Comparison of dexamethasone route of administration on ankle block duration and analgesia for foot and ankle surgery

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12611001166965

Enrollment

Registered

2011-11-08

Start date

2012-01-02

Completion date

Unknown

Last updated

2020-01-13

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

Conditions

None listed

Brief summary

Post operative pain following ankle and foot surgery is troublesome. It is common practice for regional anaesthetic blockade to be used to prolong post operative pain relief for about 14 hours. Dexamethasone has been shown to prolong regional blockade in the upper limb, but this has not been investigated in the lower limb. The optimal route of administration for dexamethasone has not been investigated and it is unknown whether there is advantage to administering dexamethasone intravenously, or mixed with the block. We aim to investigate whether dexamethasone can prolong regional anaesthesia in the lower limb and determine if there are differences in effect when administered intravenously compared with when it is added to the block.

Interventions

Patients undergoing elective ankle or foot surgery will receive an ultrasound guided ankle/foot block and be randomly allocated to one of three groups: Arm 1 The intravenous dexamethasone group will receive 8 mg (2 ml) dexamethasone intravenously and 2 ml saline added to the ropivacaine ankle block. Arm 2 The ankle block dexamethasone group will receive 8 mg (2 ml) dexamethasone added into the ropivacaine ankle block and 2 ml saline intravenously.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Treatment

Masking

Blinded (masking used)

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

Elective patients having metatarsal osteotomy for foot surgery American Society of Anaesthesiologists score 1-3

Exclusion criteria

American Society of Anaesthesiologists score of 4 or greater Contraindication to ankle block (patient refusal, coagulopathy, sepsis, local infection, allergy to ropivacaine) Contraindication to dexamethasone (eg. known hypersensitivity, poorly controlled diabetes mellitus) Pre-existing sensory deficit around the site of surgical intervention (eg. peripheral neuropathy, stroke) Systemic glucocorticoid treatment of >10mg prednisolone (or equivalent) for two weeks or more within three months of surgery Chronic opioid use define as >30mg oral morphine per day or equivalent (Fentanyl patch 12mcg/hr; buprenorphine 20mcg/hr; oxycodone >20mg/day) Contraindication to non-steroidal anti-inflammatory drugs (NSAIDs) (eg. known hypersensitivity, active peptic ulcer disease, renal impairment, pregnancy) Previous enrolment in this study Inability to understand english

Outcome results