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Pain, PostoperativePhase 4NCT02411890

Postoperative Pain Between ACB and FNB After ACLR

A Phase 4 study testing Adductor canal block (active) and Femoral nerve block (active) in people with Pain, Postoperative and Knee Arthroscopy, run by Thammasat University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The aim of this study is to compare the efficacy in pain relief within 24 hours between adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction with hamstring graft. Read more about this study

Who is it for?
Ages 15 to 80 years
What is being tested?
Adductor canal block (active) and Femoral nerve block (active)
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
60 participants
Where
1 siteThailand
Study dates
Feb 2015to Dec 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 15 to 80 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • arthroscopic anterior cruciate ligament reconstruction with hamstring graft at Thammasat University Hospital.
  • age 15-80 years
  • ASA class I-III

Who cannot join

  • refuse to participate the study
  • morbid obesity (BMI ≥ 35 kg.m2)
  • allergic to any medication in the study
  • chronic opioid use or abuse
  • lower extremity neurological dysfunction
  • patients who cannot cooperate and assess pain score themselves.

Trial locations and contacts

1 site in 1 country.

Thailand1 site
  • Thammasat University Hospital

    Khlong Luang, Changwat Pathum Thani, 12120

Other trials in Thailand

About this study

Official title: The Comparison of Postoperative Analgesia Between Adductor Canal Block and Femoral Nerve Block After Arthroscopic ACL Reconstruction With Hamstring Graft: A Randomized Controlled Trial

The aim of this study is to compare the efficacy in pain relief within 24 hours between adductor canal block and femoral nerve block after anterior cruciate ligament reconstruction with hamstring graft.

Read the detailed description

After approval from institutional ethic committees, Thammasat University Hospital, patients who meet the eligible criteria will be asked for informed consent. Randomization will be performed by computerization with varied block sizes (4 and 6), and the sequence of randomization will be concealed by sealed envelopes. Once given informed consent, the investigator opened the sealed envelope, which randomized the patient to the adductor canal block group (ACB), or the femoral nerve block group (FNB).

The day before surgery day, patients who meet the eligible criteria will ask for the informed consent from blinded research assistant. They will obtain patients' demographic data, preoperative pain scores, and quadriceps strength. They will be recommended how to evaluate pain score and use the patient-controlled analgesia.

In the block room, patients will be sedated with midazolam 2-3 mg intravenously. The nerve block will be performed before spinal anesthesia by unblinded anesthesiologists. During block, the patients will be blinded by sham block. In ACB group, patients will receive sham block of femoral nerve at inguinal area, and then ACB will be performed, while in FNB group, patients will receive FNB, and then sham block will be performed in the mid-femoral area.

After standard monitored, the saphenous nerve will be blocked in the ACB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) with nerve stimulator (Payunk®) at midfemoral level. When the needle tip is positioned, the nerve stimulator is turned on and set to deliver a current of 0.5 mA at a frequency of 2 Hz and pulse duration of 0.1 ms. The presence of a quadriceps muscle twitch, if elicited, will be recorded, and the needle was re-positioned until the muscle twitch disappeared. Then, 0.5% levobupivacaine with adrenaline 5 µg/ml 15 ml will be injected.

The femoral nerve block is also performed in the FNB group under ultrasound guidance using linear probe (9 mHz, GE Healthcare®) and nerve stimulator (Payunk®). With ultrasound guidance, the femoral nerve is identified in femoral triangle near to femoral artery, and when the needle tip is in proper position in the ultrasound image, the nerve stimulator is used to confirm, the presence of quadriceps twitching at the current less than 0.5 mA, and the absence of quadriceps twitching at the current more than 0.2 mA. After that, 30 ml of 0.25% levobupivacaine with adrenaline 5 µg/ml is injected.

During performing both blocks, patients' eyes will be closed. The sham block involves an ultrasound survey at inguinal area in ACB group and mid-femoral area in FNB group, stump needle is marked at the injection site but not penetrating skin. 10 or 30 mL of saline depending on type of sham block will be injected into an absorbing cloth. Opaque plaster will be used for both block sites.

Fifteen minutes after ACB or FNB, the success of block is evaluated by blinded investigators. Loss of sensation at the either infrapatellar region or medial of calf will be tested every 5 mins. Fail block is documented, if there is no loss of sensation greater than 30 mins after block performed. Then, spinal anesthesia is performed with 0.5% isobaric or heavy marcaine 2.5-3.5 ml.

