NCT04797312

Comparison of an Opioid-Free Anesthesia Protocol Versus Standard Practices on Early and Late Post-operative Recovery

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 140 (estimated)
• Sponsor: University Hospital, Angers · Other Government
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Opioid-Free Anesthesia (OFA) is an anesthesia protocol that does not use morphine, and is increasingly used routinely. Indeed, this protocol would theoretically allow a better post-operative analgesic control, a lower incidence of post-operative complications (e.g. post-operative nausea and vomiting). In the end, it would also allow a better overall post-operative recovery and a decrease in the incidence of chronic post-operative pain. Nevertheless, the literature is poor on this issue and no randomized controlled study has evaluated the effect of the use of this type of anesthesia protocol on postoperative recovery.

Conditions

• Anesthesia
• Anesthesia; Adverse Effect
• Opioid Analgesic Adverse Reaction
• Post-Op Complication

Interventions

Type	Name	Description
DRUG	Opioid Free Anaesthesia protocol	The OFA protocol begins with a systematic preoperative premedication with clonidine, continues with an adapted intraoperative management without opioid administration, but associating several molecules (clonidine, magnesium, lidocaine, ketamine) and ends with a continued administration of xylocaine up to 1 hour postoperatively in PACU. The use of an opioid in preoperative or intraoperative phases is considered as a deviation from the protocol. To these different molecules, the use of hypnotic molecules left to the choice of the practitioner and a curare will be systematically associated.
DRUG	standard practice protocol based on the use of opioids (sufentanil or remifentanil)	Standard anesthetic practices can be summed up as the combination of a hypnotic, a morphinic (sufentanil or remifentanil) and a curare. The use of ketamine is allowed.

Timeline

• Start date: 2021-07-12
• Primary completion: 2022-11-01
• Completion: 2023-05-01
• First posted: 2021-03-15
• Last updated: 2021-10-14

Locations

1 site across 1 country: France