Erector Spinae Plane Block for Postoperative Analgesia for Laparoscopic Cholecystectomy

June 13, 2018 updated by: Can AKSU, Kocaeli University

The Effect of Erector Spinae Plane Block on Postoperative Pain Following Laparoscopic Cholecystectomy: A Randomized Controlled Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

46

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Turkey
    • Kocaeli
      • İzmit, Kocaeli, Turkey, 41340
        • Kocaeli University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Block group
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
ultrasound guided erector spinae plane block will be administered to this group.
Device: Intravenous morphine patient controlled analgesia device
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded
Sham Comparator: control group
An intravenous patient controlled analgesia device will be given to the patients postoperatively
Device: Intravenous morphine patient controlled analgesia device
Intravenous morphine patient controlled analgesia device will be given to the patients postoperatively and 24 hour morphine consumption will be recorded

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Kocaeli University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 24, 2018

Primary Completion (Actual)

April 18, 2018

Study Completion (Actual)

April 18, 2018

Study Registration Dates

First Submitted

January 29, 2018

First Submitted That Met QC Criteria

January 29, 2018

First Posted (Actual)

February 5, 2018

Study Record Updates

Last Update Posted (Actual)

June 15, 2018

Last Update Submitted That Met QC Criteria

June 13, 2018

Last Verified

June 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2017-349

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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