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

Primary Purpose

Postoperative Pain, Nerve Block

Status
Unknown status
Phase
Phase 4
Locations
Finland
Study Type
Interventional
Intervention
Dexamethasone Sodium Phosphate
Ropivacaine Hydrochloride Inj 2 mg/ml
Sodium Chloride 9mg/mL
Sponsored by
Tampere University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Postoperative Pain

Eligibility Criteria

18 Years - 99 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tampere University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Placebo Comparator

Experimental

Experimental

Experimental

Arm Label

DEXA0

DEXA1

DEXA2

DEXA4

Arm Description

Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally

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

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

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

Outcomes

Primary Outcome Measures

First need of opiate
Time after surgery when the patient needs opiate for the first time

Secondary Outcome Measures

Opiate consumption
Total opiate consumption after surgery
Pain
Numeric rating scale NRS 0-10
Mobilisation
Toe movement every 4 hour during hospitalization
Blood glucose
Blood glucose every 4 hour during hospitalization

Full Information

First Posted
October 26, 2017
Last Updated
October 4, 2021
Sponsor
Tampere University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT03332316
Brief Title
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Official Title
Effect of Perineural Dexamethasone on the Duration of Popliteal Nerve Block for Anesthesia After Ankle Surgery
Study Type
Interventional

2. Study Status

Record Verification Date
October 2021
Overall Recruitment Status
Unknown status
Study Start Date
November 2, 2017 (Actual)
Primary Completion Date
December 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tampere University Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Postoperative Pain, Nerve Block

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
DEXA0
Arm Type
Placebo Comparator
Arm Description
Ropivacaine Hydrochloride Inj 2mg/ml 20 ml and Sodium Chloride 9mg/mL 1 ml perineurally
Arm Title
DEXA1
Arm Type
Experimental
Arm Description
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
Arm Title
DEXA2
Arm Type
Experimental
Arm Description
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
Arm Title
DEXA4
Arm Type
Experimental
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
Dexamethasone Sodium Phosphate
Other Intervention Name(s)
Oradexon
Intervention Description
Dexamethasone injection
Intervention Type
Drug
Intervention Name(s)
Ropivacaine Hydrochloride Inj 2 mg/ml
Intervention Description
Ropivacaine injection
Intervention Type
Drug
Intervention Name(s)
Sodium Chloride 9mg/mL
Other Intervention Name(s)
Saline
Intervention Description
Sodium Chloride injection
Primary Outcome Measure Information:
Title
First need of opiate
Description
Time after surgery when the patient needs opiate for the first time
Time Frame
48 hours
Secondary Outcome Measure Information:
Title
Opiate consumption
Description
Total opiate consumption after surgery
Time Frame
48 hours
Title
Pain
Description
Numeric rating scale NRS 0-10
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
Title
Mobilisation
Description
Toe movement every 4 hour during hospitalization
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
Title
Blood glucose
Description
Blood glucose every 4 hour during hospitalization
Time Frame
postoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hours
Other Pre-specified Outcome Measures:
Title
Quality of life (EQ-5D-3L) -query
Time Frame
Before operation and 6-8 weeks, 6 months, 12 months postoperatively
Title
McGill -pain query
Time Frame
Before operation and 6-8 weeks, 6 months, 12 months postoperatively

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maija-Liisa Kalliomäki, PhD
Organizational Affiliation
Tampere University Hospital
Official's Role
Study Director
Facility Information:
Facility Name
Tampere University Hospital
City
Tampere
ZIP/Postal Code
33521
Country
Finland

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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