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

March 5, 2024 updated by: María Teresa Fernandez, Hospital Medina del Campo

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

126

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Spain
    • VA
      • Valladolid, VA, Spain, 47008
        • María Teresa Fernandez

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
SIPB (block)
Patients undergone nephectomy and who received SIPB as analgesia
Device: ultrasound device
We performe a differnt analgesic techniques to know if some of then are better
Other Names:
  • device
Drug: Levobupivacaine
using the same AL
Other Names:
  • drug
QL block
Patients undergone nephectomy and who received QL as analgesia
Device: ultrasound device
We performe a differnt analgesic techniques to know if some of then are better
Other Names:
  • device
Drug: Levobupivacaine
using the same AL
Other Names:
  • drug
control
Patients undergone nephrectomy who didn´t receive regional anesthesia

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
pain control and quality life.Numeric rating scale (NRS)
Time Frame: "24 postoperative hours"
To assess whether SIPB is superior in pain control
"24 postoperative hours"
QoR15
Time Frame: "24hours"
Postoperative quality recovery
"24hours"

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opioids consumption
Time Frame: "48 hours"
Second outcomes was to know the consumption of intaoperative fentanyl and postoperative morphine and their side effects
"48 hours"
Side effects
Time Frame: "24hours"
We assessed the side effects of opioids
"24hours"

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
control
Time Frame: "24 hours"
Third outcome will be to know if both blocks control pain better than control group
"24 hours"

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Medina del Campo

Investigators

  • Study Chair: Maria Teresa Fernandez, Hospital Medina del Campo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2021

Primary Completion (Actual)

June 1, 2023

Study Completion (Actual)

December 1, 2023

Study Registration Dates

First Submitted

June 10, 2020

First Submitted That Met QC Criteria

June 12, 2020

First Posted (Actual)

June 16, 2020

Study Record Updates

Last Update Posted (Actual)

March 7, 2024

Last Update Submitted That Met QC Criteria

March 5, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CASVE-NM-20-434
  • 2020-000779-19 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

Yes

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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