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

Primary Purpose

Laparoscopic Cholecystectomy, Postoperative Pain, Respiratory Function

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral Erector Spinae Block
Control
Sponsored by
Konya Meram State Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Laparoscopic Cholecystectomy focused on measuring Erector Spinae Block, Laparoscopy, Respiratory Function

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Konya Education and Training Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

Erector Spinae Plane Block Group

Control

Arm Description

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.

Routine standard perioperative and postoperative analgesic protocol will be given.

Outcomes

Primary Outcome Measures

Scoring of postoperative pain
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

Analgesic consumption
Total opioid consumption after the operation
Spirometric Parameters of Respiratory Functions
Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)
Number of Adverse events
Postoperative nausea and vomiting incidents at PACU and and at ward.

Full Information

First Posted
January 4, 2019
Last Updated
January 13, 2020
Sponsor
Konya Meram State Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03815799
Brief Title
The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Official Title
The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
January 2020
Overall Recruitment Status
Completed
Study Start Date
March 3, 2019 (Actual)
Primary Completion Date
September 30, 2019 (Actual)
Study Completion Date
September 30, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Konya Meram State Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Laparoscopic Cholecystectomy, Postoperative Pain, Respiratory Function
Keywords
Erector Spinae Block, Laparoscopy, Respiratory Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
68 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Erector Spinae Plane Block Group
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
Sham Comparator
Arm Description
Routine standard perioperative and postoperative analgesic protocol will be given.
Intervention Type
Procedure
Intervention Name(s)
Bilateral Erector Spinae Block
Intervention Description
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).
Intervention Type
Other
Intervention Name(s)
Control
Intervention Description
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 Measure Information:
Title
Scoring of postoperative pain
Description
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).
Time Frame
Postoperative 24 hour
Secondary Outcome Measure Information:
Title
Analgesic consumption
Description
Total opioid consumption after the operation
Time Frame
Postoperative 24 hour
Title
Spirometric Parameters of Respiratory Functions
Description
Respiratory functions assessed by spirometric parameters (FEV1, FVC, FEV1/FVC, and PEFR)
Time Frame
Preoperative (before the surgery) and at postoperative 24th hour
Title
Number of Adverse events
Description
Postoperative nausea and vomiting incidents at PACU and and at ward.
Time Frame
Postoperative 24 hour

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Facility Information:
Facility Name
Konya Education and Training Hospital
City
Konya
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29913392
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.
Results Reference
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PubMed Identifier
25948166
Citation
Basaran B, Basaran A, Kozanhan B, Kasdogan E, Eryilmaz MA, Ozmen S. Analgesia and respiratory function after laparoscopic cholecystectomy in patients receiving ultrasound-guided bilateral oblique subcostal transversus abdominis plane block: a randomized double-blind study. Med Sci Monit. 2015 May 7;21:1304-12. doi: 10.12659/MSM.893593.
Results Reference
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PubMed Identifier
27501016
Citation
Forero M, Adhikary SD, Lopez H, Tsui C, Chin KJ. The Erector Spinae Plane Block: A Novel Analgesic Technique in Thoracic Neuropathic Pain. Reg Anesth Pain Med. 2016 Sep-Oct;41(5):621-7. doi: 10.1097/AAP.0000000000000451.
Results Reference
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The Effect of Ultrasound-Guided Erector Spinae Block on Respiratory Function After Laparoscopic Cholecystectomy

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