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

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.

Study Overview

• Status: Recruiting
• Conditions: Postoperative Pain
• Intervention / Treatment: Procedure: Transversalis fascia plane block and rectus sheath block; Device: Intravenous fentanyl patient control device

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Özlem Özkalaycı, MD; Phone Number: 29805 +90 850 250 8250; Email: oozkalayci@kuh.ku.edu.tr

Study Locations

• Turkey
  • Zeytinburnu
    • Istanbul, Zeytinburnu, Turkey, 34010
      • Recruiting
      • Koc University Hospital
      • Contact: Özlem Özkalaycı, Md.; Phone Number: 29805 +908502508250; Email: oozkalayci@kuh.ku.edu.tr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 73 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Transversalis Fascia Plane Block and Rectus Sheath Block Group; Transversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group.	Procedure: Transversalis fascia plane block and rectus sheath block; Transversalis fascia plane block and rectus sheath block will be administered after the surgery.; Device: Intravenous fentanyl patient control device; 24-hour fentanyl consumption will be recorded.
Sham Comparator: Control Group; No regional anesthesia technique will be applied to the control group.	Device: Intravenous fentanyl patient control device; 24-hour fentanyl consumption will be recorded.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)	up to 24 hours

Collaborators and Investigators

• Sponsor: Koc University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): February 17, 2022
• Primary Completion (Anticipated): February 17, 2023
• Study Completion (Anticipated): February 17, 2023

Study Registration Dates

• First Submitted: April 5, 2022
• First Submitted That Met QC Criteria: April 5, 2022
• First Posted (Actual): April 12, 2022

Study Record Updates

• Last Update Posted (Actual): April 18, 2022
• Last Update Submitted That Met QC Criteria: April 11, 2022
• Last Verified: April 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Pain, Postoperative; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics, Intravenous; Anesthetics, General; Anesthetics; Analgesics, Opioid; Narcotics; Adjuvants, Anesthesia; Fentanyl
• Other Study ID Numbers: Koc University Hospital

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No