Anesthesia; ReactionPhase 4NCT02355093
Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
A Phase 4 study testing adductor canal block (ACB), Femoral nerve block (FNB) and ropivacaine in people with Anesthesia; Reaction, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
Trial summary
This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically，especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Anesthesia; Reaction
- What is being tested?
- adductor canal block (ACB), Femoral nerve block (FNB) and ropivacaine
- Type of treatment
- Injection or infusion, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- No sites listed yet
- Study dates
- Jul 2014to Oct 2015
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- ASA Ⅰ-Ⅲ
- Anterior Cruciate Ligament Reconstruction
Who cannot join
- patient refusal
- chronic use of opioids
- coagulation disorders
- infection at the puncture site
- allergic to anaesthetic
- preexisting neurological disorders
- communication difficulties
About this study
This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically，especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.
Read the detailed description
Forty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ（no limitation of age and gender）are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically. Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block. Patients are going to be visited for follow-up on the day of surgery and in the following two days. Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.
- Conditions
- Anesthesia; Reaction
- Being tested
- adductor canal block (ACB), Femoral nerve block (FNB), ropivacaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
adductor canal block (ACB)Procedure or surgery
We performed an ultrasound survey at the medial part of the thigh，the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours.
Femoral nerve block (FNB)Procedure or surgery
the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle，an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours.
ropivacaineDrug
| Study group | Role | What they receive |
|---|---|---|
| adductor canal block (ACB) | Experimental | We performed an ultrasound survey at the medial part of the thigh，the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours. Receives: Procedure: adductor canal block (ACB); Drug: ropivacaine |
| Femoral nerve block (FNB) | Active comparator | the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle，an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours. Receives: Procedure: Femoral nerve block (FNB); Drug: ropivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
quadriceps muscle strength, as measured by handheld dynamometer.
Measured: 3 days
Secondary outcomes (1)
pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2015 (estimated)
- Study startJul 2014
- Primary completionMar 2015 (estimated)
- Study completionOct 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anesthesia; ReactionStudies 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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daqiang Zhao, Shanghai Jiao Tong University Affiliated Sixth People's Hospital
- Investigators
- Daqiang Zhao, Master, Principal investigator, Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02355093
- Sponsor's protocol ID
- ACB vs FNB
- Status last verified
- Jan 2015
- First submitted
- 28 Jan 2015
- Last updated
- 4 Feb 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Adductor Canal Block Versus Femoral Nerve Block for Analgesia After Anterior Cruciate Ligament Reconstruction Arthroscopically
- ClinicalTrials.gov ID
- NCT02355093
- Acronym / sponsor ID
- ACB vs FNB
- Conditions
- Anesthesia; Reaction
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Shanghai Jiao Tong University Affiliated Sixth People's HospitalUniversity, hospital or other
- Study start
- Jul 2014
- Primary completion
- Mar 2015 (estimated)
- Study completion
- Oct 2015 (estimated)
- First posted
- 4 Feb 2015 (estimated)
- 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.
This study aims to compare continuous femoral nerve block with adductor canal block after anterior cruciate ligament reconstruction arthroscopically，especially in the effect on quadriceps strength; and to evaluate which regional anesthesia is more ideal for the patients postoperatively.
Detailed description
Forty patients with American Society of Anesthesiologists（ASA） Ⅰ-Ⅲ（no limitation of age and gender）are randomized to receive either a continuous adductor canal block(ACB) or a femoral nerve block(FNB) via a catheter (a continuous infusion of 0.2% ropivacaine, 5 mL/h for 48 hours)in the PACU immediately after the anterior cruciate ligament reconstruction arthroscopically. Patients were under general anesthesia during the operation and received a femoral nerve block with 0.25% ropivacaine 10ml before the surgery.Both groups will receive postoperatively IV patient controlled analgesia (PCA) with morphine (bolus 0.8mg,lock-out time 15 minutes, background infusion 2ml/h)beside the continuous nerve block. Patients are going to be visited for follow-up on the day of surgery and in the following two days. Quadriceps strength is assessed with the displacement of patella.VAS at rest time、degree of knee flexion、VAS at 45°flexion of the knee、dose of opioids、whether the patient has sleep disturbance are also recorded.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| adductor canal block (ACB) | Experimental | Procedure: adductor canal block (ACB), Drug: ropivacaineWe performed an ultrasound survey at the medial part of the thigh，the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours. |
| Femoral nerve block (FNB) | Active comparator | Procedure: Femoral nerve block (FNB), Drug: ropivacainethe catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle，an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (2 listed)
- ASA Ⅰ-Ⅲ
- Anterior Cruciate Ligament Reconstruction
Key exclusion criteria (7 listed)
- patient refusal
- chronic use of opioids
- coagulation disorders
- infection at the puncture site
- allergic to anaesthetic
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 |
|---|---|---|
| adductor canal block (ACB)We performed an ultrasound survey at the medial part of the thigh，the needle is introduced in-plane and 2 to 3 mL of saline is used to ensure correct placement of the needle in the vicinity of the saphenous nerve in the adductor canal,the catheter is introduced and advanced 1 to 2 cm beyond the tip of the needle.The study medication is administered as an infusion of 0.2% ropivacaine at a rate of 5mL/h during the next 48 hours. | Procedure or surgery | adductor canal block (ACB) |
| Femoral nerve block (FNB)the catheter is inserted in-plane with the probe parallel to the inguinal crease, to obtain a short-axis view of the nerve. The correct needle placement is confirmed by injecting 2 to 3 mL of saline to cause tissue expansion below the iliac fascia, lateral to the femoral artery, and in the vicinity of the femoral nerve. The catheter is introduced 1 to 2 cm beyond the tip of the needle，an infusion of 0.2% ropivacaine at a rate of 5mL/h is administered during the next 48 hours. | Procedure or surgery | Femoral nerve block (FNB) |
| ropivacaine | Drug | Femoral nerve block (FNB), adductor canal block (ACB) |
Primary outcome
quadriceps muscle strength, as measured by handheld dynamometer.
Time frame: 3 days
1 secondary outcome
pain at rest time and during flexion of the knee, as measured by visual analog score(VAS).
Time frame: 3 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2015.
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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.
Daqiang Zhao, Master principal investigator
Shanghai Jiaotong University Affiliated Sixth People's Hospital Shanghai,China
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing adductor canal block (ACB), Femoral nerve block (FNB) and ropivacaine in people with Anesthesia; Reaction, run by Shanghai Jiao Tong University Affiliated Sixth People's Hospital.
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 7 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: status not confirmed, as of the sponsor's last update on 4 Feb 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
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?
Results are not available in the source record.
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?
quadriceps muscle strength, as measured by handheld dynamometer. (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Feb 2015.