Record last verified: 2020-06

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)