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Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

Primary Purpose

Postoperative Pain

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae plane block
Intravenous morphine patient controlled analgesia device
Sponsored by
Kirsehir Ahi Evran University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain focused on measuring erector spinae plane block, laparoscopic cholecystectomy, postoperative pain

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kocaeli University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Sham Comparator

Arm Label

Block group

control group

Arm Description

Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively

An intravenous patient controlled analgesia device will be given to the patients postoperatively

Outcomes

Primary Outcome Measures

24h morphine consumption
morphine consumptions for both group will be recorded

Secondary Outcome Measures

Postoperative nausea and vomiting
PONV after surgery was questioned
Pain
Numeric rating scales were recorded

Full Information

First Posted
January 29, 2018
Last Updated
June 13, 2018
Sponsor
Kirsehir Ahi Evran University
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1. Study Identification

Unique Protocol Identification Number
NCT03420703
Brief Title
Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy
Official Title
The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study
Study Type
Interventional

2. Study Status

Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
February 24, 2018 (Actual)
Primary Completion Date
April 18, 2018 (Actual)
Study Completion Date
April 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
erector spinae plane block, laparoscopic cholecystectomy, postoperative pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
46 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Block group
Arm Type
Active Comparator
Arm Description
Erector espine plane block will be administrated to this group. An intravenous patient controlled analgesia device will be given to the patients postoperatively
Arm Title
control group
Arm Type
Sham Comparator
Arm Description
An intravenous patient controlled analgesia device will be given to the patients postoperatively
Intervention Type
Other
Intervention Name(s)
erector spinae plane block
Intervention Description
ultrasound guided erector spinae plane block will be administered to this group.
Intervention Type
Device
Intervention Name(s)
Intravenous morphine patient controlled analgesia device
Intervention Description
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Primary Outcome Measure Information:
Title
24h morphine consumption
Description
morphine consumptions for both group will be recorded
Time Frame
for postoperative 24 hour
Secondary Outcome Measure Information:
Title
Postoperative nausea and vomiting
Description
PONV after surgery was questioned
Time Frame
24 hour
Title
Pain
Description
Numeric rating scales were recorded
Time Frame
24h

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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
Facility Information:
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41340
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

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