Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery. A Randomized Double-blind, Controlled Study Comparing Bupivacaine-Epinephrine 0.5% Versus Bupivacaine-Epinephrine 0.5% With Dexamethasone

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02526199

Enrollment

Registered

2015-08-18

Start date

2015-08-31

Completion date

2016-07-31

Last updated

2016-09-23

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

Conditions

Postoperative Pain

Keywords

Local anesthetics, Perineural nerve blocks, Perineurial Dexamethasone

Brief summary

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.

Interventions

DRUGBupivacaine

Sciatic nerve block

DRUGEpinephrine

Adjuvant to perinerual block

DRUGDexamethasone

Adjuvant to perinerual block

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Caregiver, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

Measure	Time frame	Description
Painfree period (time until first pain sensation in operated foot)	48 hours	Patients are closely monitored in the PACU until first pain sensation in the operated foot.

Secondary

Measure	Time frame	Description
quality of sleep first night measured on a 3 point scale	hours	Quality of sleep measured on the morning after operation. 0 (good sleep, no interruptions) by pain from operated foot) 1 (sleep, but interruption without pain) 2 (sleep but interrupted by pain from operated foot)
Pain in the operated foot, measured on a numeric rating scale (0-10)	Every 30 minuttes from the patient enters the PACU to the nerve block wears of	Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 \[no pain\] to 10 \[worst possible pain\]
Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot	Every 30 minutes from the patient enters the PACU to the sensations core reach 2	Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side
Total consumption of opioids during the length of stay	48 hours	A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay

Countries

Denmark

Outcome results

None listed

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