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AzTrials

Anterior Cruciate Ligament ReconstructionPhase 4NCT01586806

Comparing Subsartorial Saphenous Nerve Blocks With and Without Dexamethasone for Anterior Cruciate Ligament Reconstruction

A Phase 4 study testing Bupivacaine Only, Bupivacaine with 1 mg of Dexamethasone and Bupivacaine with 4 mg of Dexamethasone in people with Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, run by Hospital for Special Surgery, New York at 1 site in United States.

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

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Read more about this study

Who is it for?
Ages 16 to 65 years
What is being tested?
Bupivacaine Only, Bupivacaine with 1 mg of Dexamethasone and Bupivacaine with 4 mg of Dexamethasone
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
195 participants
Where
1 siteUnited States
Study dates
Jul 2012to Dec 2014
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 16 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Patients undergoing ambulatory surgery for anterior cruciate ligament (ACL) reconstruction with a patella tendon autograft.
  • ASA I-III [American Society of Anesthesiologists (ASA) Physical Status classification system]
  • BMI < 35
  • Smokers included
  • Ages 16-65

Who cannot join

  • Patients on steroids or requiring stress dose steroids
  • BMI > 35
  • Patient refusal
  • Allergy to study medications,
  • NRS scores > 3 with frequent opioid use (including tramadol) prior to surgery-daily for greater than 3 weeks
  • Lower extremity neurological dysfunction
Show all 10Show fewer
  • Diabetic (NIDDM, insulin-dependent and/or oral hypoglycemic dependent)
  • Not in included age range (under 16 or over 65 years of age)
  • Contraindications to the use of dexamethasone
  • Non-English speaking patients. We will be using the Short Form 8 Health Survey, as well as the OR-SDS questionnaire (these are in English; any translations would have to be separately validated).

Trial locations and contacts

1 site in 1 country.

United States1 site

  • Hospital for Special Surgery

    New York, New York, 10021

Other trials in United States

About this study

Official title: Postoperative Analgesia Comparing Subsartorial Saphenous Nerve Block With and Without Dexamethasone in ACL Reconstruction

For patients undergoing Anterior Cruciate Ligament reconstruction surgery, the postoperative period can be a painful experience without adequate pain management. Hence the investigators propose a randomized controlled clinical study, investigating prolonged saphenous nerve blocks. Patients will be randomized to receive saphenous nerve blocks with or without dexamethasone, a corticosteroid used to prolong analgesia.

Depending on the randomized treatment assignment, patients may receive one of the following:

Read more
  1. 13 ml of 0.5% bupivacaine, a local anesthetic (no dexamethasone);
  2. 13 ml of 0.5% bupivacaine mixed with 1 mg of dexamethasone;
  3. 13 ml of 0.5% bupivacaine mixed with 4 mg of dexamethasone.

Patients will be followed postoperatively. Following admission to the recovery room, data collectors will ask patients to rate their pain on a scale of 0-10 until discharge. Data collectors will also record patient satisfaction, pain medication use and any side effects experienced (i.e. nausea and vomiting). Patients will then be contacted on postoperative days 1, 2 and 14 and asked questions about their general well-being.

Being tested
Bupivacaine Only, Bupivacaine with 1 mg of Dexamethasone, Bupivacaine with 4 mg of Dexamethasone
Keywords
Dexamethasone, Glucocorticoids, Physiological Effects of Drugs, Therapeutic Uses, Anterior Cruciate Ligament Reconstruction, Regional Anesthesia, nerve block, Ultrasonic Imaging, Post-Operative Complications: muscle weakness, pain, nausea and vomiting, Dexamethasone (as local anesthetic additive)
Medical subject headings
Pain, Nausea, Vomiting

What participants receive

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

  • Bupivacaine OnlyDrug

    This is the control treatment arm. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic).

  • Bupivacaine with 1 mg of DexamethasoneDrug

    This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 1 mg of dexamethasone. Total injection volume will be 15 ml.

  • Bupivacaine with 4 mg of DexamethasoneDrug

    This is one of two treatment arms. Patients will receive an ultrasound-guided saphenous nerve block, consisting of 13 ml of 0.5% bupivacaine (a local anesthetic), mixed with 4 mg of dexamethasone. Total injection volume will be 15 ml.

