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

Sponsor

Instituto de Investigación Hospital Universitario La Paz (Other)

Overall Status

Completed

CT.gov ID

NCT05448586

Collaborator

(none)

132

Enrollment

Location

23.9

Actual Duration (Months)

5.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cervix Cancer Endometrial Cancer Ovarian Cancer Breast Cancer	Drug: Opioid

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 Design

Study Type:

Observational

Actual Enrollment :

132 participants

Observational Model:

Case-Control

Time Perspective:

Retrospective

Official Title:

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

Actual Study Start Date :

Feb 2, 2019

Actual Primary Completion Date :

Jan 30, 2021

Actual Study Completion Date :

Jan 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Balanced anesthesia with opioids 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 Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery Other Names: Opioid Free Anesthesia
Opioid Free Anesthesia (OFA) 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.

Arm

Intervention/Treatment

Balanced anesthesia with opioids

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

Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery

Other Names:

Opioid Free Anesthesia

Opioid Free Anesthesia (OFA)

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.

Outcome Measures

Primary Outcome Measures

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
Postoperative Systemic Inflammatory Response (Platelet Level) [48 hours after surgery]
To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level

Secondary Outcome Measures

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
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.
Number of patients who Survive 12 months after surgery [12 months after surgery]
To compare cancer survival 12 months after surgical treatment between groups

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 91 Years

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.