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Trial record 65 of 399 for:    sodium phosphate

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

Brief Summary:
Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

Condition or disease Intervention/treatment Phase
Postoperative Pain Nerve Block Drug: Dexamethasone Sodium Phosphate Drug: Ropivacaine Hydrochloride Inj 2 mg/ml Drug: Sodium Chloride 9mg/mL Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Actual Study Start Date : November 2, 2017
Estimated Primary Completion Date : May 2020
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Placebo Comparator: DEXA0
Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally
Drug: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection

Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Name: Saline

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
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

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
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

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
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




Primary Outcome Measures :
  1. First need of opiate [ Time Frame: 48 hours ]
    Time after surgery when the patient needs opiate for the first time


Secondary Outcome Measures :
  1. Opiate consumption [ Time Frame: 48 hours ]
    Total opiate consumption after surgery

  2. 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

  3. 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

  4. 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


Other Outcome Measures:
  1. Quality of life (EQ-5D-3L) -query [ Time Frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively ]
  2. McGill -pain query [ Time Frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively ]


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Ages Eligible for Study:   18 Years to 99 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03332316


Contacts
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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

Locations
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Finland
Tampere University Hospital Recruiting
Tampere, Finland, 33521
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   
Principal Investigator: Suvi Kastikainen, PhD         
Principal Investigator: Jenni Kanerva, PhD         
Sponsors and Collaborators
Tampere University Hospital
Investigators
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Study Director: Maija-Liisa Kalliomäki, PhD Tampere University Hospital

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Responsible Party: Tampere University Hospital
ClinicalTrials.gov Identifier: NCT03332316     History of Changes
Other Study ID Numbers: R17104M
2017-002185-51 ( EudraCT Number )
First Posted: November 6, 2017    Key Record Dates
Last Update Posted: April 24, 2019
Last Verified: April 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Dexamethasone 21-phosphate
Pain, Postoperative
Postoperative Complications
Pathologic Processes
Pain
Neurologic Manifestations
Signs and Symptoms
Dexamethasone
Dexamethasone acetate
Ropivacaine
BB 1101
Anti-Inflammatory Agents
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents