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ArthrosisPhase 4NCT02697955

The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

A Phase 4 study testing Bupivacaine-epinephrine in people with Arthrosis and Arthritis, run by University of Aarhus at 1 site in Denmark.

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 study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery. Read more about this study

Who is it for?
Ages 18 to 85 years
Conditions the study is for
Arthrosis, Arthritis
What is being tested?
Bupivacaine-epinephrine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
18 participants
Where
1 siteDenmark
Study dates
21 Jun 2016to 28 Feb 2017
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 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Elective ankle or hind foot surgery either: (1) total ankle arthroplasty, (2) ankle arthrodesis (3) subtalar arthrodesis or (4) triple arthrodesis
  • Age ≥ 18
  • American Society of Anaesthesiology Classification I-III
  • Informed consent both orally and in writing after the patient has fully understood the protocol and its limitations.

Who cannot join

  • Communication problems or dementia
  • Allergies to any medical product used in the study
  • Neuropathy of the sciatic or femoral nerve prior to the operation
  • Morbus Charcot-Marie-Tooth disease, diabetic neuropathy, peripheral vascular disease
  • Daily use of opioids
  • Coagulation disorders
  • Infection at the site of injection or systemic infection

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Department of Anesthesiology, Aarhus University Hospital

    Aarhus, 8000

Other trials in Denmark

About this study

The study investigates the effect of a ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Read the detailed description

Major ankle and hind foot surgery causes intense postoperative pain. Implementation of continuous sciatic catheters has been a great success in reducing postoperative pain following these operations, but despite an effective sciatic catheter patients still report moderate to severe pain from the anteromedial side of the ankle. According to cadaver dissection studies the saphenous nerve innervates the anterior and medial parts of the ankle and talonavicular joint, and even though a saphenous block is standard procedure in many departments of anesthesiology worldwide, scientific evidence regarding the effect of the saphenous block on postoperative pain is lacking.

This study investigates the effect of a selective, ultrasound-guided subsartorial saphenous block on postoperative pain following major ankle and hind foot surgery.

Conditions
Arthrosis, Arthritis
Being tested
Bupivacaine-epinephrine, Placebo
Medical subject headings
Osteoarthritis, Arthritis

What participants receive

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

  • Bupivacaine-epinephrineDrug

    Also called Marcain-adrenalin (combination drug), Marketing Authorisation Holder: AstraZeneca, Marketing Authorisation number: 10213

    50 mg bupivacaine and 50 μg adrenalin

  • PlaceboOther

    Also called Sodium chloride solution

    9 mg sodium chloride pr. ml (0,9 %)

Study groups in NCT02697955
Study groupRoleWhat they receive
Bupivacaine-epinephrineExperimental10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine
Receives: Drug: Bupivacaine-epinephrine
PlaceboPlacebo comparator10 ml normal saline water (sodium chloride solution, 0,9%)
Receives: Other: Placebo

What is being measured

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

  1. Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)

    Pain scores evaluated using NRS (numeric rating scale). Significant pain is defined as NRS > 3 from the anterior and/medial side of the ankle joint. In case of significant pain, patients receive a rescue saphenous block with 10 ml bupivacaine-adrenaline.

    Measured: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of surgery.

Secondary outcomes (2)

  1. Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)

    Test of nociceptive response in the cutaneous innervation area of the infrapatellar branch (branch of the saphenous nerve). The test is performed in an area from the medial femoral condyle to the midline between the apex of patella and tibial tuberosity.

    Measured: At the time point when the patients report a change to significant pain during the observation period. In case of no significant pain during the observation period, sensory testing is conducted at t = 120 min.

  2. Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)

    Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.

