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

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03332316
• Other study ID #: R17104M
• Secondary ID: 2017-002185-51
• Status: Completed
• Phase: Phase 4
• Start date: November 2, 2017
• Est. completion date: November 21, 2023

Study information

• Verified date: November 2023
• Source: Tampere University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: November 21, 2023
• Est. primary completion date: November 21, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Nerve Block
• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Dexamethasone Sodium Phosphate
Dexamethasone injection
• Ropivacaine Hydrochloride Inj 2 mg/ml
Ropivacaine injection
• Sodium Chloride 9mg/mL
Sodium Chloride injection

Locations

Country	Name	City	State
Finland	Tampere University Hospital	Tampere

Sponsors (1)

Lead Sponsor	Collaborator
Tampere University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Quality of life (EQ-5D-3L) -query		Before operation and 6-8 weeks, 6 months, 12 months postoperatively
Other	McGill -pain query		Before operation and 6-8 weeks, 6 months, 12 months postoperatively
Primary	First need of opiate	Time after surgery when the patient needs opiate for the first time	48 hours
Secondary	Opiate consumption	Total opiate consumption after surgery	48 hours
Secondary	Pain	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
Secondary	Mobilisation	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
Secondary	Blood glucose	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