Immediate Severe Postoperative Pain Clinical Trial
— GOALDANOfficial 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.
| Status | Recruiting |
| Enrollment | 380 |
| Est. completion date | August 13, 2022 |
| Est. primary completion date | May 13, 2022 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 65 Years |
| Eligibility |
Inclusion Criteria: - 18= Age <65 years old - Patient operated on a scheduled surgery under general anesthesia - Patient with a American Society of Anesthesiologists (ASA) score of I to III - Patient having given his consent in the manner described in Article L1122-1-1 of the Public Health Code - Patient affiliated with a social security regimen or beneficiary of such a regimen Exclusion Criteria: - general anesthesia without extubating (laryngeal mask) - neuraxial preoperative regional anesthesia (epidural or rachianalgesia) - opioid-free anesthesia - preoperative peripheral nerve block with analgesic aim (infiltration of a local surgical anesthetic or transversus abdominis plane block-TAP block-authorized) - arrhythmia or the presence of a pacemaker - ambulatory surgery - cardiac or cerebral surgery - obstetrical surgery (caesarean) - surgery performed with neuraxial regional anesthesia or peripheral anesthesia alone - surgery performed in prone position - urgent surgery - endoscopic procedure or interventional radiology - chronic pain treated with opiates - expected surgery duration < 1h - pathology of the autonomic nervous system (epilepsy, history of transient attack or stroke, paraplegia, hemiplegia, orthostatic hypotension, autonomic dysfunction) - Patient with cardiogenic or septic shock - Continuous infusion of vasoactive agents (ephedrine, phenylephrine, adrenaline, or noradrenaline) - Postoperative transfer planned in intensive care unit (intubated patient) after surgery - Person under tutorship or curatorship - Pregnancy - Breastfeeding |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Clermont-Ferrand | Clermont-Ferrand | Auvergne |
| Lead Sponsor | Collaborator |
|---|---|
| University Hospital, Clermont-Ferrand | Fondation Apicil |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | immediate maximum postoperative pain in recovery room defined by a score > 3 on a verbally administered numeric rating scale (NRS) variating from 0 to 10. | 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 | From day 0 to day 28 | |
| Secondary | Maximum pain score during the first postoperative day (numeric rating scale variating from 0 to 10). | The patient chooses on a scale numeric range a number between 0 and 10 to characterise the intensity of the pain during the first postoperative day : 0 if the pain is mild (better outcome), 10 if the pain is severe (worse outcome).This numeric rating scale will be assessed every 6 hours during the 24 first hours (H0 = arrival hour at the recovery room). | every 6 hours during the 24 first hours. | |
| Secondary | Score Postoperative D1 Pain Management (numeric rating scale variating from 0 to 10) | The patient chooses on a scale numeric range from 0 to 10, a number which characterises the overall satisfaction of pain management : if the pain management is correct (10) or if the pain management is not correct (0). | At day 1 | |
| Secondary | dose of morphine in the recovery room | will be compared between groups by test t of Student or test not parametrize of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariate preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %. | At day 0 | |
| Secondary | postoperative nausea and vomiting in the recovery room | In both groups, the prevention of the nausea and the vomitings will be administered according to the current recommendations (dexamethasone 4 mg and droperidol 0,625-1,25 mg it peroperatoire at the patients at risk, defined by a score of Apfel 2). In case of NVPO during the first 24 post-operative hours, the administration of 4 mg of ondansétron will be realized, according to the recommendations. | At day 1 | |
| Secondary | total dose of morphine during the first postoperative day (mg) | will be compared between groups by test t of Student or test not parametrique of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %. | At day 1 | |
| Secondary | regional anesthesia for postoperative analgesic purposes | At day 1 | ||
| Secondary | the duration in the recovery room (time to obtain an Aldrete score =9) (min) | will be compared between groups by test t of Student or test not parametrize of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscedasticity studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %. | From day 0 to day 28 | |
| Secondary | destination of the patient after surgery (unit of surgery, continuous care, resuscitation). | Test of chi² or exact test of Fisher if necessary. Secondly, this analysis can be completed, in multivariate situation, by a mixed generalized linear model of logistic type allowing to take into account variability inter and intracentre. Covariables will be considered with regard to the clinical relevance (other treatments, use of vasopresseurs continuous, type of surgery) and results of analyses univariate preliminary. The results will be expressed in terms of reports of the quotations and the reliable intervals in associated 95 %. | From day 0 to day 28 | |
| Secondary | incidence of postoperative complications on the first and seventh postoperative days for hospitalized patients using Post-Operative Morbidity Survey (POMS). | Post-operative complications in the first and seventh day post-operative will be compared by test of chi² or where necessary, by the exact test of Fisher. Secondly, this analysis can be completed, in multivariate situation, by a mixed generalized linear model of logistic type allowing to take into account variability inter and intracentre. Covariables will be considered with regard to the clinical relevance (other treatments, use of vasopresseurs continuous, type of surgery) and results of analyses univariées preliminary. The results will be expressed in terms of reports of the quotations and the reliable intervals in associated 95 %. |
From day 0 to day 1 and until day 7 | |
| Secondary | duration of the hospitalization (day) | Duration of hospitalization will be compared between groups by test t of Student or test not paramétrique of Mann-Whitney if the conditions of the test t are not respected (study of the normality, homoscédasticité studied by test of Fisher-Snedecor). The results will be expressed in terms of size of effect and reliable interval in associated 95 %. These analyses can be secondly completed, in multivariate situation, by models of regression of linear type; covariables will be considered with regard to the clinical relevance and the results of analyses univariées preliminary. The results will be expressed in terms of coefficients of regression and reliable intervals in associated 95 %. | From day 0 to day 28 | |
| Secondary | Mortality at Day 28 | The survival to day 28 comment surgery will be estimated(esteemed) by curve of Kaplan-Meier and compared between groups of randomization by test of the log-rank in univariate situation and model of Cox in multivariated analysis. The results will be expressed in terms of relationship of immediate risks and reliable intervals in associated 95 %. | At day 28 |