The Effect of Erector Spinae Block on Diaphragma Movement

Phase 4

Completed

• Conditions: Acute Post-operative Pain; Laparoscopic Cholecystectomy; Respiratory Diaphragm
• Interventions: Procedure: Erector spinae plane block

• Registration Number: NCT05021822
• Lead Sponsor: Ufuk University

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-08-13
• Study First Submitted QC: 2021-08-22
• Study Start: 2021-08-26
• Study First Posted: 2021-08-26
• Primary Completion: 2021-09-18
• Study Completion: 2021-09-18
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-09
• Last Update Posted: 2022-08-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Block Group	Erector spinae plane block	-

Primary Outcome Measures

Name	Time	Method
Change in Opioid consumption	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
Change of Diaphragma excursion	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
Change in postoperative pain	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

Trial Locations

Locations (1)

Ufuk Üniversitesi Dr. Rıdvan Ege Hastanesi; 🇹🇷 Ankara, Turkey