Back to resultsTransversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
Primary Purpose
Postoperative Pain
Status
Recruiting
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
Transversalis fascia plane block and rectus sheath block
Intravenous fentanyl patient control device
Sponsored by
About this trial
This is an interventional treatment trial for Postoperative Pain
Eligibility Criteria
Inclusion Criteria:
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- American Society of Anesthesiologists (ASA) I-II
- Patients who are aged between 18-75
Exclusion Criteria:
- Skin infection at the block area
- Coagulation disorder and using anticoagulant drugs
- End-stage organ and system failure
- Severe pulmonary and/or cardiovascular problems
- Substance addiction or known psychiatric or mental problems
- Chronic painkiller usage
Sites / Locations
- Koç University HospitalRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Sham Comparator
Arm Label
Transversalis Fascia Plane Block and Rectus Sheath Block Group
Control Group
Arm Description
Transversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group.
No regional anesthesia technique will be applied to the control group.
Outcomes
Primary Outcome Measures
Total opioid consumption retrieved from patient records
the amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.
Secondary Outcome Measures
Numeric Rating Scale (NRS)
Pain of patients will be evaluated and recorded according to NRS. A NRS requires the patient to rate their pain on a defined scale between 0 and10 (0 is no pain and 10 is the worst pain)
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05324215
Brief Title
Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
Official Title
Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Recruiting
Study Start Date
February 17, 2022 (Actual)
Primary Completion Date
February 17, 2023 (Anticipated)
Study Completion Date
February 17, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Koc University 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
Transversalis fascia plane block (TFPB) is a relatively new, easy-to-apply and safe regional anesthesia technique used to provide postoperative analgesia in various surgeries. It has been shown that TFPB and rectus sheath block (RSB) administration reduces opioid consumption and related side effects in patients undergoing surgery with general anesthesia. To our knowledge, there is no study examining TFPB in donor nephrectomy.
The investigators aimed to prospectively examine the effect of TFPB and RSB on opioid consumption in postoperative period on donors who will undergo laparoscopic nephrectomy in renal transplantation surgery.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
50 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Transversalis Fascia Plane Block and Rectus Sheath Block Group
Arm Type
Active Comparator
Arm Description
Transversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group.
Arm Title
Control Group
Arm Type
Sham Comparator
Arm Description
No regional anesthesia technique will be applied to the control group.
Intervention Type
Procedure
Intervention Name(s)
Transversalis fascia plane block and rectus sheath block
Intervention Description
Transversalis fascia plane block and rectus sheath block will be administered after the surgery.
Intervention Type
Device
Intervention Name(s)
Intravenous fentanyl patient control device
Intervention Description
24-hour fentanyl consumption will be recorded.
Primary Outcome Measure Information:
Title
Total opioid consumption retrieved from patient records
Description
the amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.
Time Frame
up to 24 hours
Secondary Outcome Measure Information:
Title
Numeric Rating Scale (NRS)
Description
Pain of patients will be evaluated and recorded according to NRS. A NRS requires the patient to rate their pain on a defined scale between 0 and10 (0 is no pain and 10 is the worst pain)
Time Frame
up to 24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Donor patients scheduled for elective nephrectomy in renal transplantation surgery
American Society of Anesthesiologists (ASA) I-II
Patients who are aged between 18-75
Exclusion Criteria:
Skin infection at the block area
Coagulation disorder and using anticoagulant drugs
End-stage organ and system failure
Severe pulmonary and/or cardiovascular problems
Substance addiction or known psychiatric or mental problems
Chronic painkiller usage
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Özlem Özkalaycı, MD
Phone
+90 850 250 8250
Ext
29805
Email
oozkalayci@kuh.ku.edu.tr
Facility Information:
Facility Name
Koç University Hospital
City
Istanbul
State/Province
Zeytinburnu
ZIP/Postal Code
34010
Country
Turkey
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Özlem Özkalaycı, Md.
Phone
+908502508250
Ext
29805
Email
oozkalayci@kuh.ku.edu.tr
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
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