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

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

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03332316
Enrollment
84
Registered
2017-11-06
Start date
2017-11-02
Completion date
2023-11-21
Last updated
2023-11-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Postoperative Pain, Nerve Block

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.

Interventions

DRUGDexamethasone Sodium Phosphate

Dexamethasone injection

DRUGRopivacaine Hydrochloride Inj 2 mg/ml

Ropivacaine injection

Sodium Chloride injection

Sponsors

Tampere University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
First need of opiate48 hoursTime after surgery when the patient needs opiate for the first time

Secondary

MeasureTime frameDescription
Opiate consumption48 hoursTotal opiate consumption after surgery
Painpostoperatively: 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 dayNumeric rating scale NRS 0-10
Mobilisationpostoperatively: 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 hoursToe movement every 4 hour during hospitalization
Blood glucosepostoperatively: at 4 hours, at 8 hours,at 12 hours, at 16 hours, at 20 hours, at 24 hoursBlood glucose every 4 hour during hospitalization

Other

MeasureTime frame
Quality of life (EQ-5D-3L) -queryBefore operation and 6-8 weeks, 6 months, 12 months postoperatively
McGill -pain queryBefore operation and 6-8 weeks, 6 months, 12 months postoperatively

Countries

Finland

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026