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Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery

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ClinicalTrials.gov Identifier: NCT03332316
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : April 24, 2019
Sponsor:
Information provided by (Responsible Party):
Tampere University Hospital

Tracking Information
First Submitted Date  ICMJE October 26, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date April 24, 2019
Actual Study Start Date  ICMJE November 2, 2017
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
First need of opiate [ Time Frame: 48 hours ]
Time after surgery when the patient needs opiate for the first time
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03332316 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2017)
  • Opiate consumption [ Time Frame: 48 hours ]
    Total opiate consumption after surgery
  • Pain [ Time Frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours,seventh postoperative day ]
    Numeric rating scale NRS 0-10
  • Mobilisation [ Time Frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours, at 28 hours, 32 hours, at 36 hours, at 40 hours, at 44 hours, at 48 hours ]
    Toe movement every 4 hour during hospitalization
  • Blood glucose [ Time Frame: postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours ]
    Blood glucose every 4 hour during hospitalization
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: November 1, 2017)
  • Quality of life (EQ-5D-3L) -query [ Time Frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively ]
  • McGill -pain query [ Time Frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Official Title  ICMJE Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Brief Summary Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery
Detailed Description

This study is proposed to explore the effect of perineural dexamethasone on the duration of popliteal nerve block for analgesia after ankle surgery.

After ankle or foot arthrodesis patients need a good analgesia. Nevertheless early mobilisation and discharge are important for the healing process after surgery. Peripheral nerve blocks have provided a safe, effective method to control early postoperative pain when symptoms are most severe. Perineural dexamethasone added to local anesthetic prolongs the duration of analgesia of the perineural nerve block.

The perineural use of dexamethasone is still off-label. There is a ongoing discussion of which has better benefits, intravenous or perineural dexamethasone.

There are multiple research where the intravenous and perineural dexamethasone use has compared, but there is still a limited amount of research of low dose perineural dexamethasone versus intravenous dexamethasone.

In this study investigators compare different doses of perineural dexamethasone added to ropivacaine 2 mg/ml 20ml. After arthrodesis under spinal anaesthesia the patients receive popliteal block ropivacaine 2 mg/ml 20 ml and dexamethasone of different doses. Groups 1 to 4 has dexamethasone doses 0, 2mg, 3mg or 4 mg.

After the popliteal nerve block investigators follow postoperative pain, opiate consumption, mobilisation and long term quality of life.

Investigators goal is to find a dexamethasone dose which is as low as possible but at the same time covers the need for a good pain relief and fast recovery postoperatively.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE
  • Postoperative Pain
  • Nerve Block
Intervention  ICMJE
  • Drug: Dexamethasone Sodium Phosphate
    Dexamethasone injection
    Other Name: Oradexon
  • Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
    Ropivacaine injection
  • Drug: Sodium Chloride 9mg/mL
    Sodium Chloride injection
    Other Name: Saline
Study Arms  ICMJE
  • Placebo Comparator: DEXA0
    Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally
    Interventions:
    • Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
    • Drug: Sodium Chloride 9mg/mL
  • Experimental: DEXA1
    Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,2 ml and Sodium Chloride 9mg/mL 0,8 ml perineurally
    Interventions:
    • Drug: Dexamethasone Sodium Phosphate
    • Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
    • Drug: Sodium Chloride 9mg/mL
  • Experimental: DEXA2
    Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,4 ml and Sodium Chloride 9mg/mL 0,6 ml perineurally
    Interventions:
    • Drug: Dexamethasone Sodium Phosphate
    • Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
    • Drug: Sodium Chloride 9mg/mL
  • Experimental: DEXA4
    Ropivacaine Hydrochloride Inj 2 mg/ml 20 ml and Dexamethasone Sodium Phosphate 5mg/ml 0,8 ml and Sodium Chloride 9mg/mL 0,2 ml perineurally
    Interventions:
    • Drug: Dexamethasone Sodium Phosphate
    • Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
    • Drug: Sodium Chloride 9mg/mL
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 1, 2017)
84
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2020
Estimated Primary Completion Date May 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

Adult people under ankle/foot arthrodesis as a curative therapy of ankle arthrosis or situation after ankle injury or malposition

Exclusion Criteria:

Age under 18 years Complicated diabetes mellitus Lack of finnish language skill and/or co-operation Chronic pain Steroid medication in regular use

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 99 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Maija-Liisa Kalliomäki, PhD +358 3 311 69424 maija-liisa.kalliomaki@pshp.fi
Contact: Jenni Kanerva, PhD +358 3 311 67415 jenni.kanerva@pshp.fi
Listed Location Countries  ICMJE Finland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03332316
Other Study ID Numbers  ICMJE R17104M
2017-002185-51 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Tampere University Hospital
Study Sponsor  ICMJE Tampere University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Maija-Liisa Kalliomäki, PhD Tampere University Hospital
PRS Account Tampere University Hospital
Verification Date April 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP