NCT02697955

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for phase_4

Timeline
Completed

Started Jun 2016

Shorter than P25 for phase_4

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

February 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

March 3, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

June 21, 2016

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 28, 2017

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 28, 2017

Completed
Last Updated

March 27, 2017

Status Verified

September 1, 2016

Enrollment Period

8 months

First QC Date

February 22, 2016

Last Update Submit

March 24, 2017

Conditions

ArthrosisArthritis

Outcome Measures

Primary Outcomes (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.

    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)

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

    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.

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

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

Study Arms (2)

Bupivacaine-epinephrine

EXPERIMENTAL

10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine

Drug: Bupivacaine-epinephrine

Placebo

PLACEBO COMPARATOR

10 ml normal saline water (sodium chloride solution, 0,9%)

Other: Placebo

Interventions

Bupivacaine-epinephrineDRUG

50 mg bupivacaine and 50 μg adrenalin

Also known as: Marcain-adrenalin (combination drug), Marketing Authorisation Holder: AstraZeneca, Marketing Authorisation number: 10213
Bupivacaine-epinephrine
PlaceboOTHER

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

Also known as: Sodium chloride solution
Placebo

Eligibility Criteria

Age18 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Anesthesiology, Aarhus University Hospital

Aarhus, 8000, Denmark

Location

Related Publications (9)

  • 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.

    PMID: 23630434BACKGROUND

  • 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.

    PMID: 21169609BACKGROUND

  • 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.

    PMID: 14570643BACKGROUND

  • 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.

    PMID: 23788076BACKGROUND

  • 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.

    PMID: 24535194BACKGROUND

  • 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.

    PMID: 24306699BACKGROUND

  • 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.

    PMID: 25851020BACKGROUND

  • 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.

    PMID: 26079358BACKGROUND

  • 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.

    PMID: 29667940DERIVED

MeSH Terms

Conditions

OsteoarthritisArthritis

Interventions

Drug CombinationsSodium Chloride

Condition Hierarchy (Ancestors)

Joint DiseasesMusculoskeletal DiseasesRheumatic Diseases

Intervention Hierarchy (Ancestors)

Pharmaceutical PreparationsChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Officials

  • Thomas Fichtner Bendtsen, MD, phD

    Department of Anesthesiology, Aarhus University Hospital

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

February 22, 2016

First Posted

March 3, 2016

Study Start

June 21, 2016

Primary Completion

February 28, 2017

Study Completion

February 28, 2017

Last Updated

March 27, 2017

Record last verified: 2016-09

Locations

DK(1)