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

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.

Status
UNKNOWN
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02282956
Acronym
Hallux
Enrollment
60
Registered
2014-11-05
Start date
2014-10-31
Completion date
2017-03-31
Last updated
2016-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hallux Valgus

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.

Interventions

Ropivacaine injection

PROCEDUREposterior tibial nerve block

ultrasound guided posterior tibal nerve block

DRUGmorphine and droperidol

i.v PCA

Sponsors

Dr.med. Sabine Schoenfeld
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
morphine requirement24 hoursa 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

MeasureTime frameDescription
sleeping quality24 hourssleeping quality in the first postoperative night, questionaire

Countries

Switzerland

Contacts

Primary ContactSabine Schoenfeld, MD
sabine.schoenfeld@srrws.ch0041817725662
Backup ContactVolha Berning, MD
volha.berning@srrws.ch0041817725654

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026