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

NCT ID: NCT02282956

Last Updated: 2016-05-02

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE4
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-10-31
• Study Completion Date: 2017-03-31

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.

Conditions

Hallux Valgus

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Ropivacaine 0,75%

Intervention Type: DRUG

Ropivacaine injection

posterior tibial nerve block

Intervention Type: PROCEDURE

ultrasound guided posterior tibal nerve block

morphine and droperidol

Intervention Type: DRUG

i.v PCA

controll Group

After surgery: standard analgesic treatment by PCA (patient controlled analgesia) pumps with morphine and Droperidol (DHBP®) for the next 24 hours.

Group Type: OTHER

morphine and droperidol

Intervention Type: DRUG

i.v PCA

Interventions

Ropivacaine 0,75%

Ropivacaine injection

Intervention Type: DRUG

posterior tibial nerve block

ultrasound guided posterior tibal nerve block

Intervention Type: PROCEDURE

morphine and droperidol

i.v PCA

Intervention Type: DRUG

Other Intervention Names

Naropin 0,75%; DHBP

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Dr.med. Sabine Schoenfeld

OTHER

Sponsor Role: lead

Responsible Party

Dr.med. Sabine Schoenfeld

senior consultant for anesthesia

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Sabine Schoenfeld, MD

Role: PRINCIPAL_INVESTIGATOR

9472 Grabs, Spitalstrasse 44, switzerland

Locations

Spital Grabs

Grabs, , Switzerland

Site Status: RECRUITING

Countries

Switzerland

Central Contacts

Sabine Schoenfeld, MD

Role: CONTACT

sabine.schoenfeld@srrws.ch

0041817725662

Volha Berning, MD

Role: CONTACT

volha.berning@srrws.ch

0041817725654

Facility Contacts

Sabine Schoenfeld, MD

Role: primary

sabine.schoenfeld@srrws.ch

0041817725662

Volha Berning, MD

Role: backup

volha.berning@srrws.ch

0041817725654

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.

Reference Type: BACKGROUND

PMID: 17400530 (View on PubMed)

Related Links

http://www.ncbi.nlm.nih.gov/pubmed

pubmed

Other Identifiers

EKSG 13/126

Identifier Type: -

Identifier Source: org_study_id