Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR) (GenTKR)

July 17, 2019 updated by: Xavier Sala-Blanch, Hospital Clinic of Barcelona

Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty: Case-control Series

Knee Osteoarthritis affects one third of the population over 65 years old. Total knee arthroplasty (TKA) has become one of the most frequent surgical procedures in the world. During the last years it went from being a long hospital stay surgery to a fast track procedure. Currently models employ high volume local infiltration techniques (LIA). The genicular nerve block (GNB) appears as alternative in this patients.

The objective of this study is to evaluate the analgesic results of genicular nerve block after TKA in a small cohort of patients.

35 patients scheduled for TKA underwent to GNB were included. Pain measurement.

Study Overview

Status

Completed

Intervention / Treatment

Detailed Description

An observational study of a series of 35 cases will be carried out based on the casuistry of TKR surgery of the investigator's center. The performance of analgesic blockade called GNB in adult patients, ASA physical status I-III, which will undergo TKR, will be part of the multimodal analgesia strategy.

After compliance with the inclusion criteria, with the acceptance and signature of the informed consent by the participating patients, the following procedure will be followed:

  1. Patients will be routinely assessed by an anesthesiologist of the service, later they will enter the operating room, where the vital signs will be monitored and the usual anesthetic technique will be used for TKR, that is, spinal anesthesia.
  2. To perform the blocks a 90 mm needle was used, with a 30mm extension connected to a 20ml syringe with a mixture of 20ml of 0.2% ropivacaine + 200 micrograms of adrenaline. The needle will be advanced with an out-of-plane technique and 4 ml of the described solution will be placed in each of the 5 nerves to be blocked: Superomedial genicular nerve (SMGN), Superolateral genicular nerve (SLGN), Inferomedial genicular nerve (IMGN), Inferolateral genicular nerve (ILGN) and Recurrent tibial genicular nerve (RTGN) .
  3. The pain assessment will be carried out during the night after the intervention (approximately 12 hours) and the next morning (approximately 24 hours). The pain will be objectified by (VAS) (0-10) by a nurse, blind to the analgesic treatment. The use of rescue opioids will be indicated in case of VAS ≥ 3, data that will also be analyzed. In the room, the pharmacological treatment established as an institutional protocol will continue. It should be noted that these data as well as demographic data, intraoperative times, and relevant post-operative data (hematocrit, complication) were obtained from the clinical records of the electronic file of the program used in the internal network of the Barcelona Clinic Hospital
  4. Researchers will record those variables aimed at evaluating the intensity of acute postoperative pain 24 hours after TKR (Pain score ≥ 4 in any time).

These results will be included, anonymously, in an Excel database made for this purpose for further analysis. The variables will be recorded in a single intervention

Study Type

Observational

Enrollment (Actual)

35

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

      • Barcelona, Spain, 0836
        • Hospital Clínic

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

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undergoing TKR in Hospital Clinic

Description

Inclusion Criteria:

  • Subjects undergoing TKR
  • Acceptance to participate
  • ASA physical status II-III
  • Age > 18 years

Exclusion Criteria:

  • Refusal to participate in the study
  • Allergy to local anesthetics
  • History of substance abuse

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Genicular Nerve Block
GNB will be performed on this group of patients undergoing TKR. The patient will be positioned in the supine position, with the extremity to operate slightly in external rotation. The anesthesiologist will be located ipsilateral to the knee to intervene; asepsis will be performed with 70% chlorhexidine, sterile gloves will be used and the ultrasound probe will be protected with a sterile cover. The ultrasound transducer will be placed in a long axis of the knee in the corresponding area to block according to anatomical repairs. 4 ml of 0,2% ropivacaine was administered in each GN.
4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group.
Local Infiltration Analgesia
Retrospectively, the data of the patients belonging to the control group (LIA) were collected through the electronic file in the SAPP program of the internal network of the Barcelona Clinic Hospital in chronological order until completing 35 cases. To include them in the control group, the patients had to meet the same criteria as those belonging to the intervention group (GNB), therefore, the surgery should have been performed under spinal anesthesia and subsequently followed with an oral analgesia schedule meeting criteria of fast track hospitalization. The same data were obtained as in the GNBG, demographic data (age, sex, weight, height, hematocrit, hemoglobin, ASA), duration of the surgery and ischemia time, PACU VAS, AM VAS, PM VAS and finally some data of the post-operative period (hematocrit, hemoglobin, transfusion, hospital stay)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum Pain score in first day after surgery
Time Frame: 48 hours
Post operative pain scores will be recorded with a NRS(numerical rating scala) from 0 to 10 ( 0=no pain, 10= pain as bad as can be) worst score at 12 hrs, 24 hrs and 48 hrs period will be scored.
48 hours

Collaborators and Investigators

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

Investigators

  • Principal Investigator: xavier sala-blanch, MD, Hospital Clinic of Barcelona

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.

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)

May 28, 2018

Primary Completion (Actual)

September 28, 2018

Study Completion (Actual)

October 1, 2018

Study Registration Dates

First Submitted

July 15, 2019

First Submitted That Met QC Criteria

July 17, 2019

First Posted (Actual)

July 18, 2019

Study Record Updates

Last Update Posted (Actual)

July 18, 2019

Last Update Submitted That Met QC Criteria

July 17, 2019

Last Verified

July 1, 2019

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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