Clinical trial NCT02282956: Ultrasound Guided Single Shot Block of Posterior Tibial Nerve for Postoperative Pain Relief After Hallux Valgus Surgery
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
Overall status: UNKNOWN
Phase: PHASE4
Conditions: Hallux Valgus
Lead sponsor: Spitalregion Rheintal, Werdenberg, Sarganserland
Sponsor class: OTHER
First posted: 2014-11-05
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: morphine requirement
timeFrame: 24 hours
Secondary outcomes:
measure: sleeping quality
timeFrame: 24 hours
Other outcomes:
Locations:
city: Grabs
country: Switzerland
facility: Spital Grabs
Study officials:
affiliation: 9472 Grabs, Spitalstrasse 44, switzerland
name: Sabine Schoenfeld, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.