Laparoscopic NephrectomyNCT05913167
Comparison of Erector Spina Plan Block and Trnsversus Abdominis Plan Block in Laparoscopic Nephrectomy: Prospective Randomized Clinical Trial
A study testing laparoscopic nephrectomy in people with Laparoscopic Nephrectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Laparoscopic Nephrectomy
- What is being tested?
- laparoscopic nephrectomy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2023to 15 Jun 2026
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-65 age
- patients undergoing laparoscopic nephrectomy
- ASA 1-3
Who cannot join
- <18- >65 < age
- patients undergoing open nephrectomy
- ASA 4-5
Trial locations and contacts
1 site in 1 country.
Zehra Arslan contact
Turkey (Türkiye)1 site, 1 recruiting
- Recruiting
Kocaeli University
Kocaeli, 41900
Zehra Ipek ARSLAN, Associate Professor, 00905325011339, zehraipek48@gmail.com
Zehra I ARSLAN, Associate Professor
About this study
Official title: Comparison of Erector Spina and Transversus Abdominus Plan Blocks
Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.
Read the detailed description
Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.
- Conditions
- Laparoscopic Nephrectomy
- Being tested
- laparoscopic nephrectomy
- Keywords
- laparoscopy, nephrectomy, erector spina plan block, transversus abdominis plan block, morphine consumption, analgesia
- Medical subject headings
- Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
laparoscopic nephrectomyProcedure or surgery
laparoscopic nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| Erector spina plan block | Active comparator | Erector spina plan block will be administered to the patients in this group. Receives: Procedure: laparoscopic nephrectomy |
| Transversus abdominis plan block | Active comparator | Transversus abdominis plan block will be administered to the patients in this group. Receives: Procedure: laparoscopic nephrectomy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative morphine consumption
morphine patient controlled analgesia was applied to the patients
Measured: 24 hour postoperatively
Secondary outcomes (2)
Peroperative remifentanil consumptions
continious remifentanil infusion was applied
Measured: peroperatively
postoperative analgesia numeric rating scales
patients will give numbers to their pain first hour, 6th hour and 24 th hour after surgery
Measured: postoperative 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2023
- Study start15 Aug 2023
- Primary completion15 Jun 2026 (estimated)
- Study completion15 Jun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Laparoscopic NephrectomyStudies 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
- Model description
- erector spina and transversus abdominis plane blocks
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 50 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
- NCT05913167
- Sponsor's protocol ID
- LAPNEF2023
- Status last verified
- Dec 2023
- First submitted
- 12 Jun 2023
- Last updated
- 15 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 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Erector Spina and Transversus Abdominus Plan Blocks
- ClinicalTrials.gov ID
- NCT05913167
- Acronym / sponsor ID
- LAPNEF2023
- Conditions
- Laparoscopic Nephrectomy
- Keywords
- laparoscopy, nephrectomy, erector spina plan block, transversus abdominis plan block, morphine consumption, analgesia
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 15 Aug 2023 (actual)
- Primary completion
- 15 Jun 2026 (estimated)
- Study completion
- 15 Jun 2026 (estimated)
- First posted
- 22 Jun 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.
Nephrectomy pain was higher. erector spina plan block and transversus abdominis plan block had shown to be effective in abdominal surgeries. This study aimed to compare these two bloc analgesic efficacy in laparoscopic nephrectomy patients. The primary aim is postoperative morphine consumption.
Detailed description
Patients ASA 18-65 who will undergo laparoscopic nephrectomy are included in this prospective randomized clinical trial. Patients will be divided into two groups; erector spina and transversus abdominis plane block. Anesthesia will. induced with propofol, fentanyl, and rocuronium will be administered for muscle relaxation. Bispectral index monitoring will be used for monitorisation of the depth of anesthesia. Remifentanil was used during the whole procedure. the amount of consumption will be recorded. Patient-controlled device will be used with morphine. The postoperative morphine consumption will also be recorded.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- erector spina and transversus abdominis plane blocks
| Arm | Type | Receives |
|---|---|---|
| Erector spina plan block | Active comparator | Procedure: laparoscopic nephrectomyErector spina plan block will be administered to the patients in this group. |
| Transversus abdominis plan block | Active comparator | Procedure: laparoscopic nephrectomyTransversus abdominis plan block will be administered to the patients in this group. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 18-65 age
- patients undergoing laparoscopic nephrectomy
- ASA 1-3
Key exclusion criteria (3 listed)
- <18- >65 < age
- patients undergoing open nephrectomy
- ASA 4-5
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 |
|---|---|---|
| laparoscopic nephrectomylaparoscopic nephrectomy | Procedure or surgery | Erector spina plan block, Transversus abdominis plan block |
Primary outcome
Postoperative morphine consumption
Time frame: 24 hour postoperatively
morphine patient controlled analgesia was applied to the patients
2 secondary outcomes
Peroperative remifentanil consumptions
Time frame: peroperatively
postoperative analgesia numeric rating scales
Time frame: postoperative 24 hours
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 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. This study is not recruiting at the moment.
Zehra Arslan contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing laparoscopic nephrectomy in people with Laparoscopic Nephrectomy, run by Kocaeli University 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 3 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 15 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 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. 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 Zehra Arslan (0090303 ext. 8168, zehraipekarslan@hotmail.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 15 Oct 2024.