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

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ClinicalTrials.gov Identifier: NCT03815799
Recruitment Status : Recruiting
First Posted : January 24, 2019
Last Update Posted : October 1, 2019
Sponsor:
Information provided by (Responsible Party):
Asst. Prof. Munıse Yıldız M.D., Konya Training and Research 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.

Condition or disease Intervention/treatment Phase
Laparoscopic Cholecystectomy Postoperative Pain Respiratory Function Procedure: Bilateral Erector Spinae Block Other: Control Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 68 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Actual Study Start Date : March 3, 2019
Actual Primary Completion Date : September 30, 2019
Estimated Study Completion Date : September 30, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Arm Intervention/treatment
Experimental: Erector Spinae Plane Block Group

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.

Procedure: Bilateral Erector Spinae Block
A linear ultrasound transducer will be place in a longitudinal parasagittal orientation about 3 cm lateral to spinous process. 40 ml bupivacaine/lidocaine mixture will be injected into the fascial plane on the deep aspect of erector spinae muscle. Standard perioperative and postoperative analgesia protocol will be given and postoperative pain levels will be determined by Numerical rating scale (NRS).

Sham Comparator: Control
Routine standard perioperative and postoperative analgesic protocol will be given.
Other: Control
Standard perioperative and postoperative analgesia protocol will be given consisting of paracetamol 1 gr IV and tenoxicam 20 mg IV initiated after induction of anesthesia. At the end of the operation patients will receive meperidine 0.5 mg/kg IV before extubation. Postoperative pain levels will be determined by Numeric Rating Scale (NRS) system, 20 minutes intervals in the first hour and at 2th, 6th, 12th and 24 th hour. For the first hour in the postoperative care unit, tramadol 50 mg IV will be given for rescue analgesia with minimum 20 minutes between doses, in patients showing a NRS ≥ 4. Paracetamol 1 g / 12 hour will be given during ward follow-up. In the ward in patients showing a NRS ≥ 4 tramadol 50 mg IV will be given for analgesia.




Primary Outcome Measures :
  1. Scoring of postoperative pain [ Time Frame: 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 :
  1. Analgesic consumption [ Time Frame: Postoperative 24 hour ]
    Total opioid consumption after the operation

  2. Spirometric Parameters of Respiratory Functions [ Time Frame: Preoperative (before the surgery) and at postoperative 24th hour ]
    Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)

  3. Number of Adverse events [ Time Frame: Postoperative 24 hour ]
    Postoperative nausea and vomiting incidents at PACU and and at ward.



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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03815799


Contacts
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Contact: Betul Kozanhan, Ass. Prof. +905055044808 betulkozanhan@gmail.com

Locations
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Turkey
Konya Education and Training Hospital Recruiting
Konya, Turkey
Contact: munise yıldız, M.D.       drmunise@hotmail.com   
Sponsors and Collaborators
Konya Training and Research Hospital

Publications:
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Responsible Party: Asst. Prof. Munıse Yıldız M.D., Ass.Prof., Konya Training and Research Hospital
ClinicalTrials.gov Identifier: NCT03815799     History of Changes
Other Study ID Numbers: ESP-RF
First Posted: January 24, 2019    Key Record Dates
Last Update Posted: October 1, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Asst. Prof. Munıse Yıldız M.D., Konya Training and Research Hospital:
Erector Spinae Block
Laparoscopy
Respiratory Function
Additional relevant MeSH terms:
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Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms