Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04431388
Other study ID # CASVE-NM-20-434
Secondary ID 2020-000779-19
Status Completed
Phase
First received
Last updated
Start date June 1, 2021
Est. completion date December 1, 2023

Study information

Verified date March 2024
Source Hospital Medina del Campo
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 126
Est. completion date December 1, 2023
Est. primary completion date June 1, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - signature of informed consent - age > 18 years - ASA risk scale < IV - Scheduled to nephrectomy. Exclusion Criteria: - 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.

Study Design


Related Conditions & MeSH terms


Intervention

Device:
ultrasound device
We performe a differnt analgesic techniques to know if some of then are better
Drug:
Levobupivacaine
using the same AL

Locations

Country Name City State
Spain María Teresa Fernandez Valladolid VA

Sponsors (1)

Lead Sponsor Collaborator
Hospital Medina del Campo

Country where clinical trial is conducted

Spain, 

References & Publications (4)

Corso 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. — View Citation

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. — View Citation

Fernandez 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. — View Citation

Fernandez 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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Other control Third outcome will be to know if both blocks control pain better than control group "24 hours"
Primary pain control and quality life.Numeric rating scale (NRS) To assess whether SIPB is superior in pain control "24 postoperative hours"
Primary QoR15 Postoperative quality recovery "24hours"
Secondary Opioids consumption Second outcomes was to know the consumption of intaoperative fentanyl and postoperative morphine and their side effects "48 hours"
Secondary Side effects We assessed the side effects of opioids "24hours"
See also
  Status Clinical Trial Phase
Completed NCT03550794 - Thiamine as a Renal Protective Agent in Septic Shock Phase 2
Terminated NCT04051957 - Isosorbide Mononitrate For Anti-Vascular Endothelial Growth Factor (VEGF) Induced Kidney Injury Phase 2
Completed NCT04985292 - Does Probiotic Supplementation Prevent Kidney Injury During Strenuous Physical Exercise? N/A
Completed NCT04933604 - LPN in Patients With High-complex Renal Tumors
Recruiting NCT05229328 - Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Sepsis
Completed NCT02242006 - Antimicrobial Pharmacokinetics in Critically Ill Adults During Sustained Low Efficiency Dialysis (SLED)
Terminated NCT05747053 - Personalization of Immunosuppressive Treatment for Organ Transplant Recipients
Completed NCT03407573 - Restrictive vs Liberal Transfusion Strategy on Cardiac Injury in Patients Undergoing Surgery for Fractured Neck Of Femur N/A
Withdrawn NCT00793013 - Airway Pressure Release Ventilation (APRV) Compared to ARDSnet Ventilation Phase 2
Not yet recruiting NCT06108765 - Acute Kidney Injury in Poly Trauma Patients
Recruiting NCT05155358 - Study on the Establishment of a System for Early Warning and Prognostic Evaluation of Patients With Heat Stroke
Completed NCT06008223 - Clinical Analysis of Vitamin B6 in Sepsis N/A
Completed NCT04869462 - DS Titanium Ligation Clip in Urology (Prostatectomy and Nephrectomy)
Recruiting NCT04626323 - Randomized Study Comparing Metabolic Surgery With Intensive Medical Therapy to Treat Diabetic Kidney Disease Phase 2
Active, not recruiting NCT02037321 - Meta-Analyses of the Effect of Vegetable Protein for Animal Protein on Cardiometabolic Risk N/A
Completed NCT00819871 - Nuclear Factor Kappa-B (NFKB1) Polymorphism and Organ Injury After Cardiac Surgery N/A
Recruiting NCT05812755 - SGC Stimulation, Perioperative Vascular Reactivity, and Organ Injury in Cardiac Surgery Phase 4
Recruiting NCT04902846 - Immune Checkpoint Inhibitors Nephrotoxicity
Recruiting NCT04752293 - Pediatric Hypertension and the Renin-Angiotensin SystEm (PHRASE)
Completed NCT03139123 - Prevalence of Hypotension Associated With Preload Dependence During Continuous Renal Replacement Therapy