The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

Not Applicable

Completed

• Conditions: Laparoscopic Cholecystectomy; Respiratory Function; Postoperative Pain
• Interventions: Other: Control; Procedure: Bilateral Erector Spinae Block

• Registration Number: NCT03815799
• Lead Sponsor: Konya Meram State Hospital

Brief Summary

The aim of this study is to assess the effect of ultrasound guided erector spinae block in control of the postoperative pain and the respiratory functions after laparoscopic cholecystectomy.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-01-04
• Study First Submitted QC: 2019-01-22
• Study First Posted: 2019-01-24
• Study Start: 2019-03-03
• Primary Completion: 2019-09-30
• Study Completion: 2019-09-30
• Status Verified: 2020-01
• Last Update Submitted: 2020-01-13
• Last Update Posted: 2020-01-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 68

Inclusion Criteria

• American Society of Anesthesiology (ASA) physical status I-II patients who were scheduled for elective laparoscopic cholecystectomy

Exclusion Criteria

• Patients refusal
• Contraindications for regional anesthesia
• Alcohol or drug abuse
• Chronic opioid intake
• Patient with psychiatric disorders
• Use of pain killers within the 24 h before the operation
• Respiratory tract infection within the last 2 weeks
• Smoker or history of smoking
• Allergy to local anesthetics
• Respiratory and allergic diseases
• Cardiac disease associated with dyspnea

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control	Control	Routine standard perioperative and postoperative analgesic protocol will be given.
Erector Spinae Plane Block Group	Bilateral Erector Spinae Block	Procedure: In addition to routine standard perioperative and postoperative analgesic protocol participants will recieve erector spinae block under ultrasound guidence after the strict aseptic precautions.

Primary Outcome Measures

Name	Time	Method
Scoring of postoperative pain	Postoperative 24 hour	The primary outcome variable is Numeric Rating Scale (NRS) pain scores changes both at rest and movement. NRS use numbers to rate pain from 0 (no pain) to 10 (worst pain).

Secondary Outcome Measures

Name	Time	Method
Analgesic consumption	Postoperative 24 hour	Total opioid consumption after the operation
Spirometric Parameters of Respiratory Functions	Preoperative (before the surgery) and at postoperative 24th hour	Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)
Number of Adverse events	Postoperative 24 hour	Postoperative nausea and vomiting incidents at PACU and and at ward.

Trial Locations

Locations (1)

Konya Education and Training Hospital; 🇹🇷 Konya, Turkey