Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?

Study Overview
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Brief Summary
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Opioid Free Anesthesia (OFA) is a multimodal anesthesia and emerging technique that spares the use of opioids and involve other adjuvant anesthetics, which have demonstrated in vitro influence on immunologic and inflammatory response, as well as in metastatic progression. For these reasons we believe that OFA may positively influence in oncologic patients postoperative recovery and in its disease progression.

Detailed Description
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After Local Ethics Committee approval, consecutive consenting patients scheduled for major gynecologic oncologic surgery were included between February 2019 and January 2020 in this observational retrospective study. We Compared OFA to standard technique used in our institution and assessed its effect on Postoperative Systemic Inflammatory Response (SIRS), hospital stay, postoperative complications in the following 2 months, cancer progression and mortality 6 months and 12 months after surgery. OFA protocol consisted of a Total IntraVenous Anaesthesia of Propofol, a Dexmedetomidine infusion of 0,8-1,0 mcg/kg/h, together with 0,2-0,3 mg/kg ketamine and lidocaine 1,5 mg/kg in the first hour of surgery. The standard anaesthetic protocol included opioids (Fentanyl 2mcg/kg at induction, and remifentanyl infusion 0,1-0,2 mcg/kg/min) and volatile agents (sevoflurane or desflurane). Patients in both groups received a regional block when possible, dexamethasone 8 mg at induction and paracetamol 1g plus dexketoprofen 50mg at the end of surgery. Continuous variables were compared using unpaired t-test (or Mann-Whitney U test) and categorical variables by Chi-square test. Statistical significance was set at p < 0.05

Official Title
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Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study

Conditions
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Cervix Cancer, Endometrial Cancer, Ovarian Cancer, Breast Cancer

Intervention / Treatment
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* Drug: Opioid


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, both combined with regional anesthesia. Exclusion Criteria: Patients who had Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer) under OFA and balanced anesthesia with opioids, but had later surgery with a different to previous anesthesia technique. Patients who had no later follow up during 12 months in the same Hospital, so we cannot register recurrence.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 91 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Balanced anesthesia with opioids<br>Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under balanced anesthesia including opioids between February 2019 and 2020 in Hospital La Paz. | Drug: Opioid<br>* Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery<br>* Other names: Opioid Free Anesthesia;|
| Opioid Free Anesthesia (OFA)<br>Patients who had Major Surgery for gynecologic cancers (cervix, endometrium, ovarian and breast cancer) under Opioid Free anesthesia between February 2019 and 2020 in Hospital La Paz. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Postoperative Systemic Inflammatory Response (C-Reactive Protein) | To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level | 48 hours after surgery | 
| Postoperative Systemic Inflammatory Response (Leucocytes Ratio) | To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio | 48 hours after surgery | 
| Postoperative Systemic Inflammatory Response (Platelet Level) | To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level | 48 hours after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Time spent in the Post-Anesthesia Care Unit (PACU) | To compare recovery time between groups | 30 days after surgery | 
| Hospital stay | To compare hospital stay in both groups | 30 days after surgery | 
| Rate of later postoperative complications | Complications due to surgery which required hospitalization | 3 months after surgery | 
| Number of Participants with Cancer recurrence after surgery | To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups. | 12 months after surgery | 
| Number of patients who Survive 12 months after surgery | To compare cancer survival 12 months after surgical treatment between groups | 12 months after surgery | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Opioid, Opioid Free Anesthesia, SIRS (Systemic Inflammatory Response), Postoperative infection