Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors

Sponsor
Koc University Hospital (Other)
Overall Status
Recruiting
CT.gov ID
NCT05324215
Collaborator
(none)
50
1
2
12
4.2

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: Transversalis fascia plane block and rectus sheath block
  • Device: Intravenous fentanyl patient control device
N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors
Actual Study Start Date :
Feb 17, 2022
Anticipated Primary Completion Date :
Feb 17, 2023
Anticipated Study Completion Date :
Feb 17, 2023

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

  1. Total opioid consumption retrieved from patient records [up to 24 hours]

    the amount of fentanyl required by the patient and given by the device will be recorded for the first 24 hours.

Secondary Outcome Measures

  1. Numeric Rating Scale (NRS) [up to 24 hours]

    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)

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 75 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Koç University Hospital Istanbul Zeytinburnu Turkey 34010

Sponsors and Collaborators

  • Koc University Hospital

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Özlem Özkalaycı, Principal Investigator, Koc University Hospital
ClinicalTrials.gov Identifier:
NCT05324215
Other Study ID Numbers:
  • Koc University Hospital
First Posted:
Apr 12, 2022
Last Update Posted:
Apr 18, 2022
Last Verified:
Apr 1, 2022
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of Apr 18, 2022