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

Instituto de Investigación Hospital Universitario La Paz

Status: Completed

Conditions: Endometrial Cancer; Breast Cancer; Ovarian Cancer; Cervix Cancer

Treatments: Drug: Opioid

Study type: Observational

Funder types: Other

Identifiers

NCT05448586

PI-3958

Details and patient eligibility

About

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.

Full 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

Enrollment: 132 patients

Sex: Female

Ages: 20 to 91 years old

Volunteers: No 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.

Trial design

132 participants in 2 patient groups

Balanced anesthesia with opioids

Description:

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.

Treatment:

Drug: Opioid

Opioid Free Anesthesia (OFA)

Description:

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.