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出境医 / 临床实验 / Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR) (GenTKR)

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

Study Description
Brief Summary:

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.


Condition or disease Intervention/treatment
Pain, Postoperative Knee Pain Chronic Procedure: Genicular Nerve Block

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 Design
Layout table for study information
Study Type : Observational
Actual Enrollment : 35 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty: Case-control Series
Actual Study Start Date : May 28, 2018
Actual Primary Completion Date : September 28, 2018
Actual Study Completion Date : October 1, 2018
Arms 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.
Procedure: Genicular Nerve Block
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)
Outcome Measures
Primary Outcome Measures :
  1. 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.


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Patients undergoing TKR in Hospital Clinic
Criteria

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
Contacts and Locations

Locations
Layout table for location information
Spain
Hospital Clinic
Barcelona, Spain, 0836
Sponsors and Collaborators
Hospital Clinic of Barcelona
Investigators
Layout table for investigator information
Principal Investigator: xavier sala-blanch, MD Hospital Clinic of Barcelona
Tracking Information
First Submitted Date July 15, 2019
First Posted Date July 18, 2019
Last Update Posted Date July 18, 2019
Actual Study Start Date May 28, 2018
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: July 17, 2019)
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.
Original Primary Outcome Measures Same as current
Change History No Changes Posted
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR)
Official Title Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty: Case-control Series
Brief Summary

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.

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
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Patients undergoing TKR in Hospital Clinic
Condition
  • Pain, Postoperative
  • Knee Pain Chronic
Intervention Procedure: Genicular Nerve Block
4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group.
Study Groups/Cohorts
  • 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.
    Intervention: Procedure: Genicular Nerve Block
  • 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)
Publications * Pietrantoni P, Cuñat T, Nuevo-Gayoso M, Martín N, Tió M, Basora M, Sastre S, Sala-Blanch X. Ultrasound-guided genicular nerves block: an analgesic alternative to local infiltration analgesia for total knee arthroplasty: A noninferiority, matched cohort study. Eur J Anaesthesiol. 2021 May 25. doi: 10.1097/EJA.0000000000001546. [Epub ahead of print]

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: July 17, 2019)
35
Original Actual Enrollment Same as current
Actual Study Completion Date October 1, 2018
Actual Primary Completion Date September 28, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

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
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT04024319
Other Study ID Numbers HCB/2018/0463
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party Xavier Sala-Blanch, Hospital Clinic of Barcelona
Study Sponsor Hospital Clinic of Barcelona
Collaborators Not Provided
Investigators
Principal Investigator: xavier sala-blanch, MD Hospital Clinic of Barcelona
PRS Account Hospital Clinic of Barcelona
Verification Date July 2019