Immediate Severe Postoperative Pain Clinical Trial
Official title:
Effect of Targeted Analgesia to ANI (Analgesia/ Nociception Index) During General Anesthesia on Immediate Postoperative Pain and Perioperative Hemodynamic: Multicenter Randomized Controlled Study
The primary purpose of GOALDAN study is to demonstrate the superiority of a targeted
perioperative analgesic strategy by the ANI over the usual practice on the incidence of
immediate postoperative pain.
The investigators hypothesized that a prophylactic administration of morphine in patients
with risk of postoperative pain determined by the ANI at the end of the intervention would
reduce the incidence of immediate postoperative pain and that the targeted analgesia to ANI
and minimal alveolar concentration (MAC) of desflurane could improve the perioperative
hemodynamic, and the postoperative becoming.
Visits:
- The patient will arrive in the department the day before the surgical intervention
(D-1). During this preoperative visit (D-1), the investigator
- will preselect potentially eligible patients
- will offer to participate to this study
- will give the notice form to the patients
- will present the research: objectives, benefits and constraints for the patients
- will check that patients understand the verbally administered Numeric Rating Scale
(NRS) for the assessment of the postoperative This verbally administered NRS is
routinely presented to all patients at a surgical intervention.
- The intervention day (D0):
The investigator will collect the signed consent form after having ascertained the
understanding of the notice form by the patient and checking the inclusion and non-inclusion
criteria.
The randomization will be done via the eCRF module (allocation group and number) and the
preoperative data registration in the eCRF.
• Surgical intervention (D0): All patients will receive a usual multimodal analgesia
associating level 1 analgesics (acetaminophen, ketoprofen, nefopam) or level 2 (tramadol)
administered 30 to 60 min before the foreseeable end of the surgical intervention. All
patients will receive 0.1 to 0.2 mg/kg of morphine within the 30 min preceding the end of the
surgical intervention according to the usual practice.
Once the patient transferred to the recovery room, the assessment of the primary outcome
(verbally administered NRS) will be done by the nurse responsible for the patient, when the
patient arrives, during the stay and when the patient leaves the recovery room. If the
verbally NRS > 3, a morphine titration by IV administration of 2 to 3 mg of morphine will be
realised then the verbally NRS will be collected 5 min after, according to the usual
practice. This morphine titration will continued until the obtaining of a verbal NRS ≤ 3.
As an alternative to this morphine titration, where possible, a peripheral nerve block may be
proposed to the patient and performed by the investigator to relieve the patient.
If the patient is transferred directly in ICU without being extubated at the end of the
intervention and so without transiting by the recovery room, the patient will be excluded
from the study.
;