Clinical trial NCT04431388: Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study
Official title: Analgesic Effectiveness of the Serratus-intercostal Plane Block Versus Quadratus Lumborum Block in Nephrectomy: Randomized Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Kidney Injury
Keywords: postoperative analgesia
fascial blocks
nephectomy
Lead sponsor: Hospital Medina del Campo
Sponsor class: OTHER
First posted: 2020-06-16
Enrollment: 126
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: pain control and quality life.Numeric rating scale (NRS)
timeFrame: "24 postoperative hours"
measure: QoR15
timeFrame: "24hours"
Secondary outcomes:
measure: Opioids consumption
timeFrame: "48 hours"
measure: Side effects
timeFrame: "24hours"
Other outcomes:
measure: control
timeFrame: "24 hours"
Locations:
city: Valladolid
country: Spain
facility: María Teresa Fernandez
state: VA
Study officials:
affiliation: Hospital Medina del Campo
name: Maria Teresa Fernandez
role: STUDY_CHAIR
References:
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.
citation: 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.
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.
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.