Study groups in NCT01586806
Study groupRoleWhat they receive
ControlPlacebo comparatorNot described
Receives: Drug: Bupivacaine Only
Dexamethasone 1 mgActive comparatorNot described
Receives: Drug: Bupivacaine with 1 mg of Dexamethasone
Dexamethasone 4 mgActive comparatorNot described
Receives: Drug: Bupivacaine with 4 mg of Dexamethasone

What is being measured

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

  1. Patient-perceived Duration of Analgesia

    After discharge, patients will be called and given instructions to help determine length of time of analgesia in the saphenous nerve distribution.

    Measured: Up to 2 days following surgery

Secondary outcomes (4)

  1. NRS (Numerical Rating Scale) Pain Scores

    Patients will be asked to rate, on a scale of 0-10, their pain while at rest. 0 indicates no pain, and 10 indicates the worst pain imaginable.

    Measured: Postoperative day 1

  2. Patient Satisfaction

    Patients will be asked to rate satisfaction on a scale of 0-10 (0=completely dissatisfied, 10=completely satisfied);

    Measured: Up to 2 days following surgery

  3. Postoperative Morphine Consumption

    Data collector will record how many opioids (i.e. Percocet, Vicodin) the patient has used since discharge.

    Measured: Up to 2 days following surgery

  4. Opioid-Related Side Effects (Drowsiness)

    Data collector will administer the Opioid-Related Distress Scale (OR-SDS) to determine if patients experience any opioid-related side effects (i.e. drowsiness). The OR-SDS score is on a scale of 0 to 4, with a higher number representing more severe symptoms.

    Measured: Up to 2 days following surgery

Timeline

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

  1. First posted27 Apr 2012 (estimated)
  2. Study startJul 2012
  3. Primary completionNov 2014
  4. Study completionDec 2014

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
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
195 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01586806
Sponsor's protocol ID
IRB #2012-002
Status last verified
Aug 2016
First submitted
25 Apr 2012
Last updated
28 Nov 2016
Data monitoring committee
Yes

Publications

  • Vieira PA, Pulai I, Tsao GC, Manikantan P, Keller B, Connelly NR. Dexamethasone with bupivacaine increases duration of analgesia in ultrasound-guided interscalene brachial plexus blockade. Eur J Anaesthesiol. 2010 Mar;27(3):285-8. doi: 10.1097/EJA.0b013e3283350c38.

    PubMed 20009936

  • Cummings KC 3rd, Napierkowski DE, Parra-Sanchez I, Kurz A, Dalton JE, Brems JJ, Sessler DI. Effect of dexamethasone on the duration of interscalene nerve blocks with ropivacaine or bupivacaine. Br J Anaesth. 2011 Sep;107(3):446-53. doi: 10.1093/bja/aer159. Epub 2011 Jun 14.

    PubMed 21676892

  • Portenoy RK, Thaler HT, Kornblith AB, Lepore JM, Friedlander-Klar H, Kiyasu E, Sobel K, Coyle N, Kemeny N, Norton L, et al. The Memorial Symptom Assessment Scale: an instrument for the evaluation of symptom prevalence, characteristics and distress. Eur J Cancer. 1994;30A(9):1326-36. doi: 10.1016/0959-8049(94)90182-1.

    PubMed 7999421

  • Apfelbaum JL, Gan TJ, Zhao S, Hanna DB, Chen C. Reliability and validity of the perioperative opioid-related symptom distress scale. Anesth Analg. 2004 Sep;99(3):699-709. doi: 10.1213/01.ANE.0000133143.60584.38.

    PubMed 15333398

  • Lundblad M, Kapral S, Marhofer P, Lonnqvist PA. Ultrasound-guided infrapatellar nerve block in human volunteers: description of a novel technique. Br J Anaesth. 2006 Nov;97(5):710-4. doi: 10.1093/bja/ael241. Epub 2006 Sep 26.

    PubMed 17005509

  • Akkaya T, Ersan O, Ozkan D, Sahiner Y, Akin M, Gumus H, Ates Y. Saphenous nerve block is an effective regional technique for post-menisectomy pain. Knee Surg Sports Traumatol Arthrosc. 2008 Sep;16(9):855-8. doi: 10.1007/s00167-008-0572-4. Epub 2008 Jun 24.

    PubMed 18574578

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine Only, Bupivacaine with 1 mg of Dexamethasone and Bupivacaine with 4 mg of Dexamethasone in people with Anterior Cruciate Ligament Reconstruction and Regional Anesthesia, Saphenous Nerve Block, run by Hospital for Special Surgery, New York 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 5 inclusion and 10 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 28 Nov 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 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 9 Jun 2016). 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?

Patient-perceived Duration of Analgesia (time frame: Up to 2 days following surgery). 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 NCT01586806, which also lists 6 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 28 Nov 2016.

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