The Effect of Erector Spinae Block on Diaphragma Movement

NCT ID: NCT05021822

Last Updated: 2022-08-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

70 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-26

Study Completion Date

2021-09-18

Brief Summary

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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.

Detailed Description

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Conditions

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Laparoscopic Cholecystectomy Acute Post-operative Pain Respiratory Diaphragm

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

Study Groups

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Block Group

Group Type ACTIVE_COMPARATOR

Erector spinae plane block

Intervention Type PROCEDURE

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

Control Group

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Erector spinae plane block

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

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Ufuk University

OTHER

Sponsor Role lead

Responsible Party

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Ülkü Ceren Köksoy

Associate Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Ülkü C Köksoy, Ass. Prof.

Role: PRINCIPAL_INVESTIGATOR

Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation

Locations

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Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi

Ankara, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

References

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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.

Reference Type BACKGROUND
PMID: 30288093 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 29913392 (View on PubMed)

Other Identifiers

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2021-03

Identifier Type: -

Identifier Source: org_study_id

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