In the operative room, patients will receive cefazolin 1 gm, and ketorolac 30 mg intravenously before skin incision. Tourniquet 350 mmHg will be applied on operated thigh and limited time is no longer than 120 mins. Drain will be inserted, and knee brace or Jone's bandage will be applied postoperatively in all patients.

Postoperatively, all patients received disposable patient-controlled analgesia (PCA) for parenteral morphine as needed to control VAS less than 4 with setting PCA dose 2.5 mg (patients ≤ 60 years) 2 mg (patients ≥ 60 years), no basal rate, lock out 5 mins. Postoperative analgesic regimen are ketorolac 30 mg IV 8 hours after intraoperative dose, Etoricoxib (90) 1 tab oral once daily, paracetamol (500) 1 tab oral every 6 hours, reparil 2 tab oral tid, and myonal 1 tab oral tid. Drain will be removed in postoperative day 1 by surgeons and patients will be allowed to walk with crutches after drain removes Outcomes The primary outcome is VAS at 24 hours during activity . The patients will be instructed in the use of the 0 to 100 mm visual analogue scale (VAS) with 0 and 100 mm referring to 'no pain' and 'worst pain imaginable', respectively, at inclusion to the study.

VAS also assessed at 4 hour after surgery and then every 4 hours, at rest, and activity until 24 hours.

Total opioid consumption in first 24 hours and first time that patient pressing PCA is also recorded. Opioid side effects (nausea vomiting, pruritus, respiratory depression, urinary retention) will be recorded. Nausea vomiting, and pruritus will be recorded as 0-2 scales: 0=none, 1=mild symptom but no need treatment, 2=severe symptom and need medical treatment). Respiratory depression will be recorded as yes (respiratory rate≤8 per minute), and no. Urinary retention will be measured as yes (need urinary catheterization), and no.

Quadriceps strength will be assessed as maximum voluntary isometric contraction (MVIC) preoperatively, 8-12, and 24 hours postoperatively with handheld dynamometer (HHD, Lafayette Instrument, Lafayette, IN) which has been already calibrated. The strength will be evaluated by blinded research assistant, and use the Velcro strap to fix the dynamometer to reduce interrater variability. The patients will sit with 60 degree knee flexion, with attach the HHD at 5 cm above transmalleolar axis. The patients will be asked for extend their knee as forcefully as possible in 3 seconds with the instruction of the assessors (push-push-push-pause). The strength will be measured for 3 times and the maximum value will be used. Then, the maximal torque will be calculated by multiplying the maximal force (newtons) with the distance between femoral condyle and HHD (meters). After each contraction, the level of pain is quantified with use of a 0-100 point VAS.

Timing for readiness for hospital discharge within 24 hours will also be recorded. The criteria of readiness hospital discharge is patient is alert and responsive to questioning, show acceptable pain and nausea control, able to urinate, able to walk with crutches. The actual time of discharge and the reason of delayed discharge will also be recorded. All outcomes are assessed by blinded outcome assessors, who do not involved in other parts of this study.

Statistical analysis Continuous data will be presented as mean (SD) or median (IQR) as appropriate, and categorical data will be presented as frequency (percentage).The comparison between continuous data will be performed by t-test or Mann-Whitney U test depending on the distribution of data. Pain scores in first 24 hours were compared after calculating the area under the curve for the interval 2 to 24 hours.Categorical variables will be compared by chi-square or Fischer-exact test. P values less than 0.05 shows statistical significance. Statistical analysis will be performed by using STATA (13.0) software.

Being tested
Adductor canal block (active), Femoral nerve block (active), Femoral nerve block (sham block), Adductor canal block (sham block)
Keywords
postoperative pain, femoral nerve block, adductor canal block, anterior cruciate ligament reconstruction
Medical subject headings
Pain, Postoperative

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Adductor canal block (active)Procedure or surgery

    adductor canal block: single injection, 0.5% levobupivacaine 15 ml with adrenaline 5 µg/ml, ultrasound guidance with nerve stimulator

  • Femoral nerve block (active)Procedure or surgery

    femoral nerve block: single injection, 0.25% levobupivacaine 30 ml with adrenaline 5 µg/ml, ultrasound guidance with nerve stimulator

  • Femoral nerve block (sham block)Procedure or surgery

    30 mL of normal saline injected into absorbing cloth through stump needle at the inguinal area but not penetrating skin, ultrasound guidance and nerve stimulator with percutaneous electronic guidance to create quadriceps contraction before injection

  • Adductor canal block (sham block)Procedure or surgery

    30 mL of normal saline injected into absorbing cloth through stump needle at the midfemoral area but not penetrating skin, ultrasound guidance and nerve stimulator with percutaneous electronic guidance without muscle contraction

