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NCT04431388 Clinical Trial

Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study

Kidney Injury Clinical Trial

Official title:
Analgesic Effectiveness of the Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study

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"
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