Protracted Mixture of Local Anesthetics for Major Foot and Ankle Surgery

Postoperative Pain Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02526199
• Other study ID #: 2014-005383-14
• Status: Completed
• Phase: Phase 4
• First received: August 11, 2015
• Last updated: September 22, 2016
• Start date: August 2015
• Est. completion date: July 2016

Study information

• Verified date: September 2016
• Source: Kolding Sygehus
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines Authority
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: July 2016
• Est. primary completion date: July 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain, Postoperative
• Postoperative Pain

Intervention

Drug:
• Bupivacaine
Sciatic nerve block
• Epinephrine
Adjuvant to perinerual block
• Dexamethasone
Adjuvant to perinerual block

Locations

Country	Name	City	State
Denmark	Department of Anesthesia, Aarhus University Hospital	Aarhus	Region Midt

Sponsors (2)

Lead Sponsor	Collaborator
Rasmus Wulff Hauritz	Aarhus University Hospital

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Painfree period (time until first pain sensation in operated foot)	Patients are closely monitored in the PACU until first pain sensation in the operated foot.	48 hours	No
Secondary	Pain in the operated foot, measured on a numeric rating scale (0-10)	Pain score at rest, with the operated foot elevated on a pillow, ranging from 0 [no pain] to 10 [worst possible pain]	Every 30 minuttes from the patient enters the PACU to the nerve block wears of	No
Secondary	Sensibility score, measured with a hided tactile pinprick-sensation under the 3.rd toe on the operated foot	Sensitivy score measured on a 3 point scale 0 (no sensation) (impared sensation) 2 (full or normal sensation) compared to non-operated side	Every 30 minutes from the patient enters the PACU to the sensations core reach 2	No
Secondary	Total consumption of opioids during the length of stay	A cummulative calculation of equipotente doses of oral milligrams of morphin during the length of stay	48 hours	No
Secondary	quality of sleep first night measured on a 3 point scale	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)	hours	No