Comparison between two methods of post-operative analgesia after thoracotomy: epidural administration of sufentanil and levobupivacaine and epidural administration of levobupivacaine associated with intravenous infusion of ketamine (Monocentric, prospective, randomized, double-blind study)

Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: KETAMINE PANPHARMA 50 mg Product Name: Kétamine Panpharma 50 mg Pharmaceutical Form: Solution for injection Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Sufenta Product Name: Sufenta Pharmaceutical Form: Solution for infusion Pharmaceutical form of the placebo: Solution for infusion Route of administration of the placebo: Intravenous use Trade Name: Chirocaine Product Name: Chirocaine 2.5 Pharmaceutical Form: Intravenous infusion Trade Name: chirocaine 1.25 Product Name: Chirocaine 1.25 Pharmaceutical Form: Solution for infusion CONDITION: postoperative epidural analgesia ; MedDRA version: 9.1 Level: LLT Classification code 10054891 Term: Epidural analgesia PRIMARY OUTCOME: Main Objective: Main objective is to compare the side effects and the efficacy of postoperative analgesia between two groups of patients : ; ‐ one group will receive epidural administration of sufentanil and levobupivacaine and iv saline (as the placebo for iv ketamine); ‐ the other group will receive epidural administration of levobupivacaine associated with intravenous infusion of ketamine and epidural saline (as the placebo for epidural levobupivacaine ) Primary end point(s): ‐ side effects due to epidural analgesia or ketamine infusion; ‐ efficacy of both regimens; Secondary Objective: The secondary objectives relate to post‐operative rehabilitation, post‐operative complications, quality of life, patient satisfaction, length of hospitalization, occurrence of chronic pain of neuropathic origin INCLUSION CRITERIA: ‐ aged 18 ‐ 75 years ‐ ASA class I to III, ‐ lung resection (posterior‐lateral or axillary thoracotomy) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18‐64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Epistemonikos ID: 2a3ea19fd0f2546f2f8c1ee9874ac93092eefe0e
First added on: Aug 22, 2024