Anesthesia, ConductionPhase 4NCT03623230
Concentration Effect of Local Anesthetics on Femoral Nerve Block Efficiency
A Phase 4 study testing Ultrasound Guided Femoral Nerve Block, Dressing and Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Conduction and Arthroplasty, Replacement, Knee, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
Trial summary
US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anesthesia, Conduction, Arthroplasty, Replacement, Knee, Pain, Postoperative
- What is being tested?
- Ultrasound Guided Femoral Nerve Block, Dressing and Bupivacaine 0.25% Injectable Solution
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 63 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Aug 2018to 15 Feb 2019
- Phase
- Phase 4
- 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
Who may be able to join
- Patients who are scheduled for primary unilateral total knee arthroplasty under spinal anesthesia
- Patients who has informed consent for study
Who cannot join
- Patient's refusal to participate
- Patients under 18 years of age
- Patients who are undergoing surgery with an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, laryngeal mask application, etc.)
- Patients with known local anesthetic allergy
- Patients with Body mass index > 35
- Patients diagnosed sepsis and bacteriemia,
Show all 13Show fewer
- Skin infection at the injection site,
- History of coagulopathy or anticoagulant therapy
- Patients with uncontrolled diabetes ,
- Uncoordinated patients,
- Psychological and emotional lability,
- Surgical intervention longer than 3 hours.
- Patients with pre-operative limitation of movement
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Izmir Bozyaka Training and Research Hospital
Karabağlar, İzmir, 35170
About this study
Official title: Concentration-Volume Relationship of Bupivacaine in Femoral Nerve Block Efficiency for Postoperative Analgesia in Primary Total Knee Arthroplasty: A Randomized Controlled Double Blind Clinical Trial
US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.
Read the detailed description
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment.
- Control Group(GCont) patients will only be applied sterile dressing for the purpose of blinding the patient and the follow-up physician.
- 0.125% Bupivacaine Group(G125) patients will be administered femoral block with 20 ml 0.125% Bupivacaine by an experienced anesthesiologist.
- 0.25% Bupivacaine Group(G25) patients 10ml will be administered femoral block with 0.25% Bupivacaine by an experienced anesthesiologist.
The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.
- Conditions
- Anesthesia, Conduction, Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia
- Being tested
- Ultrasound Guided Femoral Nerve Block, Dressing, Bupivacaine 0.25% Injectable Solution, Bupivacaine 0.125% Injectable Solution
- Keywords
- Femoral nerve block, peripheral nerve block, Concentration, volume, bupivacaine, post operative analgesia, total knee arthroplasty
- Medical subject headings
- Pain, Postoperative, Agnosia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ultrasound Guided Femoral Nerve BlockProcedure or surgery
Also called Regional Anesthesia
Femoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator
DressingOther
Only dressing will be applied to related area to protect blindness between groups
Bupivacaine 0.25% Injectable SolutionDrug
Also called Marcaine
Perineural Injection
Bupivacaine 0.125% Injectable SolutionDrug
Also called Marcain
Perineural Injection
| Study group | Role | What they receive |
|---|---|---|
| GCont | Sham comparator | Only dressing will be applied to patients without actually nerve block performed Receives: Other: Dressing |
| G125 Block | Active comparator | Ultrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block.
5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution. Receives: Procedure: Ultrasound Guided Femoral Nerve Block; Drug: Bupivacaine 0.125% Injectable Solution |
| G25 Block | Active comparator | Ultrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block.
5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution. Receives: Procedure: Ultrasound Guided Femoral Nerve Block; Drug: Bupivacaine 0.25% Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 30th minute postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 1st hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 2nd hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 6th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 12th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 24th hour postoperatively
Post-operative pain assessed by Numeric Rating Scale (NRS)
Pain scores will be recorded as reported by the patient according to NRS
Measured: 48th hour postoperatively
Secondary outcomes (2)
Ambulation Time
First time a patients can walk around independently
Measured: 72 hours post-operatively
Opioid Consumption
Opioids(Tramadol) will be administered to patients in case demanded.
Measured: 48 hour post-operatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2018
- Study start10 Aug 2018
- Primary completion12 Dec 2018
- Study completion15 Feb 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Anesthesia, ConductionStudies of the same condition, open and under way.
