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The Effect of Erector Spinae Block on Diaphragma Movement

Primary Purpose

Laparoscopic Cholecystectomy, Acute Post-operative Pain, Respiratory Diaphragm

Status

Completed

Phase

Phase 4

Locations

Turkey

Study Type

Interventional

Intervention

Erector spinae plane block

About this trial

This is an interventional prevention trial for Laparoscopic Cholecystectomy

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Block Group

Control Group

Arm Description

Outcomes

Primary Outcome Measures

Change of Diaphragma excursion

The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period

Change in Opioid consumption

To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation

Change in postoperative pain

Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation

Secondary Outcome Measures

Full Information

NCT ID

NCT05021822

First Posted

August 13, 2021

Last Updated

August 9, 2022

Sponsor

Ufuk University

1. Study Identification

Unique Protocol Identification Number

NCT05021822

Brief Title

The Effect of Erector Spinae Block on Diaphragma Movement

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

August 2022

Overall Recruitment Status

Completed

Study Start Date

August 26, 2021 (Actual)

Primary Completion Date

September 18, 2021 (Actual)

Study Completion Date

September 18, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Ufuk University

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Laparoscopic Cholecystectomy, Acute Post-operative Pain, Respiratory Diaphragm

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

70 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Block Group

Arm Type

Active Comparator

Arm Title

Control Group

Arm Type

No Intervention

Intervention Type

Procedure

Intervention Name(s)

Erector spinae plane block

Intervention Description

Bilateral erector spinae plane block will be performed preoperatively under ultrasound guidance using 15 ml bupivacaine on each side

Primary Outcome Measure Information:

Title

Change of Diaphragma excursion

Description

The change of diaphragma excursion as measured by ultrasound in M-mode from the preoperative period to the postoperative period

Time Frame

Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation

Title

Change in Opioid consumption

Description

To assess Tramadol consumption measured in mg postoperatively in the first 12 hours after the operation

Time Frame

Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour

Title

Change in postoperative pain

Description

Postoperative pain will be measured with visual analog scale and numeric scale in the first 12 hours after the operation

Time Frame

Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ülkü C Köksoy, Ass. Prof.

Organizational Affiliation

Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

City

Ankara

ZIP/Postal Code

06520

Country

Turkey

12. IPD Sharing Statement

Plan to Share IPD

Citations:

PubMed Identifier

30288093

Citation

Petsas D, Pogiatzi V, Galatidis T, Drogouti M, Sofianou I, Michail A, Chatzis I, Donas G. Erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: a case report. J Pain Res. 2018 Sep 24;11:1983-1990. doi: 10.2147/JPR.S164489. eCollection 2018.

Results Reference

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PubMed Identifier

29913392

Citation

Tulgar S, Kapakli MS, Senturk O, Selvi O, Serifsoy TE, Ozer Z. Evaluation of ultrasound-guided erector spinae plane block for postoperative analgesia in laparoscopic cholecystectomy: A prospective, randomized, controlled clinical trial. J Clin Anesth. 2018 Sep;49:101-106. doi: 10.1016/j.jclinane.2018.06.019. Epub 2018 Jun 15.

Results Reference

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The Effect of Erector Spinae Block on Diaphragma Movement

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