Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery (Hallux)
Primary Purpose
Hallux Valgus
Status
Unknown status
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Ropivacaine 0,75%
posterior tibial nerve block
morphine and droperidol
Sponsored by
About this trial
This is an interventional treatment trial for Hallux Valgus
Eligibility Criteria
Inclusion Criteria:
- Age over 18 years
- Elective Hallux valgus surgery ("Magerl" operation technique)
Exclusion Criteria:
- 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
Sites / Locations
- Spital GrabsRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Other
Arm Label
study group
controll Group
Arm Description
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.
After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.
Outcomes
Primary Outcome Measures
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).
Secondary Outcome Measures
sleeping quality
sleeping quality in the first postoperative night, questionaire
Full Information
NCT ID
NCT02282956
First Posted
October 27, 2014
Last Updated
April 29, 2016
Sponsor
Dr.med. Sabine Schoenfeld
1. Study Identification
Unique Protocol Identification Number
NCT02282956
Brief Title
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
Acronym
Hallux
Official Title
Monocentric, Non-blinded, Prospective Randomized Parallel Group Phase IV Clinical Study to Evaluate the Efficacy of Ultrasound Guided Single Shot Block of Nervus Tibialis Posterior for Postoperative Pain Relief After Hallux Valgus Surgery.
Study Type
Interventional
2. Study Status
Record Verification Date
April 2016
Overall Recruitment Status
Unknown status
Study Start Date
October 2014 (undefined)
Primary Completion Date
February 2017 (Anticipated)
Study Completion Date
March 2017 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dr.med. Sabine Schoenfeld
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
Detailed Description
The overall purpose is to evaluate the effectiveness of tibial nerve block for postoperative pain relief after hallux surgery. The primary objective is to assess the morphine requirement in the first 24 hours after surgery. Secondary objectives are maximum pain scores and sleeping quality in the postoperative period. Patient's satisfaction with the pain therapy and approximately nerve block duration will be asked in the final interview.
Primary study endpoint is 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).
Secondary endpoints are sleeping quality and maximum pain scores (maximum VAS) measured by means of postoperative questionnaire.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hallux Valgus
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
study group
Arm Type
Experimental
Arm Description
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.
Arm Title
controll Group
Arm Type
Other
Arm Description
After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.
Intervention Type
Drug
Intervention Name(s)
Ropivacaine 0,75%
Other Intervention Name(s)
Naropin 0,75%
Intervention Description
Ropivacaine injection
Intervention Type
Procedure
Intervention Name(s)
posterior tibial nerve block
Intervention Description
ultrasound guided posterior tibal nerve block
Intervention Type
Drug
Intervention Name(s)
morphine and droperidol
Other Intervention Name(s)
DHBP
Intervention Description
i.v PCA
Primary Outcome Measure Information:
Title
morphine requirement
Description
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).
Time Frame
24 hours
Secondary Outcome Measure Information:
Title
sleeping quality
Description
sleeping quality in the first postoperative night, questionaire
Time Frame
24 hours
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age over 18 years
Elective Hallux valgus surgery ("Magerl" operation technique)
Exclusion Criteria:
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sabine Schoenfeld, MD
Phone
0041817725662
Email
sabine.schoenfeld@srrws.ch
First Name & Middle Initial & Last Name or Official Title & Degree
Volha Berning, MD
Phone
0041817725654
Email
volha.berning@srrws.ch
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabine Schoenfeld, MD
Organizational Affiliation
9472 Grabs, Spitalstrasse 44, switzerland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Spital Grabs
City
Grabs
ZIP/Postal Code
9472
Country
Switzerland
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sabine Schoenfeld, MD
Phone
0041817725662
Email
sabine.schoenfeld@srrws.ch
First Name & Middle Initial & Last Name & Degree
Volha Berning, MD
Phone
0041817725654
Email
volha.berning@srrws.ch
12. IPD Sharing Statement
Citations:
PubMed Identifier
17400530
Citation
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.
Results Reference
background
Links:
URL
http://www.ncbi.nlm.nih.gov/pubmed
Description
pubmed
Learn more about this trial
Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
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