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

NCT ID: NCT05324215

Last Updated: 2022-04-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-02-17

Study Completion Date

2023-02-17

Brief Summary

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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.

Detailed Description

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Conditions

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Postoperative Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Transversalis Fascia Plane Block and Rectus Sheath Block Group

Transversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group.

Group Type ACTIVE_COMPARATOR

Transversalis fascia plane block and rectus sheath block

Intervention Type PROCEDURE

Transversalis fascia plane block and rectus sheath block will be administered after the surgery.

Intravenous fentanyl patient control device

Intervention Type DEVICE

24-hour fentanyl consumption will be recorded.

Control Group

No regional anesthesia technique will be applied to the control group.

Group Type SHAM_COMPARATOR

Intravenous fentanyl patient control device

Intervention Type DEVICE

24-hour fentanyl consumption will be recorded.

Interventions

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Transversalis fascia plane block and rectus sheath block

Transversalis fascia plane block and rectus sheath block will be administered after the surgery.

Intervention Type PROCEDURE

Intravenous fentanyl patient control device

24-hour fentanyl consumption will be recorded.

Intervention Type DEVICE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Koc University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Özlem Özkalaycı

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Koç University Hospital

Istanbul, Zeytinburnu, Turkey (Türkiye)

Site Status RECRUITING

Countries

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Turkey (Türkiye)

Central Contacts

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Özlem Özkalaycı, MD

Role: CONTACT

+90 850 250 8250 ext. 29805

Facility Contacts

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Özlem Özkalaycı, Md.

Role: primary

+908502508250 ext. 29805

Other Identifiers

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Koc University Hospital

Identifier Type: -

Identifier Source: org_study_id

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