High Ankle Block in Ankle Fractures

NCT ID: NCT04292691

Last Updated: 2020-03-03

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-04-01
• Study Completion Date: 2021-08-01

Brief Summary

The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures.

Included will be all adult patients (>18a) treated surgically at our department. The standard peri-operative procedure at our clinic will no be altered but the additional high ankle block. The intraoperative opioid requirement, the Visual Analogue Scale for Pain (VAS) and the postoperative opioid requirement will be assessed and compared between the two groups

Detailed Description

Ankle fractures were among the most common injuries of the lower extremity. Peri-operative, multimodal pain therapy is of great importance in the surgical treatment of those injuries. Whereas simple (uni- and bimalleolar) ankle fractures are covered peri-operatively by oral pain medication and Piritramid-PCA (PCA=Patient-controlled analgesia), complex, trimalleolar fractures usually receive additional regional pain catheters (femoralis blockade and ischiadicus blockade).

Regional pain catheters have the major downside of motor paresis and are therefore critically discussed. Various studies have explored new techniques for perioperative pain therapy. An established procedure in midfoot and forefoot surgery is the foot block. It can be inserted at different heights around the ankle joint. However, the effectiveness of the high foot block has not yet been investigated for ankle fractures. The aim of the herein presented double-blinded is to compare the effectiveness of the high foot block against placebo infiltration in simple, uni- and bimalleolar ankle fractures.

All patients who are operated on in our department due to a uni- or bimalleolar ankle fracture, who are over 18 years of age and have no serious pre-existing conditions or contraindications to local anaesthesia (LA) are eligible for inclusion.

The perioperative procedure does not change to the current treatment standard at the University Hospital Munich - Ludwig Maximilians University (LMU) except for randomization for high foot block or placebo. Both the anesthesia and the postoperative pain therapy correspond to the current treatment standard and are the same for both groups. The intraoperative opioid requirement, the VAS and the postoperative opioid requirement will be assessed.

The data is collected using the RedCap database (#19-177), which has already been reviewed by the ethics committee. The evaluation will be performed using SPSS 25.0 (IBM).

Conditions

Ankle Fractures; Anesthesia, Local

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Ropivacaine

A cumulative amount of approx. 40ml ropivacaine 0.5% (≙400mg (2x200mg) ropivacaine) is applied immediately before surgery. They are applied in a ring wall 10 cm cranially of the tip of the medial and lateral malleolus (N. peroneus superficialis (N. cutaneus dorsalis medius et intermedius, N. saphenus, N. suralis), as well as sonographically controlled (N. peroneus profundus and N. suralis)

Group Type: EXPERIMENTAL

40ml of Ropivacaine 0.5% Injectable Solution

Intervention Type: DRUG

already outlined in the arm/group description

Ringer's Lactate

Analog to the Experimental Arm, but the same amount of Ringer (40ml) will be plicated instead Ropivacaine

Group Type: PLACEBO_COMPARATOR

40ml of Ringer's Lactate

Intervention Type: DRUG

already outlined in the arm/group description

Interventions

40ml of Ropivacaine 0.5% Injectable Solution

already outlined in the arm/group description

Intervention Type: DRUG

40ml of Ringer's Lactate

already outlined in the arm/group description

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Age >17 years and <71 years
• Glomerular filtration rate (GFR) > 60
• American Society of Anaesthesiologists physical status classification system (ASA) < 4
• Independently mobile without aids before an accident
• Informed consent
• Uni- or bimalleolar (medial and lateral malleolus) ankle fractures requiring surgery

Exclusion Criteria

• Age <18 years; >70 years
• GFR < 60
• ASA > 3
• Trimalleolar fractures or fractures necessitating open reduction and internal fixation (ORIF) of the posterior malleolus
• Not able to walk without aids (stick, rollator, etc.)
• Allergy to local anesthetics or drugs of the postOP pain regime
• Peripheral polyneuropathy
• Peripheral artery disease (PAD) grade IV°
• Dementia
• Depression, anxiety disorders or sleep disorders 18
• Pregnancy
• Denial of study participation

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ludwig-Maximilians - University of Munich

OTHER

Sponsor Role: lead

Responsible Party

Sebastian. F. Baumbach

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sebastian F Baumbach, MD

Role: PRINCIPAL_INVESTIGATOR

Ludwig-Maximilians - University of Munich

Central Contacts

Sebastian F Baumbach, MD

Role: CONTACT

sebastian.baumbach@med.uni-muenchen.de

0049894400519474

Hans Polzer, MD

Role: CONTACT

hans.polzer@med.uni-muenchen.de

004989440052511

Other Identifiers

2020-1

Identifier Type: -

Identifier Source: org_study_id