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

Completed

• Conditions: Endometrial Cancer; Breast Cancer; Cervix Cancer; Ovarian Cancer
• Interventions: Drug: Opioid

• Registration Number: NCT05448586
• Lead Sponsor: Instituto de Investigación Hospital Universitario La Paz

Brief Summary

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

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

Study Timeline

• Study Start: 2019-02-02
• Primary Completion: 2021-01-30
• Study Completion: 2021-01-30
• Status Verified: 2021-02
• Study First Submitted: 2022-01-12
• Study First Submitted QC: 2022-07-04
• Last Update Submitted: 2022-07-04
• Study First Posted: 2022-07-07
• Last Update Posted: 2022-07-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 132

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Balanced anesthesia with opioids	Opioid	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.

Primary Outcome Measures

Name	Time	Method
Postoperative Systemic Inflammatory Response (Platelet Level)	48 hours after surgery	To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level
Postoperative Systemic Inflammatory Response (C-Reactive Protein)	48 hours after surgery	To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level
Postoperative Systemic Inflammatory Response (Leucocytes Ratio)	48 hours after surgery	To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Julia Albano Polo; 🇪🇸 Madrid, Spain