Erector Spinae Plane Block for Postoperative Analgesia fo... | NCT03420703

Studies
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

NCT03420703

Sponsor

Kocaeli University

Status

Completed

Last Update Posted

Jun 15, 2018Actual

Enrollment

46Actual

Phase

Not Applicable

Conditions

Postoperative Pain

Interventions

erector spinae plane block
Intravenous morphine patient controlled analgesia device

Countries

Turkey (Türkiye)

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2018

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2018Actual

Primary Completion Date

Apr 18, 2018Actual

Completion Date

Apr 18, 2018Actual

First Submitted Date

Jan 29, 2018

First Submission Date that Met QC Criteria

Jan 29, 2018

First Posted Date

Feb 5, 2018Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 13, 2018

Last Update Posted Date

Jun 15, 2018Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented application of this blockade into practice at the clinic. Main purpose of this study is to evaluate the analgesic effect of ultrasound guided erector spinae block in laparoscopic cholecystectomy.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

46Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Block group	Active Comparator	Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively	Other: erector spinae plane block Device: Intravenous morphine patient controlled analgesia device
control group	Sham Comparator	An intravenous patient controlled analgesia device will be given to the patients postoperatively	Device: Intravenous morphine patient controlled analgesia device

Interventions

Name	Type	Description	Arm Group Labels	Other Names
erector spinae plane block	Other	ultrasound guided erector spinae plane block will be administered to this group.	Block group

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
24h morphine consumption	morphine consumptions for both group will be recorded	for postoperative 24 hour

Secondary Outcomes

Measure	Description	Time Frame
Postoperative nausea and vomiting	PONV after surgery was questioned	24 hour
Pain	Numeric rating scales were recorded	24h

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

25 - 75 years of age
ASA I - II
Undergoing elective laparoscopic cholecystectomy

Exclusion Criteria:

obesity
ASA III - IV
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
recent use of analgesic drugs

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kocaeli University Hospital		İzmit	Kocaeli	41340	Turkey (Türkiye)

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D010149	Pain, Postoperative

Ancestor Terms

ID	Term
D011183	Postoperative Complications
D010335	Pathologic Processes
D013568	Pathological Conditions, Signs and Symptoms
D010146	Pain

Browse Leaves

Not provided

Browse Branches

Not provided