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

November 22, 2023 updated by: Tampere University Hospital
Effect of perineural dexamethasone on the duration of popliteal nerve block after ankle/foot surgery

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Interventional

Enrollment (Actual)

84

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Tampere, Finland, 33521
        • Tampere University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 97 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / 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 Names:
  • 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: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
  • Saline
Drug: Dexamethasone Sodium Phosphate
Dexamethasone injection
Other Names:
  • Oradexon
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: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
  • Saline
Drug: Dexamethasone Sodium Phosphate
Dexamethasone injection
Other Names:
  • Oradexon
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: Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
Drug: Sodium Chloride 9mg/mL
Sodium Chloride injection
Other Names:
  • Saline
Drug: Dexamethasone Sodium Phosphate
Dexamethasone injection
Other Names:
  • Oradexon

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
First need of opiate
Time Frame: 48 hours
Time after surgery when the patient needs opiate for the first time
48 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Opiate consumption
Time Frame: 48 hours
Total opiate consumption after surgery
48 hours
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
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
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
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
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
postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours

Other Outcome Measures

Outcome Measure
Time Frame
Quality of life (EQ-5D-3L) -query
Time Frame: Before operation and 6-8 weeks, 6 months, 12 months postoperatively
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
Before operation and 6-8 weeks, 6 months, 12 months postoperatively

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tampere University Hospital

Investigators

  • Study Director: Maija-Liisa Kalliomäki, PhD, Tampere University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 2, 2017

Primary Completion (Actual)

November 21, 2023

Study Completion (Actual)

November 21, 2023

Study Registration Dates

First Submitted

October 26, 2017

First Submitted That Met QC Criteria

November 1, 2017

First Posted (Actual)

November 6, 2017

Study Record Updates

Last Update Posted (Actual)

November 28, 2023

Last Update Submitted That Met QC Criteria

November 22, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R17104M
  • 2017-002185-51 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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