Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Phase 4

Completed

• Conditions: Postoperative Pain
• Interventions: Drug: Bupivacaine; Drug: Epinephrine; Drug: Dexamethasone

• Registration Number: NCT02526199
• Lead Sponsor: Rasmus Wulff Hauritz

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08
• Study First Submitted: 2015-08-11
• Study First Submitted QC: 2015-08-17
• Study First Posted: 2015-08-18
• Primary Completion: 2016-07
• Study Completion: 2016-07
• Status Verified: 2016-09
• Last Update Submitted: 2016-09-22
• Last Update Posted: 2016-09-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 56

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

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

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
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)

Trial Locations

Locations (1)

Department of Anesthesia, Aarhus University Hospital; 🇩🇰 Aarhus, Region Midt, Denmark