Pain, PostoperativeGenTKRNCT04024319
Ultrasound-guided Genicular Nerve Block for Total Knee Arthroplasty (GenTKR)
An observational study of Pain, Postoperative and Knee Pain Chronic, run by Hospital Clinic of Barcelona at 1 site in Spain.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pain, Postoperative, Knee Pain Chronic
- What is being tested?
- Genicular Nerve Block
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- How many people
- 35 participants
- Where
- 1 siteSpain
- Study dates
- 28 May 2018to 1 Oct 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients undergoing TKR in Hospital Clinic
Who may be able to join
- Subjects undergoing TKR
- Acceptance to participate
- ASA physical status II-III
- Age > 18 years
Who cannot join
- Refusal to participate in the study
- Allergy to local anesthetics
- History of substance abuse
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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:
- 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.
- 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) .
- 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
- 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
- Conditions
- Pain, Postoperative, Knee Pain Chronic
- Being tested
- Genicular Nerve Block
- Keywords
- Total Knee Replacement, Genicular nerves block, Postoperative pain
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genicular Nerve BlockProcedure or surgery
4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum Pain score in first day after surgery
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.
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2019
- Study start28 May 2018
- Primary completion28 Sep 2018
- Study completion1 Oct 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pain, PostoperativeStudies of the same condition, open and under way.
- More trials run by Hospital Clinic of BarcelonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital Clinic of Barcelona
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xavier Sala-Blanch, Hospital Clinic of Barcelona
- Investigators
- xavier sala-blanch, MD, Principal investigator, Hospital Clinic of Barcelona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04024319
- Sponsor's protocol ID
- HCB/2018/0463
- Acronym
- GenTKR
- Status last verified
- Jul 2019
- First submitted
- 15 Jul 2019
- Last updated
- 18 Jul 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Pietrantoni P, Cunat T, Nuevo-Gayoso M, Martin N, Tio 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 Aug 1;38(Suppl 2):S130-S137. doi: 10.1097/EJA.0000000000001546.
PubMed 34038916
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ultrasound-guided Genicular Nerve Block an Analgesic Alternative to LIA for Total Knee Arthroplasty: Case-control Series
- ClinicalTrials.gov ID
- NCT04024319
- Acronym / sponsor ID
- GenTKR / HCB/2018/0463
- Conditions
- Pain, Postoperative, Knee Pain Chronic
- Keywords
- Total Knee Replacement, Genicular nerves block, Postoperative pain
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Hospital Clinic of BarcelonaUniversity, hospital or other
- Study start
- 28 May 2018 (actual)
- Primary completion
- 28 Sep 2018 (actual)
- Study completion
- 1 Oct 2018 (actual)
- First posted
- 18 Jul 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
- 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) .
- 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
- 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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular Nerve Block | – | Procedure: Genicular Nerve BlockGNB 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. |
| 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) |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undergoing TKR in Hospital Clinic
Key inclusion criteria (4 listed)
- Subjects undergoing TKR
- Acceptance to participate
- ASA physical status II-III
- Age > 18 years
Key exclusion criteria (3 listed)
- Refusal to participate in the study
- Allergy to local anesthetics
- History of substance abuse
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Genicular Nerve Block4 ml of local anesthetic were administered in 5 genicular nerves. A total volume of 20 ml were administered in GNB group. | Procedure or surgery | Genicular Nerve Block |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2019.
- Derived from this study: PubMed 34038916Pietrantoni P, Cunat T, Nuevo-Gayoso M, Martin N, Tio 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 Aug 1;38(Suppl 2):S130-S137. doi: 10.1097/EJA.0000000000001546.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
xavier sala-blanch, MD principal investigator
Hospital Clinic of Barcelona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pain, Postoperative and Knee Pain Chronic, run by Hospital Clinic of Barcelona at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Maximum Pain score in first day after surgery (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04024319, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2019.