Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Rasmus Wulff Hauritz

Status and phase: Completed; Phase 4

Conditions: Postoperative Pain

Treatments: Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone

Study type: Interventional

Funder types: Other

Identifiers

NCT02526199

2014-005383-14

Details and patient eligibility

About

To extend the duration of peripheral nerve blockade after major foot and ankle surgery the investigators randomize the postoperative treatment with either perineurial sciatic nerve blocks with 0.5% Bupivacaine-Epinephrine with or without Dexamethasone.

Enrollment: 56 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• age > 17
• scheduled major foot and ankle surgery
• written informed consent
• fertile women in anti conceptive treatment
• fertile women not in anti conceptive treatment, but with negative urin-HCG on day of surgery

Exclusion criteria

• patients not able to understand or cooperate
• allergies to medicines involved
• daily buse of steroids
• daily use of opioids

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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56 participants in 2 patient groups

Group BA

Active Comparator group

Description:

Bupivacaine + Adrenaline Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml

Treatment:

Drug: Epinephrine

Drug: Bupivacaine

Group BAD

Experimental group

Description:

Bupivacine + Adrenaline + Dexamethasone Sciatic nerve block with Bupivacaine 0.5% + Epinephrine 5 microg/ml PLUS Dexamethsone 8 mg

Treatment:

Drug: Dexamethasone

Drug: Epinephrine

Drug: Bupivacaine