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

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.

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.

Study Overview

• Status: Unknown
• Conditions: Hallux Valgus
• Intervention / Treatment: Drug: Ropivacaine 0,75%; Procedure: posterior tibial nerve block; Drug: morphine and droperidol

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.

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Phase 4

Contacts and Locations

Study Locations

• Switzerland
  • Grabs, Switzerland, 9472
    • Recruiting
    • Spital Grabs
    • Contact: Sabine Schoenfeld, MD; Phone Number: 0041817725662; Email: sabine.schoenfeld@srrws.ch
    • Contact: Volha Berning, MD; Phone Number: 0041817725654; Email: volha.berning@srrws.ch

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	Drug: Ropivacaine 0,75%; Ropivacaine injection; Other Names: Naropin 0,75%; Procedure: posterior tibial nerve block; ultrasound guided posterior tibal nerve block; Drug: morphine and droperidol; i.v PCA; Other Names: DHBP
Other: controll Group; After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.	Drug: morphine and droperidol; i.v PCA; Other Names: DHBP

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
sleeping quality	sleeping quality in the first postoperative night, questionaire	24 hours

Collaborators and Investigators

• Sponsor: Dr.med. Sabine Schoenfeld
• Investigators: Principal Investigator: Sabine Schoenfeld, MD, 9472 Grabs, Spitalstrasse 44, switzerland

Publications and helpful links

General Publications

• 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.

Helpful Links

• Pubmed

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Anticipated): February 1, 2017
• Study Completion (Anticipated): March 1, 2017

Study Registration Dates

• First Submitted: October 27, 2014
• First Submitted That Met QC Criteria: November 4, 2014
• First Posted (Estimate): November 5, 2014

Study Record Updates

• Last Update Posted (Estimate): May 2, 2016
• Last Update Submitted That Met QC Criteria: April 29, 2016
• Last Verified: April 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Postoperative Complications; Pain; Neurologic Manifestations; Musculoskeletal Diseases; Foot Deformities; Foot Deformities, Acquired; Pain, Postoperative; Hallux Valgus; Bunion; Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Central Nervous System Depressants; Autonomic Agents; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Anesthetics; Antiemetics; Gastrointestinal Agents; Analgesics, Opioid; Narcotics; Antipsychotic Agents; Tranquilizing Agents; Psychotropic Drugs; Dopamine Agents; Dopamine D2 Receptor Antagonists; Dopamine Antagonists; Adjuvants, Anesthesia; Anesthetics, Local; Ropivacaine; Morphine; Droperidol
• Other Study ID Numbers: EKSG 13/126