Post-operative PainPhase 4NCT03706313
Genicular Nerve Block for Total Knee Arthroplasty
A Phase 4 study testing 15mL 0.25% bupivacaine, Genicular nerve block and Saline in people with Post-operative Pain, run by Duke University at 1 site in United States.
Trial summary
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Post-operative Pain
- What is being tested?
- 15mL 0.25% bupivacaine, Genicular nerve block and Saline
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Jan 2019to 22 Oct 2019
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Subjects scheduled for primary elective total knee arthroplasty
- American Society of Anesthesiologists Physical Status I-III
- BMI 18-40 kg/m2
Who cannot join
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to ropivacaine, bupivacaine or other local anesthetic
- Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
- Revision knee surgery
- Chronic opioid consumption (daily morphine equivalent of >30 mg for at least four weeks prior to surgery)
Show all 9Show fewer
- History of chronic pain
- History of psychiatric disorder
- History of diabetes mellitus
Trial locations and contacts
1 site in 1 country.
United States1 site
Duke University Hospital
Durham, North Carolina, 27705
About this study
Official title: A Comparison of Analgesic Efficacy of Ultrasound-guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
Read the detailed description
Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.
- Conditions
- Post-operative Pain
- Being tested
- 15mL 0.25% bupivacaine, Genicular nerve block, Saline
- Keywords
- Total knee replacement
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
15mL 0.25% bupivacaineDrug
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
Genicular nerve blockProcedure or surgery
The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described.
SalineDrug
Patients will be randomly assigned to either a genicular nerve block with bupivacaine or saline
| Study group | Role | What they receive |
|---|---|---|
| Genicular nerve block with bupivacaine | Active comparator | The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described. Receives: Drug: 15mL 0.25% bupivacaine; Procedure: Genicular nerve block |
| Genicular nerve block with saline | Placebo comparator | The ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves.
After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described. Receives: Procedure: Genicular nerve block; Drug: Saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid Consumption at 24 Hours Post-op
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
Measured: 24 hours after operation
Secondary outcomes (9)
Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Measured: Postoperative Day 1
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Measured: Postoperative day 1
Total Opioid Consumption Through 48 Hours
Total of all opioids consumed converted to oral morphine equivalents.
Measured: 48 hours
Opioid Consumption on Postoperative Day 7
Self-reported (by telephone questionnaire) opioid consumption in oral morphine equivalents on postoperative day 7
Measured: Postoperative day 7
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
The Numerical Rating Scale (NRS) is an 11-point numeric rating scale, with 0 representing "no pain" and 10 "unbearable pain." This scale demonstrates reliability and validity and is widely used to assess acute pain after surgery.
Measured: Postoperative day 7
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
The patient will be questioned by a member of the research team about how many times they were awoken by pain overnight.
Measured: Postoperative day 1
Patient Satisfaction With Pain Control at 24 h
Patient reported satisfaction with his/her pain control at 24 h on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Measured: 24 hours
Patient Satisfaction With Pain Control on Postoperative Day 7
Patient reported satisfaction with his/her pain control on postoperative day 7 on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied)
Measured: Postoperative day 7
20 Meter Walk Test Time Performed on Postoperative Day 1
This standardized test measures the time it takes for the participant to walk 20 meters at their usual walking pace. The 20-meter walk test is a physical function measure commonly used in clinical research studies and rehabilitation clinics to measure gait speed and monitor changes in patients' physical function over time.
Measured: On postoperative day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Oct 2018
- Study start15 Jan 2019
- Primary completion16 Oct 2019
- Study completion22 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Post-operative PainStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jeffrey Gadsden, MD, Principal investigator, Duke University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03706313
- Sponsor's protocol ID
- Pro00100879
- Status last verified
- Mar 2021
- First submitted
- 11 Oct 2018
- Last updated
- 1 Apr 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.
PubMed 34261807
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparison of Analgesic Efficacy of Ultrasound-guided Genicular Nerve Block Versus Saline Injection for Total Knee Replacement: a Prospective, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT03706313
- Acronym / sponsor ID
- Pro00100879
- Conditions
- Post-operative Pain
- Keywords
- Total knee replacement
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Study start
- 15 Jan 2019 (actual)
- Primary completion
- 16 Oct 2019 (actual)
- Study completion
- 22 Oct 2019 (actual)
- First posted
- 15 Oct 2018 (actual)
- Results
- Posted 5 Nov 2020
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study seeks to examine the analgesic efficacy of genicular nerve blocks for pain after total knee replacement.
