Renal Cell CarcinomaNCT05810571
Comparison of Postoperative Analgesic Efficacy of the Erector Spina Plane Block and Quadratus Lumborum Block in Open Nephrectomy: a Prospective Randomized Clinical Study
A study testing preoperative remifentanil consumption in people with Renal Cell Carcinoma, run by Kocaeli University at 2 sites in Turkey (Türkiye).
Trial summary
patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Renal Cell Carcinoma
- What is being tested?
- preoperative remifentanil consumption
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 2 sitesTurkey (Türkiye)
- Study dates
- 24 Oct 2024to 3 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA 1-3
- open nephrectomy elective patients
- BMI<35
Who cannot join
- ASA 4-5-6
- Laparoscopic nephrectomy
- infection at the block side
- coagulation disorder
- BMI>35
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)2 sites, 1 recruiting
- Recruiting
Kocaeli University Medical Faculty
İzmit, 41100
Zehra İpek Arslan, Professor, 00905325011339, zehraipek48@gmail.com
- Active, not recruiting
Kocaeli University Medical Faculty
Kocaeli
About this study
Official title: Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy
patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.
Read the detailed description
patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continious remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.
- Conditions
- Renal Cell Carcinoma
- Being tested
- preoperative remifentanil consumption, postopeartive controlled anlagesia with morphine
- Keywords
- erector spina plane block, quadratus lumborum block, patient controlled analgesia, nephrectomy, analgesia
- Medical subject headings
- Carcinoma, Renal Cell, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
preoperative remifentanil consumptionProcedure or surgery
continuous remifentanil infusion will applied for peroperative analgesia
postopeartive controlled anlagesia with morphineProcedure or surgery
postoperative morphine patient controlled analgesia will be applied for postoperative analgesia
| Study group | Role | What they receive |
|---|---|---|
| patient controlled analgesia | Placebo comparator | this group of patients received no block, received only postoperative patient-controlled analgesia with morphine Receives: Procedure: preoperative remifentanil consumption; Procedure: postopeartive controlled anlagesia with morphine |
| erector spina plane block | Active comparator | this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine Receives: Procedure: preoperative remifentanil consumption; Procedure: postopeartive controlled anlagesia with morphine |
| quadratus lumborum block | Active comparator | this group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine Receives: Procedure: preoperative remifentanil consumption; Procedure: postopeartive controlled anlagesia with morphine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative morphine consumption
amount of postoperative morphine use of the patient's
Measured: 24 hour postoperatively
Secondary outcomes (2)
peroperative remifentanil consumptions
amount of remifentanil use of the patient's
Measured: 4 hour preoperatively
numeric rating scale
numeric rating scores of the patient's postoepartively
Measured: 24 hour postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2023
- Study start24 Oct 2024
- Primary completion3 Jan 2027 (estimated)
- Study completion3 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renal Cell CarcinomaStudies 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
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05810571
- Sponsor's protocol ID
- KAEK / 12bl.01
- Status last verified
- Sep 2024
- First submitted
- 31 Mar 2023
- Last updated
- 26 Oct 2024
- 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 26 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina and Quadratus Lumborum in Open Nephrectomy
- ClinicalTrials.gov ID
- NCT05810571
- Acronym / sponsor ID
- KAEK / 12bl.01
- Conditions
- Renal Cell Carcinoma
- Keywords
- erector spina plane block, quadratus lumborum block, patient controlled analgesia, nephrectomy, analgesia
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 24 Oct 2024 (actual)
- Primary completion
- 3 Jan 2027 (estimated)
- Study completion
- 3 Jan 2027 (estimated)
- First posted
- 12 Apr 2023 (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.
patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block, and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continuous remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.
Detailed description
patients who will undergo elective open nephrectomy will be divided into three groups; the control (PCA), the erector spina plane block and the quadratus lumborum block. After standard anesthesia induction and monitorization then Bispectral index monitoring will be applied to all patients. Anesthesia will be maintained using sevoflurane in a mixture of oxygen and air. Continious remifentanil infusion will be used for analgesia. Then patient's numeric rating scales and morphine pca consumptions will be recorded for one day.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| patient controlled analgesia | Placebo comparator | Procedure: preoperative remifentanil consumption, Procedure: postopeartive controlled anlagesia with morphinethis group of patients received no block, received only postoperative patient-controlled analgesia with morphine |
| erector spina plane block | Active comparator | Procedure: preoperative remifentanil consumption, Procedure: postopeartive controlled anlagesia with morphinethis group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine |
| quadratus lumborum block | Active comparator | Procedure: preoperative remifentanil consumption, Procedure: postopeartive controlled anlagesia with morphinethis group of patients received erector spina plane block preoperatively, received only postoperative patient-controlled analgesia with morphine |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- ASA 1-3
- open nephrectomy elective patients
- BMI<35
Key exclusion criteria (5 listed)
- ASA 4-5-6
- Laparoscopic nephrectomy
- infection at the block side
- coagulation disorder
- BMI>35
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 |
|---|---|---|
| preoperative remifentanil consumptioncontinuous remifentanil infusion will applied for peroperative analgesia | Procedure or surgery | erector spina plane block, patient controlled analgesia, quadratus lumborum block |
| postopeartive controlled anlagesia with morphinepostoperative morphine patient controlled analgesia will be applied for postoperative analgesia | Procedure or surgery | erector spina plane block, patient controlled analgesia, quadratus lumborum block |
Primary outcome
postoperative morphine consumption
Time frame: 24 hour postoperatively
amount of postoperative morphine use of the patient's
2 secondary outcomes
peroperative remifentanil consumptions
Time frame: 4 hour preoperatively
numeric rating scale
Time frame: 24 hour postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2024.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing preoperative remifentanil consumption in people with Renal Cell Carcinoma, run by Kocaeli University at 2 sites 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 5 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: looking for participants now, as of the sponsor's last update on 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact zehra ipek Arslan AYDIN, Professor (00905325011339, zehraipek48@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
postoperative morphine consumption (time frame: 24 hour postoperatively). 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 26 Oct 2024.