Regional Anesthesia MorbidityNCT04686890
Comparison of Erector Spinae Plane Block and Intravenous Analgesic in Nefrectomy
A study testing erector spinea plane block administered preoperative open nephrectomy and intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg in people with Regional Anesthesia Morbidity and Nephrectomy, run by Kocaeli University at 1 site in Turkey (Türkiye).
Trial summary
The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Regional Anesthesia Morbidity, Nephrectomy
- What is being tested?
- erector spinea plane block administered preoperative open nephrectomy and intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Dec 2020to 10 Mar 2021
- 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
- ASA I-II
- undergoing elective nephrectomy
Who cannot join
- heart disease
- pregnancy
- lung disease
- scoliosis
- bleeding disorder
- infection at the manipulation side
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Erector Spinae Plane Block for Nefrectomy
The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions
Read the detailed description
Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group. All patients will premedicated. then esp will applied to one group before surgery at the preoperative care unit by the same anesthesiologist. The other group will receive intravenous tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is responsible of all pcas' in the hospital was recorded the variables of these patients in the service
- Conditions
- Regional Anesthesia Morbidity, Nephrectomy
- Being tested
- erector spinea plane block administered preoperative open nephrectomy, intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg
- Keywords
- nefrectomy, erector spinea plane block
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
erector spinea plane block administered preoperative open nephrectomyProcedure or surgery
erector spinae plane block applied in this group before open nephrectomy
intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kgProcedure or surgery
intarvenous analgesic administered in this group for analgesia end of the open nephrectomy
| Study group | Role | What they receive |
|---|---|---|
| postoperative opiod (morphine) consumption | Active comparator | patient-controlled analgesia (15 minutes. lock time, 2 ml bolus= total 1 mg morphine intravenously, limited to maximum 4 bolus / per hour ) Receives: Procedure: erector spinea plane block administered preoperative open nephrectomy; Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg |
| peroperative continuous opioid (remifentanil) consumption | Active comparator | continuous remifentanil infusion was given during the whole procedure Receives: Procedure: erector spinea plane block administered preoperative open nephrectomy; Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg |
| postoperative numerated rating scale | Active comparator | at the 1, 3, 6, 12 and 24 th hour postoperatively - numerated rating scale score was evaluated and recoded as 0= no pain (better), 10: unbearable pain (worse) Receives: Procedure: erector spinea plane block administered preoperative open nephrectomy; Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative intravenous morphine patient controlled analgesia consumption
morphine consumptions were recorded till 24 th hour postoperatively
Measured: during postoperatively
Peroperative remifentanyl consumption
Amount of Remifentanyl consumption recorded
Measured: Peroperatively
Secondary outcomes (1)
Visual analog rating scores
pain scores were recorded during surgery
Measured: during postoperative surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2020
- Study start30 Dec 2020
- Primary completion10 Mar 2021
- Study completion10 Mar 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Regional Anesthesia MorbidityStudies 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kocaeli University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zehra Ipek ARSLAN, Kocaeli University
- Investigators
- Zehra Arslan, Principal investigator, Kocaeli University Medical Faculty
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04686890
- Sponsor's protocol ID
- KIA 2020/96
- Status last verified
- Mar 2021
- First submitted
- 7 Dec 2020
- Last updated
- 16 Mar 2021
- 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 16 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Erector Spinae Plane Block for Nefrectomy
- ClinicalTrials.gov ID
- NCT04686890
- Acronym / sponsor ID
- KIA 2020/96
- Conditions
- Regional Anesthesia Morbidity, Nephrectomy
- Keywords
- nefrectomy, erector spinea plane block
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Kocaeli UniversityUniversity, hospital or other
- Study start
- 30 Dec 2020 (actual)
- Primary completion
- 10 Mar 2021 (actual)
- Study completion
- 10 Mar 2021 (actual)
- First posted
- 29 Dec 2020 (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.
The efficacy of erector spinae plane block versus intravenous analgesics compared relate to the morphine consumptions
Detailed description
Patients undergoing elective nefrectomy were enrolled. Patients divided into two groups with a sealed envelope technique to ESP+ pca morphine group or iv analgesic + pca morphine group. All patients will premedicated. then esp will applied to one group before surgery at the preoperative care unit by the same anesthesiologist. The other group will receive intravenous tramadol 1 mg/kg + NSAID 1 ampule + parol 10 mg/ kg + ondansetron 4 mg bolus. İntravenous morphine pca with a concentration of 0.5 mg/cc were applied. And administered 1 mg boluses every 15 minutes lock time and 4 hour limit as 4 mg arranged. An anesthesia nurse who is responsible of all pcas' in the hospital was recorded the variables of these patients in the service
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| postoperative opiod (morphine) consumption | Active comparator | Procedure: erector spinea plane block administered preoperative open nephrectomy, Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kgpatient-controlled analgesia (15 minutes. lock time, 2 ml bolus= total 1 mg morphine intravenously, limited to maximum 4 bolus / per hour ) |
| peroperative continuous opioid (remifentanil) consumption | Active comparator | Procedure: erector spinea plane block administered preoperative open nephrectomy, Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kgcontinuous remifentanil infusion was given during the whole procedure |
| postoperative numerated rating scale | Active comparator | Procedure: erector spinea plane block administered preoperative open nephrectomy, Procedure: intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kgat the 1, 3, 6, 12 and 24 th hour postoperatively - numerated rating scale score was evaluated and recoded as 0= no pain (better), 10: unbearable pain (worse) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-II
- undergoing elective nephrectomy
Key exclusion criteria (6 listed)
- heart disease
- pregnancy
- lung disease
- scoliosis
- bleeding disorder
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 |
|---|---|---|
| erector spinea plane block administered preoperative open nephrectomyerector spinae plane block applied in this group before open nephrectomy | Procedure or surgery | peroperative continuous opioid (remifentanil) consumption, postoperative numerated rating scale, postoperative opiod (morphine) consumption |
| intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kgintarvenous analgesic administered in this group for analgesia end of the open nephrectomy | Procedure or surgery | peroperative continuous opioid (remifentanil) consumption, postoperative numerated rating scale, postoperative opiod (morphine) consumption |
Primary outcome
Postoperative intravenous morphine patient controlled analgesia consumption
Time frame: during postoperatively
morphine consumptions were recorded till 24 th hour postoperatively
Peroperative remifentanyl consumption
Time frame: Peroperatively
Amount of Remifentanyl consumption recorded
1 secondary outcome
Visual analog rating scores
Time frame: during postoperative surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Mar 2021.
- 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 principal investigator
Kocaeli University Medical Faculty
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing erector spinea plane block administered preoperative open nephrectomy and intravenous analgesic ( 1 mg/kg tramadol + non-steroid antiinflamatuar paracetamol )drug + 10 mg.kg in people with Regional Anesthesia Morbidity and 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 2 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: finished, as of the sponsor's last update on 16 Mar 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative intravenous morphine patient controlled analgesia consumption (time frame: during postoperatively). The study lists 2 primary outcomes in all. 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 16 Mar 2021.