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

Postoperative Pain Clinical Trial

Official title:

Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05324215
• Other study ID #: Koc University Hospital
• Status: Recruiting
• Phase: N/A
• Start date: February 17, 2022
• Est. completion date: February 17, 2023

Study information

• Verified date: April 2022
• Source: Koc University Hospital
• Contact: Özlem Özkalayci, MD
• Phone: +90 850 250 8250
• Email: oozkalayci[@]kuh.ku.edu.tr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: February 17, 2023
• Est. primary completion date: February 17, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

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.

Locations

Country	Name	City	State
Turkey	Koç University Hospital	Istanbul	Zeytinburnu

Sponsors (1)

Lead Sponsor	Collaborator
Koc University Hospital

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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