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

Primary Purpose

Arthrosis, Arthritis

Status
Completed
Phase
Phase 4
Locations
Denmark
Study Type
Interventional
Intervention
Bupivacaine-epinephrine
Placebo
Sponsored by
University of Aarhus
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Arthrosis

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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

Sites / Locations

  • Department of Anesthesiology, Aarhus University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Bupivacaine-epinephrine

Placebo

Arm Description

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

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
February 22, 2016
Last Updated
March 24, 2017
Sponsor
University of Aarhus
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1. Study Identification

Unique Protocol Identification Number
NCT02697955
Brief Title
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
Official Title
The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
September 2016
Overall Recruitment Status
Completed
Study Start Date
June 21, 2016 (Actual)
Primary Completion Date
February 28, 2017 (Actual)
Study Completion Date
February 28, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Aarhus

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Arthrosis, Arthritis

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
18 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Bupivacaine-epinephrine
Arm Type
Experimental
Arm Description
10 mL of 5 mg/mL bupivacaine with 5 μg/mL epinephrine = 50 mg bupivacaine and 50 μg epinephrine
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
10 ml normal saline water (sodium chloride solution, 0,9%)
Intervention Type
Drug
Intervention Name(s)
Bupivacaine-epinephrine
Other Intervention Name(s)
Marcain-adrenalin (combination drug), Marketing Authorisation Holder: AstraZeneca, Marketing Authorisation number: 10213
Intervention Description
50 mg bupivacaine and 50 μg adrenalin
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
Sodium chloride solution
Intervention Description
9 mg sodium chloride pr. ml (0,9 %)
Primary Outcome Measure Information:
Title
Frequency of patients who experience significant pain at rest (change from no significant pain to significant pain)
Description
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.
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.
Secondary Outcome Measure Information:
Title
Sensory testing, infrapatellar branch (nociception is tested using a standardized Neuropen)
Description
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.
Time Frame
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.
Title
Sensory testing, sciatic nerve (nociception is tested using a standardized Neuropen)
Description
Test of nociceptive response in the sciatic cutaneous innervation area to confirm full sensory block of the sciatic nerve.
Time Frame
Sensory test is conducted at arrival at the Perioperative Section (within 30 minutes after surgery)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Fichtner Bendtsen, MD, phD
Organizational Affiliation
Department of Anesthesiology, Aarhus University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Department of Anesthesiology, Aarhus University Hospital
City
Aarhus
ZIP/Postal Code
8000
Country
Denmark

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
23630434
Citation
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.
Results Reference
background
PubMed Identifier
21169609
Citation
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.
Results Reference
background
PubMed Identifier
14570643
Citation
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. Erratum In: Anesth Analg. 2003 Dec;97(6):1557.
Results Reference
background
PubMed Identifier
23788076
Citation
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.
Results Reference
background
PubMed Identifier
24535194
Citation
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.
Results Reference
background
PubMed Identifier
24306699
Citation
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.
Results Reference
background
PubMed Identifier
25851020
Citation
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.
Results Reference
background
PubMed Identifier
26079358
Citation
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.
Results Reference
background
PubMed Identifier
29667940
Citation
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.
Results Reference
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The Effect of Subsartorial Saphenous Block on Postoperative Pain Following Major Ankle and Hind Foot Surgery

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