Clinical trial NCT05021822: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Laparoscopic Cholecystectomy
Acute Post-operative Pain
Respiratory Diaphragm
Lead sponsor: Ufuk University
Sponsor class: OTHER
First posted: 2021-08-26
Enrollment: 70
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


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

Primary outcomes:
measure: Change of Diaphragma excursion
timeFrame: Preoperative measurement-before the erector spina plane block application and postoperative measurement- 30 minutes after extubation
measure: Change in Opioid consumption
timeFrame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
measure: Change in postoperative pain
timeFrame: Postoperative 12 hours: in the first 30 minutes after extubation, 1st hour, 6th hour and 12th hour
Secondary outcomes:
Other outcomes:
Locations:
city: Ankara
country: Turkey
facility: Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi
Study officials:
affiliation: Ufuk University Faculty of Medicine Department of Anesthesiology and Reanimation
name: Ülkü C Köksoy, Ass. Prof.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.