Evaluation of the Effectiveness of the Administration of Local Anesthetics Via Two Catheters Placed During Surgery, and Study of the Benefits on Respiratory Function and Therefore on Recovery Time
NCT Number: NCT06463899
Acronym: PARALSTER
Status: RECRUITING
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Duration of Hospitalization in Intensive Care Unit
Interventions: PROCEDURE: multi-perforated catheter|PROCEDURE: Classic procedure
Sponsor: CHU de Reims
Sex: ALL
Age: OLDER_ADULT
Enrollment: 114
Study Design: Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: NONE|Primary Purpose: SUPPORTIVE_CARE
Start Date: 2023-02-08
Completion Date: 2025-02-08
Locations: Damien JOLLY, Reims, France

Summary:
Currently intravenous analgesics are used for postoperative analgesia. But the analgesia of these products is tempered by their adverse effects (sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus) which can slow down postoperative recovery.

The aim of this study is to evaluate the effectiveness of the administration of local anesthetics via two catheters placed during surgery, but also to study their benefit on respiratory function and therefore on recovery time and morphine sparing.

Primary Outcome Measures: Evaluation of the duration of hospitalization in intensive care unit, Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on recovery time versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects, and can slow down postoperative recovery., Day 1
Secondary Outcome Measures: Evaluation of the pain at rest and on mobilization using a visual pain evaluation scale, Study of the effectiveness of the administration of local anesthetics via two catheters placed during surgery, including their benefit on respiratory function, versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects., Day 2|Evaluation of the total consumption of opioids, Study of the use of local anesthetics via two catheters placed during surgery for morphine sparing versus the use of currently intravenous analgesics that are used for postoperative analgesia which are multimodal analgesia combining opioids like nefopam, nonsteroidal anti-inflammatory drugs, ketamine, lidocaine and paracetamol, At 48 hours|Evaluation of the patient mortality, Study of the benefit of the administration of local anesthetics via two catheters placed during surgery on respiratory function and complications which remains a significant cause of morbidity and mortality versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects., Day 30|Evaluation of the occurrence of the side effects of opioids, Study of the benefit of the administration of local anesthetics via two catheters placed during surgery versus currently intravenous analgesics that are used for postoperative analgesia, which are tempered by their adverse effects as sedation, confusion, nausea or vomiting, delayed transit, urinary retention and pruritus., At 48 hours