Postoperative PainNCT05324215
Transversalis Fascia Plane Block and Rectus Sheath Block in Renal Transplantation Donors
A study testing Transversalis fascia plane block and rectus sheath block in people with Postoperative Pain, run by Koc University Hospital at 1 site in Turkey (Türkiye).
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… Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Transversalis fascia plane block and rectus sheath block
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 17 Feb 2022to 17 Feb 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- American Society of Anesthesiologists (ASA) I-II
- Patients who are aged between 18-75
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Koç University Hospital
Istanbul, Zeytinburnu, 34010
Özlem Özkalaycı, Md., +908502508250 ext. 29805, oozkalayci@kuh.ku.edu.tr
About this study
Official title: 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.
- Conditions
- Postoperative Pain
- Being tested
- Transversalis fascia plane block and rectus sheath block, Intravenous fentanyl patient control device
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transversalis fascia plane block and rectus sheath blockProcedure or surgery
Transversalis fascia plane block and rectus sheath block will be administered after the surgery.
Intravenous fentanyl patient control deviceDevice
24-hour fentanyl consumption will be recorded.
| Study group | Role | What they receive |
|---|---|---|
| Transversalis Fascia Plane Block and Rectus Sheath Block Group | Active comparator | Transversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group. Receives: Procedure: Transversalis fascia plane block and rectus sheath block; Device: Intravenous fentanyl patient control device |
| Control Group | Sham comparator | No regional anesthesia technique will be applied to the control group. Receives: Device: Intravenous fentanyl patient control device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: up to 24 hours
Secondary outcomes (1)
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)
Measured: up to 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2022
- Study start17 Feb 2022
- Primary completion17 Feb 2023 (estimated)
- Study completion17 Feb 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Koc University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Özlem Özkalaycı, Koc University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05324215
- Sponsor's protocol ID
- Koc University Hospital
- Status last verified
- Apr 2022
- First submitted
- 5 Apr 2022
- Last updated
- 18 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Transversalis Fascia Plane Block and Rectus Sheath Block on Opioid Consumption in Renal Transplantation Donors
- ClinicalTrials.gov ID
- NCT05324215
- Acronym / sponsor ID
- Koc University Hospital
- Conditions
- Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Koc University HospitalUniversity, hospital or other
- Study start
- 17 Feb 2022 (actual)
- Primary completion
- 17 Feb 2023 (estimated)
- Study completion
- 17 Feb 2023 (estimated)
- First posted
- 12 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Transversalis Fascia Plane Block and Rectus Sheath Block Group | Active comparator | Procedure: Transversalis fascia plane block and rectus sheath block, Device: Intravenous fentanyl patient control deviceTransversalis Fascia Plane Block and Rectus Sheath Block will be administered to this group. |
| Control Group | Sham comparator | Device: Intravenous fentanyl patient control deviceNo regional anesthesia technique will be applied to the control group. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Donor patients scheduled for elective nephrectomy in renal transplantation surgery
- American Society of Anesthesiologists (ASA) I-II
- Patients who are aged between 18-75
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transversalis fascia plane block and rectus sheath blockTransversalis fascia plane block and rectus sheath block will be administered after the surgery. | Procedure or surgery | Transversalis Fascia Plane Block and Rectus Sheath Block Group |
| Intravenous fentanyl patient control device24-hour fentanyl consumption will be recorded. | Device | Control Group, Transversalis Fascia Plane Block and Rectus Sheath Block Group |
Primary outcome
Total opioid consumption retrieved from patient records
Time frame: 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.
1 secondary outcome
Numeric Rating Scale (NRS)
Time frame: up to 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Apr 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Transversalis fascia plane block and rectus sheath block in people with Postoperative Pain, run by Koc University Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Özlem Özkalaycı, MD (+90 850 250 8250 ext. 29805, oozkalayci@kuh.ku.edu.tr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total opioid consumption retrieved from patient records (time frame: up to 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Apr 2022.