Study of the benefits of continuous paravertebral block in the management of renal and/or adrenal surgery via laparotomy in adults - BPV

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Authors
Category Primary study
Registry of TrialsEU Clinical Trials Register
Year 2009
INTERVENTION: Trade Name: Xylocaine 2% with adrenaline Pharmaceutical Form: Solution for injection INN or Proposed INN: Lidocaine hydrochloride INN or Proposed INN: Epinephrine tartrate Trade Name: Xylocaine 1% preservative-free Pharmaceutical Form: Solution for injection INN or Proposed INN: Lidocaine hydrochloride Trade Name: Naropeine 2mg/ml Pharmaceutical Form: Solution for injection INN or Proposed INN: Ropivacaine hydrochloride Pharmaceutical form of the placebo: Solution for injection Route of administration of the placebo: Subcutaneous use CONDITION: Analgesia in the context of scheduled renal and/or adrenal surgery by laparotomy; MedDRA version: 9.1 Level: LLT Classification code 10054799 Term: Perioperative analgesia PRIMARY OUTCOME: Main Objective: The objective of our study is to demonstrate the superiority of continuous paravertebral block, as an adjunct to analgesia, in the management of renal and/or adrenal surgery via laparotomy (subcostal or lumbotomy) in adults, in terms of morphine consumption in the first 24 postoperative hours, compared to conventional systemic analgesia (PCA morphine) without paravertebral block. Primary endpoint(s): Morphine consumption in the first 24 postoperative hours. Secondary Objective: Benefits and contribution of continuous paravertebral block as an adjunct to analgesia in terms of: • General comfort: • Static and dynamic pain; - PONV (Post-Operative Nausea and Vomiting); - Sleep; - Behavior: agitation, confusion; - Mobilization (care, dressings, physiotherapy, etc.); • Rehabilitation: - Resumption of oral intake; - Deperfusion; - First mobilization; - Length of hospital stay; • Post-operative complications, particularly respiratory (record of pneumonias); INCLUSION CRITERIA: - American Society of Anesthesiologists (ASA) score: ASA I, II, III - Patient scheduled for planned renal and/or adrenal surgery via laparotomy - Adult patients - Patients who have given their free and informed consent in writing 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: aadb7aa7fde1a54bed7317a27e708ca603d11615
First added on: Aug 22, 2024
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