Back to resultsBilateral vs. Unilateral Erector Spinae Plane Block
Primary Purpose
Postoperative Pain, Cholecystitis; Gallstone
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Bilateral ESP Block
Unilateral ESP Block
Intravenous Morphine patient controlled analgesia device
Sponsored by
About this trial
This is an interventional prevention trial for Postoperative Pain focused on measuring erector spinae plane block, postoperative pain, laparoscopic cholecystectomy
Eligibility Criteria
Inclusion Criteria:
- ASA I-II patients
- Pateints undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
- obesity (body mass index >35 kg/m2)
- infection of the skin at the site of needle puncture area
- patients with known allergies to any of the study drugs
- coagulopathy
- recent use of analgesic drugs
Sites / Locations
- Kocaeli University Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
Bilateral
Unilateral
Arm Description
Bilateral ESP block will be performed
Unilateral ESP block will be performed
Outcomes
Primary Outcome Measures
Morphine consumption
Morphine consumption will be recorded
Secondary Outcome Measures
Numeric Rating Scale
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Full Information
NCT ID
NCT03781687
First Posted
December 18, 2018
Last Updated
November 21, 2019
Sponsor
Kirsehir Ahi Evran University
1. Study Identification
Unique Protocol Identification Number
NCT03781687
Brief Title
Bilateral vs. Unilateral Erector Spinae Plane Block
Official Title
Bilateral vs. Unilateral Erector Spinae Plane Block for Laparoscopic Cholecystectomy; A Randomised Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
November 2019
Overall Recruitment Status
Completed
Study Start Date
January 2, 2019 (Actual)
Primary Completion Date
June 28, 2019 (Actual)
Study Completion Date
June 29, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kirsehir Ahi Evran 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
The importance of multimodal analgesia for postoperative pain management is well known and regional anesthesia techniques are commonly prefferred to provide better analgesia. Erector spinae plane block (ESB) is a new defined and effective regional anesthesia technique. But two injections can be unconfortable for some patients. With this study, we aimed to compare the analgesia effect of bilateral and unilateral ESP block for laparoscopic cholecystectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Cholecystitis; Gallstone
Keywords
erector spinae plane block, postoperative pain, laparoscopic cholecystectomy
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
Care ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Bilateral
Arm Type
Active Comparator
Arm Description
Bilateral ESP block will be performed
Arm Title
Unilateral
Arm Type
Active Comparator
Arm Description
Unilateral ESP block will be performed
Intervention Type
Procedure
Intervention Name(s)
Bilateral ESP Block
Intervention Description
Bilateral ESP Block will be performed at T8
Intervention Type
Procedure
Intervention Name(s)
Unilateral ESP Block
Intervention Description
Unilateral ESP Block will be performed at T8 (right side)
Intervention Type
Device
Intervention Name(s)
Intravenous Morphine patient controlled analgesia device
Intervention Description
24 hour morphine consumption will be recorded
Primary Outcome Measure Information:
Title
Morphine consumption
Description
Morphine consumption will be recorded
Time Frame
preoperative 24th hour
Secondary Outcome Measure Information:
Title
Numeric Rating Scale
Description
A NRS involves asking the patient to rate his or her pain from 0 to 10 (11 point scale) with the understanding that 0 is equal to no pain and 10 is equal to worst possible pain.
Time Frame
postoperative 24th hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA I-II patients
Pateints undergoing elective laparoscopic cholecystectomy
Exclusion Criteria:
obesity (body mass index >35 kg/m2)
infection of the skin at the site of needle puncture area
patients with known allergies to any of the study drugs
coagulopathy
recent use of analgesic drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Can Aksu
Organizational Affiliation
Kocaeli Üniversitesi Tıp Fakültesi
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kocaeli University Hospital
City
İzmit
State/Province
Kocaeli
ZIP/Postal Code
41340
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Bilateral vs. Unilateral Erector Spinae Plane Block
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