The Effect of Erector Spinae Block on Diaphragma Movement

August 9, 2022 updated by: Ülkü Ceren Köksoy, Ufuk University

The Effect of Erector Spinae Plane Block on Diaphragma Movement in Laparoscopic Cholecystectomies

Laparoscopic cholecystectomy surgeries cause moderate/severe pain and thus can result in shallow breathing, atelectasis and increased opioid consumption in the early postoperative period which in turn cause a longer hospital stay. Erector spinae plane block has been shown to decrease lower thoracic pain after laparoscopic cholecystectomy surgeries. This study aims to investigate the effect of erector spinae plane block on opioid consumption and diaphragma movement after laparoscopic cholecystectomy surgeries.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Phase 4

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
      • Ankara, Turkey, 06520
        • Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Ages between 18 and 65
  • Patients in American Society of Anesthesiologists Classification I or II
  • Elective laparoscopic cholecystectomy surgery performed under general anesthesia

Exclusion Criteria:

  • Patient refusal
  • Patients who can not provide informed consent or with a known psychiatric disease
  • Patients with a known allergy to study drugs
  • Patients using anticoagulants and corticosteroids
  • Patients with diaphragma hernia, chronic obstructive pulmonary disease, lung cancer
  • Patients who are not able to use a patient controlled analgesia device

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: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control Group
Active Comparator: Block Group
Procedure: Erector spinae plane block
Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change of Diaphragma excursion
Time Frame: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation
The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period
Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation
Change in Opioid consumption
Time Frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation
Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Change in postoperative pain
Time Frame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation
Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour

Collaborators and Investigators

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

Sponsor

Ufuk University

Investigators

  • Principal Investigator: Ülkü C Köksoy, Ass. Prof., Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

August 26, 2021

Primary Completion (Actual)

September 18, 2021

Study Completion (Actual)

September 18, 2021

Study Registration Dates

First Submitted

August 13, 2021

First Submitted That Met QC Criteria

August 22, 2021

First Posted (Actual)

August 26, 2021

Study Record Updates

Last Update Posted (Actual)

August 10, 2022

Last Update Submitted That Met QC Criteria

August 9, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2021-03

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

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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