- 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three groups involved. One control group and two nerve block groups with different drug concentration
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 63 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bozyaka Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Zeki T TEKGUL, Associate Professor, Study director, Izmir Bozyaka Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03623230
- Sponsor's protocol ID
- DizFemoralKonsant
- Status last verified
- Jul 2019
- First submitted
- 30 Jun 2018
- Last updated
- 10 Jul 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
PubMed 28273133Tulgar S, Selvi O, Senturk O, Serifsoy TE, Sanel S, Meydaneri S. Evaluation of analgesic regimens in total knee arthroplasty, retrospective study. North Clin Istanb. 2017 Aug 25;4(2):124-130. doi: 10.14744/nci.2017.88598. eCollection 2017.
PubMed 28971169Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
PubMed 29026354
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Concentration-Volume Relationship of Bupivacaine in Femoral Nerve Block Efficiency for Postoperative Analgesia in Primary Total Knee Arthroplasty: A Randomized Controlled Double Blind Clinical Trial
- ClinicalTrials.gov ID
- NCT03623230
- Acronym / sponsor ID
- DizFemoralKonsant
- Conditions
- Anesthesia, Conduction, Arthroplasty, Replacement, Knee, Pain, Postoperative, Anesthesia and Analgesia
- Keywords
- Femoral nerve block, peripheral nerve block, Concentration, volume, bupivacaine, post operative analgesia, total knee arthroplasty
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 63 participants (actual)
- Lead sponsor
- Bozyaka Training and Research HospitalUniversity, hospital or other
- Study start
- 10 Aug 2018 (actual)
- Primary completion
- 12 Dec 2018 (actual)
- Study completion
- 15 Feb 2019 (actual)
- First posted
- 9 Aug 2018 (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.
US-guided femoral nerve block is used effectively in post-operative pain management in the surgical treatment of the lower extremity. However, the volume and concentration of the local anesthetic drug to be administered remains controversial. In this prospective, randomized, double-blinded study, patients who underwent unilateral primary total knee arthroplasty and successfully performed spinal anesthesia with standard method and dosage, will be selected for US-guided femoral nerve block after the operation. Patients will be divided into three groups with simple randomization. The First group will be determined as the control group (GCont) and only dressing will be applied to the patients. For second group(G125), 0,125% 20 ml local anesthetic and for the third group (G25), 0,25% 10 ml local anesthetic will be administered to the femoral nerve without changing the drug dose (25 mg bupivacaine). Whether there is a difference between post-op analgesia durations, motor block formation, mobilization time and 90° flexion time between the groups will be investigated.
Detailed description
All patients scheduled for total knee arthroplasty will be evaluated before the operation. Eligible patients will be informed about the study and "Numeric Rating Scale" for pain evaluation. Then, patients will be asked for informed consent. After approval from the local research ethics committee, first patient will be recruited for study and patient's group will be determined by dice roll(1,4: GCont - 2,5: G125 - 3,6: G25). Patients who are scheduled for primary total knee arthroplasty under spinal anesthesia with a planned sensory block level between T4 and T7 dermatomes, will be recruited and assigned to a group. After successfully completed surgery, patients will be administered femoral nerve block or only dressing according to the relevant group. Before femoral nerve block is performed, patients will be re-informed about Numeric Rating Scale(NRS) and will be asked to rate their pain at the moment.
- Control Group(GCont) patients will only be applied sterile dressing for the purpose of blinding the patient and the follow-up physician.
- 0.125% Bupivacaine Group(G125) patients will be administered femoral block with 20 ml 0.125% Bupivacaine by an experienced anesthesiologist.
- 0.25% Bupivacaine Group(G25) patients 10ml will be administered femoral block with 0.25% Bupivacaine by an experienced anesthesiologist.
The procedures will be performed in the operating room under both US and nerve stimulator guidance. Patients will be followed-up in post-anesthesia care unit and in the ward for 48 hours. Scheduled and on-demand(Tramadol) medication for analgesia will be ordered and nurses will be informed about the study. Patients' pain scores and ambulation times will be followed-up by another anesthesiologist and on-demand medication will be recorded and monitored from hospital's computer based hospital management program online. Patients will be followed-up for six months after the surgery in order to explore potential long term benefits and complications.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 3
- Model description
- Three groups involved. One control group and two nerve block groups with different drug concentration
| Arm | Type | Receives |
|---|---|---|
| GCont | Sham comparator | Other: DressingOnly dressing will be applied to patients without actually nerve block performed |
| G125 Block | Active comparator | Procedure: Ultrasound Guided Femoral Nerve Block, Drug: Bupivacaine 0.125% Injectable SolutionUltrasound Guided Femoral Nerve Block: 20ml Bupivacaine 0.125% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 15ml Saline solution. |
| G25 Block | Active comparator | Procedure: Ultrasound Guided Femoral Nerve Block, Drug: Bupivacaine 0.25% Injectable SolutionUltrasound Guided Femoral Nerve Block: 10ml Bupivacaine 0.25% Injectable Solution will be administered for femoral nerve block. 5ml %0,5 Bupivacaine will be diluted with 5ml Saline solution. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients who are scheduled for primary unilateral total knee arthroplasty under spinal anesthesia
- Patients who has informed consent for study
Key exclusion criteria (13 listed)
- Patient's refusal to participate
- Patients under 18 years of age
- Patients who are undergoing surgery with an anesthesia technique other than spinal anesthesia for any reason (general anesthesia, laryngeal mask application, etc.)
