Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery

Hallux Valgus Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02282956
• Other study ID #: EKSG 13/126
• Status: Recruiting
• Phase: Phase 4
• First received: October 27, 2014
• Last updated: April 29, 2016
• Start date: October 2014
• Est. completion date: March 2017

Study information

• Verified date: April 2016
• Source: Spitalregion Rheintal, Werdenberg, Sarganserland
• Contact: Sabine Schoenfeld, MD
• Phone: 0041817725662
• Email: sabine.schoenfeld[@]srrws.ch
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: March 2017
• Est. primary completion date: February 2017
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hallux Valgus
• Pain, Postoperative

Intervention

Drug:
• Ropivacaine 0,75%
Ropivacaine injection

Procedure:
• posterior tibial nerve block
ultrasound guided posterior tibal nerve block

Drug:
• morphine and droperidol
i.v PCA

Locations

Country	Name	City	State
Switzerland	Spital Grabs	Grabs

Sponsors (1)

Lead Sponsor	Collaborator
Dr.med. Sabine Schoenfeld

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Unlü RE, Orbay H, Kerem M, Esmer AF, Tüccar E, Sensöz 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. Epub 2007 Apr 2. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	sleeping quality	sleeping quality in the first postoperative night, questionaire	24 hours	No

External Links

•   pubmed