A Phase 4 interventional study of Ropivacaine 0,75% and posterior tibial nerve block in Hallux Valgus, sponsored by Dr.med. Sabine Schoenfeld. Status unknown at 1 site in Switzerland. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-05-02.
Sponsored by Dr.med. Sabine Schoenfeld · Phase 4, Interventional, and Treatment
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.
149 studies on the registry are indexed under Hallux Valgus; 31 are open to participants now.
This study's planned enrollment of 60 is close to the median of 60 across 111 interventional studies indexed under Hallux Valgus.
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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% · Procedure: posterior tibial nerve block · Drug: morphine and droperidol
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
Ropivacaine injection
Also known as: Naropin 0,75%
ultrasound guided posterior tibal nerve block
Drug pages: Morphine · Droperidol
i.v PCA
Also known as: DHBP
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).
Time frame: 24 hours
sleeping quality
sleeping quality in the first postoperative night, questionaire
Time frame: 24 hours
The record gives a start of Oct 2014, a primary completion of Feb 2017 and a completion of Mar 2017. It does not say whether these dates are actual or estimated.
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This study is status unknown, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ropivacaine