- Patients with known local anesthetic allergy
- Patients with Body mass index > 35
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 |
|---|---|---|
| Ultrasound Guided Femoral Nerve BlockAlso: Regional AnesthesiaFemoral nerve block will be applied post-operatively with guidance of USG and nerve stimulator | Procedure or surgery | G125 Block, G25 Block |
| DressingOnly dressing will be applied to related area to protect blindness between groups | Other | GCont |
| Bupivacaine 0.25% Injectable SolutionAlso: MarcainePerineural Injection | Drug | G25 Block |
| Bupivacaine 0.125% Injectable SolutionAlso: MarcainPerineural Injection | Drug | G125 Block |
Primary outcome
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 30th minute postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 1st hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 2nd hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 6th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 12th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 24th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
Post-operative pain assessed by Numeric Rating Scale (NRS)
Time frame: 48th hour postoperatively
Pain scores will be recorded as reported by the patient according to NRS
2 secondary outcomes
Ambulation Time
Time frame: 72 hours post-operatively
Opioid Consumption
Time frame: 48 hour post-operatively
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 10 Jul 2019.
- Background: PubMed 28273133Karlsen AP, Wetterslev M, Hansen SE, Hansen MS, Mathiesen O, Dahl JB. Postoperative pain treatment after total knee arthroplasty: A systematic review. PLoS One. 2017 Mar 8;12(3):e0173107. doi: 10.1371/journal.pone.0173107. eCollection 2017.
- Background: PubMed 28971169Tulgar S, Selvi O, Senturk O, Serifsoy TE, Sanel S, Meydaneri S. Evaluation of analgesic regimens in total knee arthroplasty, retrospective study. North Clin Istanb. 2017 Aug 25;4(2):124-130. doi: 10.14744/nci.2017.88598. eCollection 2017.
- Background: PubMed 29026354Thobhani S, Scalercio L, Elliott CE, Nossaman BD, Thomas LC, Yuratich D, Bland K, Osteen K, Patterson ME. Novel Regional Techniques for Total Knee Arthroplasty Promote Reduced Hospital Length of Stay: An Analysis of 106 Patients. Ochsner J. 2017 Fall;17(3):233-238.
- Individual participant dataSharing planned: No
Related trials for Anesthesia, Conduction
Not yet recruiting
Magnesium Sulphate as an Adjuvant in Combined Costoclavicular Block and Suprascapular Block Versus Interscalene Block for Ambulatory Shoulder Arthroscopy
Postoperative Pain, Shoulder Arthroscopy
Recruiting
Comparison of Spinal Anesthesia With Intrathecal Morphine Versus PENG Block With or Without Dexamethasone in Hip Arthroplasty
Arthropathy of Hip, Hip Osteoarthritis
Not yet recruiting
Lumbar Erector Spinae Plane Block Versus PENG Block for Hip Fracture Surgery
Femur Neck Fracture, Hip Fractures
Not yet recruiting
Comparison of Serratus Posterior Superior Intercostal Plane Block and Rhomboid Intercostal Block in Patients Undergoing Breast Cancer Surgery
Breast Cancer, Lymph Node Dissection
Not yet recruiting
Lumbar ESP Block Versus TAP Block for Postoperative Pain Control in Children Undergoing Open Inguinal Hernia Repair
Inguinal Hernia, Postoperative Pain
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.
Zeki T TEKGUL, Associate Professor study director
Izmir Bozyaka Training and Research Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ultrasound Guided Femoral Nerve Block, Dressing and Bupivacaine 0.25% Injectable Solution in people with Anesthesia, Conduction and Arthroplasty, Replacement, Knee, run by Bozyaka Training and Research Hospital at 1 site in Turkey (Türkiye).
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 2 inclusion and 13 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 10 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 Turkey (Türkiye). 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Post-operative pain assessed by Numeric Rating Scale (NRS) (time frame: 30th minute postoperatively). The study lists 7 primary outcomes in all. 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 NCT03623230, which also lists 3 linked publications.
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 10 Jul 2019.