Trial | NCT02282956  Report issue

Title

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.

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Study Participants

    60
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.
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 Started
Oct 31
2014
Primary Completion
Feb 28
2017
Anticipated
Study Completion
Mar 31
2017
Anticipated
Last Update
May 02
2016
Estimate

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

study group Experimental

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.

controll Group Other

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

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
No Results Posted