A Phase 4 interventional study of Sufentanil and Ketamine in Thoracic Surgery, sponsored by Hopital Foch. Terminated at 1 site in France. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-09-23.
Sponsored by Hopital Foch · Phase 4, Interventional, and Treatment
Thoracic epidural analgesia is often proposed to thoracotomized patients. A local anesthetic and an opioid are generally associated to produce an epidural analgesia. However, opioid epidural administration is frequently associated with adverse effects as nausea, vomiting, urinary retention, ... On the other hand, iv ketamine has been demonstrated to be an effective analgesic.
The purpose of the study is to compare the epidural administration of levobupivacaine and sufentanil or the epidural administration of levobupivacaine associated with the iv administration of ketamine.
Hopital Foch is the lead sponsor of 208 studies on the registry; 21 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Epidural infusion of levobupivacaine and saline (placebo for sufentanil)and iv infusion of ketamine Up to the third postoperative day (6 PM)
Drug: Ketamine
Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)
Drug: Sufentanil
Epidural infusion of levobupivacaine (1,25 mg/ml) and sufentanil(1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of saline (placebo for ketamine)
Epidural infusion of levobupivacaine (1,25 mg/ml) and saline (1 ml = 50 µg diluted in the 200 ml bag of levobupivacaine) IV infusion of ketamine (2 µg/kg/minute) Up to the third postoperative day (6 PM)
Occurrence of an adverse event due to the analgesic protocol
Time frame: one week
Efficacy of the analgesic regimen
Time frame: third postoperative day
postoperative rehabilitation
Time frame: two weeks
postoperative complications (pulmonary, others)
Time frame: one month
length of stay
Time frame: one month
patient's satisfaction
Time frame: sortie de l'hopital
Occurence of a chronic pain
Time frame: end the first postoperative year
This study is terminated, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.
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Hopital Foch