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

Overview

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.

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: February 2017

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

  • Drug: Ropivacaine 0,75%
    • Ropivacaine injection
  • Procedure: posterior tibial nerve block
    • ultrasound guided posterior tibal nerve block
  • Drug: morphine and droperidol
    • i.v PCA

Arms, Groups and Cohorts

  • Experimental: study group
    • 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.
  • Other: controll Group
    • After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.

Clinical Trial Outcome Measures

Primary Measures

  • morphine requirement
    • Time Frame: 24 hours
    • 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 Measures

  • sleeping quality
    • Time Frame: 24 hours
    • sleeping quality in the first postoperative night, questionaire

Participating in This Clinical Trial

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

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Dr.med. Sabine Schoenfeld
  • Provider of Information About this Clinical Study
    • Sponsor-Investigator: Dr.med. Sabine Schoenfeld, senior consultant for anesthesia – Spitalregion Rheintal, Werdenberg, Sarganserland
  • Overall Official(s)
    • Sabine Schoenfeld, MD, Principal Investigator, 9472 Grabs, Spitalstrasse 44, switzerland
  • Overall Contact(s)
    • Sabine Schoenfeld, MD, 0041817725662, sabine.schoenfeld@srrws.ch

References

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.

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