Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable postoperative-pain
Started Feb 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 17, 2022
CompletedFirst Submitted
Initial submission to the registry
April 5, 2022
CompletedFirst Posted
Study publicly available on registry
April 12, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 17, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
February 17, 2023
CompletedApril 18, 2022
April 1, 2022
1 year
April 5, 2022
April 11, 2022
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 24 hours
Secondary Outcomes (1)
Numeric Rating Scale (NRS)
up to 24 hours
Study Arms (2)
Transversalis Fascia Plane Block and Rectus Sheath Block Group
ACTIVE COMPARATORTransversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group.
Control Group
SHAM COMPARATORNo regional anesthesia technique will be applied to the control group.
Interventions
Transversalis fascia plane block and rectus sheath block will be administered after the surgery.
24-hour fentanyl consumption will be recorded.
Eligibility Criteria
You may qualify if:
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- American Society of Anesthesiologists (ASA) I-II
- Patients who are aged between 18-75
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Koç University Hospital
Istanbul, Zeytinburnu, 34010, Turkey (Türkiye)
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal Investigator
Study Record Dates
First Submitted
April 5, 2022
First Posted
April 12, 2022
Study Start
February 17, 2022
Primary Completion
February 17, 2023
Study Completion
February 17, 2023
Last Updated
April 18, 2022
Record last verified: 2022-04
Data Sharing
- IPD Sharing
- Will not share