Long-acting local anesthetic for the treatment of severe pain after major foot and ankle surgery

Protracted mixture of local anaesthetics for major foot and ankle surgery. A randomized double-blind, controlled study comparing Bupivacaine-epinephrine 0.5% and Bupivacaine-epinepherine 0.5% plus dexamethasone - PROMIX

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2014-005383-14-DK

Enrollment

Unknown

Registered

2015-02-09

Start date

2015-04-08

Completion date

Unknown

Last updated

2016-06-13

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

Conditions

The postoperative period after major foot and ankle surgery MedDRA version: 17.1 Level: LLT Classification code 10038286 Term: Regional nerve block System Organ Class: 100000004865

Interventions

Trade Name: Marcain-adrenalin Product Name: Marcain-adrenalin Pharmaceutical Form: Concentrate for solution for injection INN or Proposed INN: Bupivacaine Other descriptive name: BUPIVACAINE HYDROCHLO

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Age = 18 years - Scheduled amputation of the whole foot, parts of the foot or shin with indication for postoperative pain management the form of poplitealt sciatic nerve blockade - Oral and written informed consent to participate in the study after having understood the contents of the protocol and limitations fully Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 28 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 28

Exclusion criteria

Exclusion criteria: Patients meeting one or more of the following exclusion criteria will not be included in the study: - Patients who can not cooperate with the investigation - Patients who do not speak and understand English or Danish - Allergy to drugs used in the study

Design outcomes

Primary

Measure	Time frame
Main Objective: The purpose of the study is to demonstrate a clinically significant difference in the duration of sensory blockade of the sciatic nerve with Bupivacaine-adrenaline plus adjuvant (Dexamethasone) versus blockade with bupivacaine-adrenaline without adjuvant for patients who undergo amputations below knee level.;Secondary Objective: Duration of sensory blockade after sciatic nerve block Sleep quality first night after surgery Cumulated doses of morphine ;Primary end point(s): Primary: Time to breakthrough pain in sciatic nerve area ;Timepoint(s) of evaluation of this end point: 24 hours postoperatively	—

Measure

Time frame

Main Objective: The purpose of the study is to demonstrate a clinically significant difference in the duration of sensory blockade of the sciatic nerve with Bupivacaine-adrenaline plus adjuvant (Dexamethasone) versus blockade with bupivacaine-adrenaline without adjuvant for patients who undergo amputations below knee level.;Secondary Objective: Duration of sensory blockade after sciatic nerve block Sleep quality first night after surgery Cumulated doses of morphine ;Primary end point(s): Primary: Time to breakthrough pain in sciatic nerve area ;Timepoint(s) of evaluation of this end point: 24 hours postoperatively

—

Secondary

Measure	Time frame
Secondary end point(s): Pain (NRS 0-10) for the time 10,12,14,16,18,20,22 and 24 t. Postop. Sensibility (0-1-2) to the time 10,12,14,16,18,20,22 and 24 t. Postop. Opioid use the first 24 hours post-operatively (mg morphine-PCA) Sleep Quality (0-1-2) (no interruptions, awake but no pain, awake with pain;Timepoint(s) of evaluation of this end point: 24 hours postoperatively	—

Countries

Denmark

Contacts

Public ContactDepartment of Aneasthesia

Kolding Hospital, Department of Aneasthesia

rasmus.wulff.hauritz@rsyd.dk4540883486

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026