Kidney InjuryNCT04431388
Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study
An observational study of Kidney Injury, run by Hospital Medina del Campo at 1 site in Spain.
Trial summary
Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain, but there are still some patients who describe a severe pain after this surgery. Regional techniques allow a better recovery quality and adequate- managed pain control. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Injury
- What is being tested?
- ultrasound device and Levobupivacaine
- Type of treatment
- Medical device
- How many people
- 126 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jun 2021to 1 Dec 2023
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A sample size of 80 patients (40 in each group) has been calculated assuming that we intend to confirm a 15% improvement in pain control and postoperative recovery in the serratus-intercostal plane block group.
Who may be able to join
- signature of informed consent
- age > 18 years
- ASA risk scale < IV
- Scheduled to nephrectomy.
Who cannot join
- Patients with cognitive impairment or inability to sign informed consent,
- Refused to participate
- Hypersensitivity to the drugs used
- contraindication of regional technique (coagulopathy, infection)
- history of chronic pain.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Analgesic Effectiveness of the Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study
Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain, but there are still some patients who describe a severe pain after this surgery. Regional techniques allow a better recovery quality and adequate- managed pain control.
Read the detailed description
Adequate control of pain in patients with nephrectomy is a challenge for the anesthesiologist who must achieve an early recovery with minimal adverse effects. Within a multimodal strategy, the work hypothesis is based on comparing the analgesic efficacy of two regional techniques in patients undergoing nephrectomy, in terms of quality of postoperative recovery, pain control, absence of adverse effects and ease of performance.
- Conditions
- Kidney Injury
- Being tested
- ultrasound device, Levobupivacaine
- Keywords
- postoperative analgesia, fascial blocks, nephectomy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ultrasound deviceDevice
Also called device
We performe a differnt analgesic techniques to know if some of then are better
LevobupivacaineDrug
Also called drug
using the same AL
| Study group | Role | What they receive |
|---|---|---|
| SIPB (block) | Patients undergone nephectomy and who received SIPB as analgesia Receives: Device: ultrasound device; Drug: Levobupivacaine | |
| QL block | Patients undergone nephectomy and who received QL as analgesia Receives: Device: ultrasound device; Drug: Levobupivacaine | |
| control | Patients undergone nephrectomy who didn´t receive regional anesthesia |
What is being measured
The primary outcome is the main question the study is designed to answer.
pain control and quality life.Numeric rating scale (NRS)
To assess whether SIPB is superior in pain control
Measured: "24 postoperative hours"
QoR15
Postoperative quality recovery
Measured: "24hours"
Secondary outcomes (2)
Opioids consumption
Second outcomes was to know the consumption of intaoperative fentanyl and postoperative morphine and their side effects
Measured: "48 hours"
Side effects
We assessed the side effects of opioids
Measured: "24hours"
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jun 2020
- Study start1 Jun 2021
- Primary completion1 Jun 2023
- Study completion1 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Kidney InjuryStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Medina del Campo
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, María Teresa Fernandez, Hospital Medina del Campo
- Investigators
- Maria Teresa Fernandez, Study chair, Hospital Medina del Campo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04431388
- Sponsor's protocol ID
- CASVE-NM-20-434
- Other IDs
- 2020-000779-19
- Status last verified
- Mar 2024
- First submitted
- 10 Jun 2020
- Last updated
- 7 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Publications
Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Ultrasound-guided transmuscular quadratus lumborum block for perioperative analgesia in open nephrectomy. Minerva Anestesiol. 2017 Dec;83(12):1334-1335. doi: 10.23736/S0375-9393.17.12167-X. Epub 2017 Jul 5. No abstract available.
PubMed 28679202Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Transmuscular quadratus lumborum block versus serratus-intercostal interfascial plane block: the game has just begun. Minerva Anestesiol. 2018 Jul;84(7):873-874. doi: 10.23736/S0375-9393.18.12849-5. Epub 2018 Mar 27. No abstract available.
PubMed 29589427Fernandez Martin MT, Lopez Alvarez S, Fajardo Perez M, Perez Herrero M. Serratus-intercostal interfascial plane block: alternative analgesia for open nephrectomy? Minerva Anestesiol. 2018 Jul;84(7):872-873. doi: 10.23736/S0375-9393.18.12808-2. Epub 2018 Feb 22. No abstract available.
