Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block
Primary Purpose
Postoperative Pain
Status
Unknown status
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
quadratus lumborum block
Transversus abdominis plan block
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain focused on measuring postoperative pain, Laparoscopic cholecystectomy, Quadratus lumborum block, transversus abdominis plan block
Eligibility Criteria
Inclusion Criteria:
- ASA 1-2-3
- elective Laparoscopic cholecystectomy
- 19-65 years
- Written informed consent
Exclusion Criteria:
- Patient refusal Local infection at the site of injection
- Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system
- Inability to use intravenous patient controlled analgesia
Sites / Locations
- Kecioren ETHRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
QLB: Quadratus lumborum block
TAP: transversus abdominis plan block
Arm Description
QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL) patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %
TAP: Transversus abdominis plane block (TAP) patients will receive a bilateral TAP block using Bupivicaine 0.25%
Outcomes
Primary Outcome Measures
Total cumulative morphine consumption
Total cumulative morphine dose in mg used in the first 24 hours after surgery
Secondary Outcome Measures
Severity of postoperative pain via visual analogue pain scale (VAS)
VAS range from 0 for no pain to 10 for worst pain imaginable
Nausea or vomiting
0 = No Nausea
= Mild Nausea.
= Moderate 3 = Severe Nausea or Vomiting
Full Information
NCT ID
NCT03112915
First Posted
February 27, 2017
Last Updated
September 24, 2017
Sponsor
Kecioren Education and Training Hospital
1. Study Identification
Unique Protocol Identification Number
NCT03112915
Brief Title
Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block
Official Title
Comparison of Quadratus Lumborum Block and Transversus Abdominis Plane Block for Postoperative Pain Control After Laparoscopic Cholecystectomy
Study Type
Interventional
2. Study Status
Record Verification Date
September 2017
Overall Recruitment Status
Unknown status
Study Start Date
April 20, 2017 (Actual)
Primary Completion Date
August 1, 2018 (Anticipated)
Study Completion Date
September 12, 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kecioren Education and Training 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
In this study, investigators aimed to compare the Quadratus Lumborum Block and the Transversus Abdominis Plan Block for postoperative pain control after laparoscopic cholecystectomy
Detailed Description
After ethical committee approval, informed written consent will be obtained from all patients.
A Sample size of 60 patients (30 per group) was calculated based on 15% reduction in morphine consumption with 0.05% significance and a power of 0.8.
Consenting patients scheduled to have elective laparoscopic cholecystectomy under general anesthesia will be randomized to receive bilateral QLB or TAP before the surgery. The dose of local anesthetic in both groups will be 20 ml 0.25% Bupivacaine. Allocation to either group will be done using permuted block randomization method.
Patients will be taken to the block room 1 hour before surgery. ECG, NIBP and SpO2 monitor will be done. The IV access route will be provided. The patient will be given 0.03 mg / kg IV midazolam for routine premedication. Block will be applied by a blind anesthetist to the other data of the study. Under ultrasound guidance a 22 Gauge Sonoplex needle will be used for both techniques. The calculated dose of local anesthetic will be injected bilaterally with intermittent aspiration. The spread of injectate will be seed on ultrasound.
The procedure time for both blocks will be recorded and 30 minutes after the procedure is completed, and the patient will be taken to the operation room. General anesthesia will be applied to the patient in the operation procedure in the standard procedure. Intraoperative heart rate and / or mean arterial pressure is increased to 20% of the basal value and 0.5 mcg / kg IV fentanyl will be added. 30 minutes before the end of operation, 1 mg IV paracetamol and NSAID (dexketoprofen) 50 mg IV will be administered to the patient before extubation. The patient will be infected with IV PCA in the morphine. PC 1 mg IV bolus dose will be adjusted to 10 minutes of locked-out period. In the postoperative period, 4 * 1 gr / 24 h IV paracetamol will be given to each patient.
All patients will be assessed postoperatively by a blinded investigator: in the post-anesthesia care unit and at 0, 2, 4, 6, 12 and 24 h postoperatively.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
Keywords
postoperative pain, Laparoscopic cholecystectomy, Quadratus lumborum block, transversus abdominis plan block
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Double-blind randomized controlled trail
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Double-blind randomized controlled trail
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
QLB: Quadratus lumborum block
Arm Type
Active Comparator
Arm Description
QLB: Quadratus lumborum block :Quadratus Lumborum block group (QL)
patients will receive a bilateral Quadratus Lumborum block using Bupivicaine 0.25 %
Arm Title
TAP: transversus abdominis plan block
Arm Type
Active Comparator
Arm Description
TAP: Transversus abdominis plane block (TAP)
patients will receive a bilateral TAP block using Bupivicaine 0.25%
Intervention Type
Procedure
Intervention Name(s)
quadratus lumborum block
Other Intervention Name(s)
QLB
Intervention Description
QLB: Quadratus lumborum block : 20 mL of 0.25% bupivacaine will be administered between the quadratus lumborum and the psoas major muscle bilaterally in the lateral decubitus position
Intervention Type
Procedure
Intervention Name(s)
Transversus abdominis plan block
Other Intervention Name(s)
TAP block
Intervention Description
TAP: transversus abdominis plan block: 20 mL of 0.25% bupivacaine will be administered between the internal oblique muscle and the transversus abdominis muscle bilaterally in the supine position
Primary Outcome Measure Information:
Title
Total cumulative morphine consumption
Description
Total cumulative morphine dose in mg used in the first 24 hours after surgery
Time Frame
24 hour
Secondary Outcome Measure Information:
Title
Severity of postoperative pain via visual analogue pain scale (VAS)
Description
VAS range from 0 for no pain to 10 for worst pain imaginable
Time Frame
24 hour
Title
Nausea or vomiting
Description
0 = No Nausea
= Mild Nausea.
= Moderate 3 = Severe Nausea or Vomiting
Time Frame
24 hour
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
ASA 1-2-3
elective Laparoscopic cholecystectomy
19-65 years
Written informed consent
Exclusion Criteria:
Patient refusal Local infection at the site of injection
Allergy to study medications Sepsis Anatomic abnormalities Systemic anticoagulation or coagulopathy - Inability to comprehend or participate in pain scoring system
Inability to use intravenous patient controlled analgesia
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
merve kacan
Phone
+90 05532529902
Email
drmervekacan@gmail.com
Facility Information:
Facility Name
Kecioren ETH
City
Ankara
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
merve kacan
Phone
+9005532529902
Email
drmervekacan@gmail.com
First Name & Middle Initial & Last Name & Degree
handan gulec
First Name & Middle Initial & Last Name & Degree
berrin kosar
First Name & Middle Initial & Last Name & Degree
eyup horasanli
First Name & Middle Initial & Last Name & Degree
merve kacan
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Links:
URL
https://www.ncbi.nlm.nih.gov/pubmed/28154824
Description
Related Info
URL
https://www.ncbi.nlm.nih.gov/pubmed/27755488
Description
Related Info
Learn more about this trial
Comparison of the Quadratus Lumborum Block With the Transversus Abdominis Plan Block
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