Detailed description
Part of the way in which pain is controlled during total knee replacement surgery is through a nerve block. The investigators have developed an effective protocol for pain control after knee replacement, but know that many patients still experience pain around the knee after knee replacement. There are nerves around the knee that carry pain impulses from behind the knee. The investigators believe that placing numbing medicine around these nerves can help with pain in front of the knee after surgery, in addition to the standard nerve block placed for knee replacement surgery. This may result in taking less pain medication by mouth,and having less pain with movement. For this study, before the operation, either a placebo solution or the local anesthetic bupivacaine (a numbing solution) will be placed at three sites around the knee where these nerves reside. The investigators will evaluate how participants feel in recovery after surgery, during the stay in the hospital, and call at home one week after surgery. Knowing if numbing these nerves helps with pain after surgery will help us further refine our postoperative care plan for patients.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Genicular nerve block with bupivacaine | Active comparator | Drug: 15mL 0.25% bupivacaine, Procedure: Genicular nerve blockThe ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described. |
| Genicular nerve block with saline | Placebo comparator | Procedure: Genicular nerve block, Drug: SalineThe ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane (in-plane approach). Once satisfactory position of the needle time is confirmed, 5mL of a saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Subjects scheduled for primary elective total knee arthroplasty
- American Society of Anesthesiologists Physical Status I-III
- BMI 18-40 kg/m2
Key exclusion criteria (9 listed)
- Inability to cooperate with protocol
- Inability to understand or speak English
- Allergy to ropivacaine, bupivacaine or other local anesthetic
- Contraindication to peripheral nerve block (e.g. local infection, neurologic deficit or disorder, previous trauma or surgery to ipsilateral knee, etc.)
- Revision knee surgery
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 |
|---|---|---|
| 15mL 0.25% bupivacainePatients will be randomly assigned to either a genicular nerve block with bupivacaine or saline | Drug | Genicular nerve block with bupivacaine |
| Genicular nerve blockThe ultrasound-guided genicular nerve block will be performed at the site of the superior lateral, the superior medial, and the inferior medial genicular nerves. Color Doppler will be used to identify the arterial structures which serve as landmarks for the corresponding nerves. After skin local anesthetic infiltration, a 10 cm 21G insulated block needle will be inserted and aligned with the ultrasound scanning plane. Once satisfactory position of the needle is confirmed, 5mL of a solution containing 15 ml of 0.25% bupivacaine with 2mg dexamethasone or 5mL saline will be slowly injected. Spread of local anesthetic will be documented adjacent to the target nerve. This procedure will be performed at the site of the three genicular nerves described. | Procedure or surgery | Genicular nerve block with bupivacaine, Genicular nerve block with saline |
| SalinePatients will be randomly assigned to either a genicular nerve block with bupivacaine or saline | Drug | Genicular nerve block with saline |
Primary outcome
Opioid Consumption at 24 Hours Post-op
Time frame: 24 hours after operation
Opioid consumption documented in medical recorded will be converted to oral morphine equivalents.
9 secondary outcomes
Worst Pain Rating Score (NRS-11) at Rest on Postoperative Day 1
Time frame: Postoperative Day 1
Worst Pain Rating Score (NRS-11) With Movement on Postoperative Day 1
Time frame: Postoperative day 1
Total Opioid Consumption Through 48 Hours
Time frame: 48 hours
Opioid Consumption on Postoperative Day 7
Time frame: Postoperative day 7
Worst Pain Rating Score (NRS-11) on Postoperative Day 7
Time frame: Postoperative day 7
Sleep Quality Measured by Number of Times Awakened by Pain During the First Postoperative Night
Time frame: Postoperative day 1
Patient Satisfaction With Pain Control at 24 h
Time frame: 24 hours
Patient Satisfaction With Pain Control on Postoperative Day 7
Time frame: Postoperative day 7
20 Meter Walk Test Time Performed on Postoperative Day 1
Time frame: On postoperative day 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 34261807Rambhia M, Chen A, Kumar AH, Bullock WM, Bolognesi M, Gadsden J. Ultrasound-guided genicular nerve blocks following total knee arthroplasty: a randomized, double-blind, placebo-controlled trial. Reg Anesth Pain Med. 2021 Oct;46(10):862-866. doi: 10.1136/rapm-2021-102667. Epub 2021 Jul 14.
- 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.
Jeffrey Gadsden, MD principal investigator
Duke University
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 15mL 0.25% bupivacaine, Genicular nerve block and Saline in people with Post-operative Pain, run by Duke University at 1 site in United States.
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 3 inclusion and 9 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 1 Apr 2021. 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 United States. 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?
Yes. Results are posted in the registry (first posted 5 Nov 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Opioid Consumption at 24 Hours Post-op (time frame: 24 hours after operation). 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 NCT03706313, 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 1 Apr 2021.