Study groups in NCT02411890
Study groupRoleWhat they receive
Adductor canal blockExperimentalAdductor canal block (active) + Femoral nerve block (sham block)
Receives: Procedure: Adductor canal block (active); Procedure: Femoral nerve block (sham block)
Femoral nerve blockActive comparatorFemoral nerve block (active) + Adductor canal block (sham block)
Receives: Procedure: Femoral nerve block (active); Procedure: Adductor canal block (sham block)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Pain score (VAS) during activity

    Pain score during activity measured on Visual Analog Scale postoperative 24 hours. Adductor canal block VS Femoral nerve block

    Measured: 24 hours postoperative

Secondary outcomes (9)
  1. Opioid consumption

    Intravenous morphine consumption (milligrams) during 0-24 hours from patient controlled analgesia. Adductor canal block vs Femoral nerve blockanalgesia.

    Measured: 0-24 hours postoperative

  2. Pain score (VAS) at rest

    Adductor canal block vs Femoral nerve block

    Measured: 4, 8, 12, 16, 20, 24 hours postoperative

  3. Pain score (VAS) at activity

    Adductor canal block vs Femoral nerve block

    Measured: 4, 8, 12, 16, 20 hours postoperative, and during quadriceps strength testing

  4. duration (hours) after surgery-first time that patients pressing PCA

    Adductor canal block vs Femoral nerve block

    Measured: 0-24 hours postoperative

  5. The reduction of quadriceps strength from preoperative period both knees

    Quadriceps strength measured on the maximum voluntary isometric contraction with hand-held dynamometer. Adductor canal block vs Femoral nerve block

    Measured: 8-12, 24 hours

  6. Postoperative nausea and vomiting

    Rating scale 0-2. Adductor canal block vs Femoral nerve block

    Measured: 0-24 hours postoperative

  7. Postoperative pruritus or rash

    Rating scale 0-2. Adductor canal block vs Femoral nerve block

    Measured: 0-24 hours postoperative

  8. Postoperative urinary retention

    Dichotomous outcome (Yes/No). Adductor canal block vs Femoral nerve block

    Measured: 0-24 hours postoperative

  9. Postoperative respiratory depression

    Dichotomous outcome (Yes/No). Adductor canal block vs Femoral nerve block

    Measured: 0-24 hours postoperative

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted8 Apr 2015 (estimated)
  2. Study startFeb 2015
  3. Primary completionDec 2015
  4. Study completionDec 2015

Resources

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
Triple blind
Who is masked
Participant, Care provider, Outcomes assessor
Enrolment
60 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02411890
Sponsor's protocol ID
MTU-EC-AN-6-014/58
Status last verified
Jan 2016
First submitted
29 Mar 2015
Last updated
20 Jan 2016
Results posted
No
Data monitoring committee
No

Publications

  • Beck PR, Nho SJ, Balin J, Badrinath SK, Bush-Joseph CA, Bach BR Jr, Hayden JK. Postoperative pain management after anterior cruciate ligament reconstruction. J Knee Surg. 2004 Jan;17(1):18-23. doi: 10.1055/s-0030-1247142.

    PubMed 14971669
  • Chisholm MF, Bang H, Maalouf DB, Marcello D, Lotano MA, Marx RG, Liguori GA, Zayas VM, Gordon MA, Jacobs J, YaDeau JT. Postoperative Analgesia with Saphenous Block Appears Equivalent to Femoral Nerve Block in ACL Reconstruction. HSS J. 2014 Oct;10(3):245-51. doi: 10.1007/s11420-014-9392-x. Epub 2014 Jun 7.

    PubMed 25264441
  • Hanson NA, Derby RE, Auyong DB, Salinas FV, Delucca C, Nagy R, Yu Z, Slee AE. Ultrasound-guided adductor canal block for arthroscopic medial meniscectomy: a randomized, double-blind trial. Can J Anaesth. 2013 Sep;60(9):874-80. doi: 10.1007/s12630-013-9992-9. Epub 2013 Jul 3.

    PubMed 23820968

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Adductor canal block (active) and Femoral nerve block (active) in people with Pain, Postoperative and Knee Arthroscopy, run by Thammasat University at 1 site in Thailand.

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 6 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 20 Jan 2016. 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 Thailand. 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.

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?

Pain score (VAS) during activity (time frame: 24 hours postoperative). 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 NCT02411890, 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 20 Jan 2016.

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Postoperative Pain Between ACB and FNB After ACLR | AzTrials