The Effect of Erector Spinae Block on Diaphragma Movement

Laparoscopic Cholecystectomy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05021822
• Other study ID #: 2021-03
• Status: Completed
• Phase: Phase 4
• Start date: August 26, 2021
• Est. completion date: September 18, 2021

Study information

• Verified date: August 2022
• Source: Ufuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 70
• Est. completion date: September 18, 2021
• Est. primary completion date: September 18, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Acute Post-operative Pain
• Laparoscopic Cholecystectomy
• Pain, Postoperative
• Respiratory Diaphragm

Intervention

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

Locations

Country	Name	City	State
Turkey	Ufuk Üniversitesi Dr. Ridvan Ege Hastanesi	Ankara

Sponsors (1)

Lead Sponsor	Collaborator
Ufuk University

Country where clinical trial is conducted

Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change of Diaphragma excursion	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
Primary	Change in Opioid consumption	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
Primary	Change in postoperative pain	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