    Measured: Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)

Timeline

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

  1. First posted3 Mar 2016 (estimated)
  2. Study start21 Jun 2016
  3. Primary completion28 Feb 2017
  4. Study completion28 Feb 2017

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
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
18 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02697955
Sponsor's protocol ID
ProtokolSB2
Status last verified
Sep 2016
First submitted
22 Feb 2016
Last updated
27 Mar 2017
Results posted
No
Data monitoring committee
Yes
Individual data sharing
Undecided

Publications

  • Clendenen SR, Whalen JL. Saphenous nerve innervation of the medial ankle. Local Reg Anesth. 2013 Mar 6;6:13-6. doi: 10.2147/LRA.S42603. Print 2013.

    PubMed 23630434

  • Blumenthal S, Borgeat A, Neudorfer C, Bertolini R, Espinosa N, Aguirre J. Additional femoral catheter in combination with popliteal catheter for analgesia after major ankle surgery. Br J Anaesth. 2011 Mar;106(3):387-93. doi: 10.1093/bja/aeq365. Epub 2010 Dec 17.

    PubMed 21169609

  • White PF, Issioui T, Skrivanek GD, Early JS, Wakefield C. The use of a continuous popliteal sciatic nerve block after surgery involving the foot and ankle: does it improve the quality of recovery? Anesth Analg. 2003 Nov;97(5):1303-1309. doi: 10.1213/01.ANE.0000082242.84015.D4.

    PubMed 14570643

  • Chen J, Lesser J, Hadzic A, Resta-Flarer F. The importance of the proximal saphenous nerve block for foot and ankle surgery. Reg Anesth Pain Med. 2013 Jul-Aug;38(4):372. doi: 10.1097/AAP.0b013e318295596a. No abstract available.

    PubMed 23788076

  • Kalthur SG, Sumalatha S, Nair N, Pandey AK, Sequeria S, Shobha L. Anatomic study of infrapatellar branch of saphenous nerve in male cadavers. Ir J Med Sci. 2015 Mar;184(1):201-6. doi: 10.1007/s11845-014-1087-2. Epub 2014 Feb 18.

    PubMed 24535194

  • Kerver AL, Leliveld MS, den Hartog D, Verhofstad MH, Kleinrensink GJ. The surgical anatomy of the infrapatellar branch of the saphenous nerve in relation to incisions for anteromedial knee surgery. J Bone Joint Surg Am. 2013 Dec 4;95(23):2119-25. doi: 10.2106/JBJS.L.01297.

    PubMed 24306699

  • Fisker AK, Iversen BN, Christensen S, Linde F, Nielsen KK, Borglum J, Bendtsen TF. Combined saphenous and sciatic catheters for analgesia after major ankle surgery: a double-blinded randomized controlled trial. Can J Anaesth. 2015 Aug;62(8):875-82. doi: 10.1007/s12630-015-0379-y. Epub 2015 Apr 8.

    PubMed 25851020

  • Bendtsen TF, Moriggl B, Chan V, Borglum J. Basic Topography of the Saphenous Nerve in the Femoral Triangle and the Adductor Canal. Reg Anesth Pain Med. 2015 Jul-Aug;40(4):391-2. doi: 10.1097/AAP.0000000000000261. No abstract available.

    PubMed 26079358

  • Bjorn S, Wong WY, Baas J, Nielsen KK, Borglum J, Hauritz RW, Bendtsen TF. The Importance of the Saphenous Nerve Block for Analgesia Following Major Ankle Surgery: A Randomized, Controlled, Double-Blind Study. Reg Anesth Pain Med. 2018 Jul;43(5):474-479. doi: 10.1097/AAP.0000000000000764.

    PubMed 29667940

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Bupivacaine-epinephrine in people with Arthrosis and Arthritis, run by University of Aarhus at 1 site in Denmark.

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 4 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: finished, as of the sponsor's last update on 27 Mar 2017. 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 Denmark. 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?

Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain) (time frame: Arrival at the Perioperative Section (within 30 minutes after surgery) and at t = 30 min, t = 45 min, t = 60 min, t = 75 min, t = 90 min, t = 105 min, t = 120. The beginning of the observation period (t0) is the registered time for the end of 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 NCT02697955, which also lists 9 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 27 Mar 2017.

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