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Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy

Primary Purpose

Postoperative Pain, Anesthesia, Local

Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
erector spinae plane block
quadratus lumborum block
Sponsored by
Maltepe University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Elective laparoscopic Cholecystectomy, ASA status 1-2

Exclusion Criteria:

  • Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders

Sites / Locations

  • Antalya research hospital
  • Maltepe University faculty of medicine
  • Cigli Educatinal Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

ESP Block

QLB block

Arm Description

Outcomes

Primary Outcome Measures

analgesic consumption
opioid consumption in Patient Controlled Analgesia device

Secondary Outcome Measures

NRS scores
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").

Full Information

First Posted
March 8, 2019
Last Updated
May 31, 2019
Sponsor
Maltepe University
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1. Study Identification

Unique Protocol Identification Number
NCT03869801
Brief Title
Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy
Official Title
Comparison of Ultrasound Guided Bilateral Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoscopic Cholecystectomy
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 15, 2019 (Actual)
Primary Completion Date
May 31, 2019 (Actual)
Study Completion Date
May 31, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maltepe University

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
Erector Spinae Plane Block is a newly defined regional anesthesia technique. Its use for many indications has been identified by case reports in the literature. As the investigators have considered that erector spinae plane block could be efficacious for providing postoperative analgesia in laparoscopic cholecystectomy, the investigators have implemented the application of this blockade into practice at the clinic.Quadratus Lumborum block (QLB) type 2 is another regional anesthesia technic used for postoperative analgesia in laparoscopic cholecystectomy. Main purpose of this study is to compare the analgesic effect of ultrasound-guided erector spinae block and QLB in laparoscopic cholecystectomy.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Anesthesia, Local

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
80 (Actual)

8. Arms, Groups, and Interventions

Arm Title
ESP Block
Arm Type
Active Comparator
Arm Title
QLB block
Arm Type
Active Comparator
Intervention Type
Procedure
Intervention Name(s)
erector spinae plane block
Other Intervention Name(s)
Standard Pain Followup and Monitorization
Intervention Description
Ultrasound-guided bilateral Erector spinae plane (ESP) block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block
Other Intervention Name(s)
Standard Pain Followup and Monitorization
Intervention Description
Ultrasound-guided bilateral Quadratus lumborum (QLB) type 2 block performed before the surgery. Perioperative and postoperative routine analgesic protocol will be performed (consist of intravenous analgesics and intravenous patient-controlled analgesia) with no additional intervention (block) Standard Pain Followup and Monitorization will be performed.
Primary Outcome Measure Information:
Title
analgesic consumption
Description
opioid consumption in Patient Controlled Analgesia device
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
NRS scores
Description
Changes in Numeric Rating Scale (NRS) at rest and on movement will be recorded at intervals. NRS is a unidimensional measure of pain intensity in adults. The NRS is a segmented numeric version of the visual analog scale (VAS) in which a respondent selects a whole number (0-10 integers) that best reflects the intensity of his/her pain. The 11-point numeric scale ranges from '0' representing one pain extreme (e.g. "no pain") to '10' representing the other pain extreme (e.g. "pain as bad as you can imagine" or "worst pain imaginable").
Time Frame
24 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Elective laparoscopic Cholecystectomy, ASA status 1-2 Exclusion Criteria: Patient refusal Contraindications to regional anesthesia Known allergy to local anesthetics Bleeding diathesis Use of any anti-coagulants Inability to provide informed consent Severe kidney or liver disease Inability to operate PCA system Patient with psychiatric disorders
Facility Information:
Facility Name
Antalya research hospital
City
Antalya
ZIP/Postal Code
07084
Country
Turkey
Facility Name
Maltepe University faculty of medicine
City
Istanbul
ZIP/Postal Code
34090
Country
Turkey
Facility Name
Cigli Educatinal Hospital
City
İzmir
ZIP/Postal Code
35085
Country
Turkey

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
29929169
Citation
Okmen K, Metin Okmen B, Topal S. Ultrasound-guided posterior quadratus lumborum block for postoperative pain after laparoscopic cholecystectomy: A randomized controlled double blind study. J Clin Anesth. 2018 Sep;49:112-117. doi: 10.1016/j.jclinane.2018.06.027. Epub 2018 Jun 18.
Results Reference
result
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
result

Learn more about this trial

Comparion of Erector Spinae Plane Block and Quadratus Lumborum Block in Laparoskopic Cholecystectomy

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