PubMed 29479932Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
PubMed 29789137
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Effectiveness of the Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study
- ClinicalTrials.gov ID
- NCT04431388
- Acronym / sponsor ID
- CASVE-NM-20-434
- Conditions
- Kidney Injury
- Keywords
- postoperative analgesia, fascial blocks, nephectomy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- Hospital Medina del CampoUniversity, hospital or other
- Study start
- 1 Jun 2021 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 1 Dec 2023 (actual)
- First posted
- 16 Jun 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.
Performing the nephrectomy by laparoscopy has decrease the incidence of postoperative pain, but there are still some patients who describe a severe pain after this surgery. Regional techniques allow a better recovery quality and adequate- managed pain control.
Detailed description
Adequate control of pain in patients with nephrectomy is a challenge for the anesthesiologist who must achieve an early recovery with minimal adverse effects. Within a multimodal strategy, the work hypothesis is based on comparing the analgesic efficacy of two regional techniques in patients undergoing nephrectomy, in terms of quality of postoperative recovery, pain control, absence of adverse effects and ease of performance.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| SIPB (block) | – | Device: ultrasound device, Drug: LevobupivacainePatients undergone nephectomy and who received SIPB as analgesia |
| QL block | – | Device: ultrasound device, Drug: LevobupivacainePatients undergone nephectomy and who received QL as analgesia |
| control | – | –Patients undergone nephrectomy who didn´t receive regional anesthesia |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A sample size of 80 patients (40 in each group) has been calculated assuming that we intend to confirm a 15% improvement in pain control and postoperative recovery in the serratus-intercostal plane block group.
Key inclusion criteria (4 listed)
- signature of informed consent
- age > 18 years
- ASA risk scale < IV
- Scheduled to nephrectomy.
Key exclusion criteria (5 listed)
- Patients with cognitive impairment or inability to sign informed consent,
- Refused to participate
- Hypersensitivity to the drugs used
- contraindication of regional technique (coagulopathy, infection)
- history of chronic pain.
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 |
|---|---|---|
| ultrasound deviceAlso: deviceWe performe a differnt analgesic techniques to know if some of then are better | Device | QL block, SIPB (block) |
| LevobupivacaineAlso: drugusing the same AL | Drug | QL block, SIPB (block) |
Primary outcome
pain control and quality life.Numeric rating scale (NRS)
Time frame: "24 postoperative hours"
To assess whether SIPB is superior in pain control
QoR15
Time frame: "24hours"
Postoperative quality recovery
2 secondary outcomes
Opioids consumption
Time frame: "48 hours"
Side effects
Time frame: "24hours"
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 7 Mar 2024.
- Background: PubMed 28679202Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Ultrasound-guided transmuscular quadratus lumborum block for perioperative analgesia in open nephrectomy. Minerva Anestesiol. 2017 Dec;83(12):1334-1335. doi: 10.23736/S0375-9393.17.12167-X. Epub 2017 Jul 5. No abstract available.
- Background: PubMed 29589427Corso RM, Piraccini E, Sorbello M, Bellantonio D, Tedesco M. Transmuscular quadratus lumborum block versus serratus-intercostal interfascial plane block: the game has just begun. Minerva Anestesiol. 2018 Jul;84(7):873-874. doi: 10.23736/S0375-9393.18.12849-5. Epub 2018 Mar 27. No abstract available.
- Background: PubMed 29479932Fernandez Martin MT, Lopez Alvarez S, Fajardo Perez M, Perez Herrero M. Serratus-intercostal interfascial plane block: alternative analgesia for open nephrectomy? Minerva Anestesiol. 2018 Jul;84(7):872-873. doi: 10.23736/S0375-9393.18.12808-2. Epub 2018 Feb 22. No abstract available.
- Background: PubMed 29789137Fernandez Martin MT, Lopez Alvarez S, Perez Herrero MA. Serratus-intercostal interfascial block as an opioid-saving strategy in supra-umbilical open surgery. Rev Esp Anestesiol Reanim (Engl Ed). 2018 Oct;65(8):456-460. doi: 10.1016/j.redar.2018.03.007. Epub 2018 May 20. English, Spanish.
- Individual participant dataSharing planned: Undecided
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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.
Maria Teresa Fernandez study chair
Hospital Medina del Campo
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Injury, run by Hospital Medina del Campo at 1 site in Spain.
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 4 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: finished, as of the sponsor's last update on 7 Mar 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 Spain. 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?
pain control and quality life.Numeric rating scale (NRS) (time frame: "24 postoperative hours"). 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?
On the ClinicalTrials.gov record for NCT04431388, which also lists 4 linked publications.
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 7 Mar 2024.