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 |
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Pain, Postoperative Knee Pain Chronic | Procedure: Genicular Nerve Block |
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:
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 |
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 |
Group/Cohort | Intervention/treatment |
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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.
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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.
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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)
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Spain | |
Hospital Clinic | |
Barcelona, Spain, 0836 |
Principal Investigator: | xavier sala-blanch, MD | Hospital Clinic of Barcelona |
Tracking Information | |||||
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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 |
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.
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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. |
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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:
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 |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Not Provided | ||||
Sampling Method | Probability Sample | ||||
Study Population | Patients undergoing TKR in Hospital Clinic | ||||
Condition |
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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.
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Study Groups/Cohorts |
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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Responsible Party | Xavier Sala-Blanch, Hospital Clinic of Barcelona | ||||
Study Sponsor | Hospital Clinic of Barcelona | ||||
Collaborators | Not Provided | ||||
Investigators |
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PRS Account | Hospital Clinic of Barcelona | ||||
Verification Date | July 2019 |