NCT02282956

Brief Summary

Hallux surgery is known to be extremely painful. Standard pain therapy is treatment with NSAID and opioid painkillers. Patients are frequently not-satisfied with this. Some institutions use a nerve block (single shot or catheter technic) of the ischiadic nerve. But this procedure is invasive, has a potential risk of nerve lesion, and is not accepted by all surgeons. A single shot nerve block of the posterior tibial nerve is less invasive and could be superior compared to standard pain treatment. A great variability of nerve supply of the foot is well described. There are some hints that the posterior tibial nerve supplies the first metatarsal bone and the first metatarsal joint. A nerve block could reduce postoperative pain in hallux surgery. To assess the effectiveness of this investigated measure, the requested morphine dose of a PCA pump will be used to verify the effectiveness of the tibial nerve block.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for phase_4

Timeline
Completed

Started Oct 2014

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
26 days until next milestone

First Submitted

Initial submission to the registry

October 27, 2014

Completed
9 days until next milestone

First Posted

Study publicly available on registry

November 5, 2014

Completed
2.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2017

Completed
28 days until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2017

Completed
Last Updated

May 2, 2016

Status Verified

April 1, 2016

Enrollment Period

2.3 years

First QC Date

October 27, 2014

Last Update Submit

April 29, 2016

Conditions

Hallux Valgus

Outcome Measures

Primary Outcomes (1)

  • morphine requirement

    a 50% reduction of morphine requirement with a 60% standard deviation within 24 hours after surgery. Power is 80%, the level of significance is set at 5% (p \< 0,05).

    24 hours

Secondary Outcomes (1)

  • sleeping quality

    24 hours

Study Arms (2)

study group

EXPERIMENTAL

single shot, posterior tibial nerve block with 5 ml of Ropivacaine 0,75% before surgery postoperative PCA pump with morphine and droperidol (DHBP®) for the next 24 hours.

Drug: Ropivacaine 0,75%Procedure: posterior tibial nerve blockDrug: morphine and droperidol

controll Group

OTHER

After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.

Drug: morphine and droperidol

Interventions

Ropivacaine 0,75%DRUG

Ropivacaine injection

Also known as: Naropin 0,75%
study group
posterior tibial nerve blockPROCEDURE

ultrasound guided posterior tibal nerve block

study group
morphine and droperidolDRUG

i.v PCA

Also known as: DHBP
controll Groupstudy group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age over 18 years
  • Elective Hallux valgus surgery ("Magerl" operation technique)

You may not qualify if:

  • Patient refusal, pregnancy
  • Regular medication with opioids
  • Drug abuse
  • Contraindication for regional anesthesia
  • Known allergy against one of the study drugs
  • Polyneuropathia, or any other neurodegenerative disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Spital Grabs

Grabs, 9472, Switzerland

RECRUITING

Related Publications (1)

  • Unlu RE, Orbay H, Kerem M, Esmer AF, Tuccar E, Sensoz O. Innervation of three weight-bearing areas of the foot: an anatomic study and clinical implications. J Plast Reconstr Aesthet Surg. 2008;61(5):557-61. doi: 10.1016/j.bjps.2007.02.007. Epub 2007 Apr 2.

    PMID: 17400530BACKGROUND

Related Links

MeSH Terms

Conditions

Hallux Valgus

Interventions

MorphineDroperidol

Condition Hierarchy (Ancestors)

Foot DeformitiesMusculoskeletal Diseases

Intervention Hierarchy (Ancestors)

Morphine DerivativesMorphinansOpiate AlkaloidsAlkaloidsHeterocyclic CompoundsHeterocyclic Compounds, Bridged-RingHeterocyclic Compounds, 4 or More RingsHeterocyclic Compounds, Fused-RingPhenanthrenesPolycyclic Aromatic HydrocarbonsPolycyclic CompoundsButyrophenonesKetonesOrganic ChemicalsBenzimidazolesHeterocyclic Compounds, 2-Ring

Study Officials

  • Sabine Schoenfeld, MD

    9472 Grabs, Spitalstrasse 44, switzerland

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Sabine Schoenfeld, MD

CONTACT

0041817725662sabine.schoenfeld@srrws.ch

Volha Berning, MD

CONTACT

0041817725654volha.berning@srrws.ch

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior consultant for anesthesia

Study Record Dates

First Submitted

October 27, 2014

First Posted

November 5, 2014

Study Start

October 1, 2014

Primary Completion

February 1, 2017

Study Completion

March 1, 2017

Last Updated

May 2, 2016

Record last verified: 2016-04

Locations

CH(1)