Clinical trial NCT05448586: Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?
Official title: Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cervix Cancer
Endometrial Cancer
Ovarian Cancer
Breast Cancer
Keywords: Opioid
Opioid Free Anesthesia
SIRS (Systemic Inflammatory Response)
Postoperative infection
Lead sponsor: Instituto de Investigación Hospital Universitario La Paz
Sponsor class: OTHER
First posted: 2022-07-07
Enrollment: 132
Sex: FEMALE
Minimum age (years): 20
Maximum age (years): 91
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_CONTROL
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 132 women, aged 20-91 years old and ASA I-IV, 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. They had surgery between February 2019 and February 2020 in Hospital La Paz de Madrid.

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

Eligibility criteria: 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.

Primary outcomes:
measure: Postoperative Systemic Inflammatory Response (C-Reactive Protein)
timeFrame: 48 hours after surgery
measure: Postoperative Systemic Inflammatory Response (Leucocytes Ratio)
timeFrame: 48 hours after surgery
measure: Postoperative Systemic Inflammatory Response (Platelet Level)
timeFrame: 48 hours after surgery
Secondary outcomes:
measure: Time spent in the Post-Anesthesia Care Unit (PACU)
timeFrame: 30 days after surgery
measure: Hospital stay
timeFrame: 30 days after surgery
measure: Rate of later postoperative complications
timeFrame: 3 months after surgery
measure: Number of Participants with Cancer recurrence after surgery
timeFrame: 12 months after surgery
measure: Number of patients who Survive 12 months after surgery
timeFrame: 12 months after surgery
Other outcomes:
Locations:
city: Madrid
country: Spain
facility: Julia Albano Polo
Study officials:
affiliation: Hospital Universitario La Paz
name: Nicolas Brogly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Dubowitz JA, Sloan EK, Riedel BJ. Implicating anaesthesia and the perioperative period in cancer recurrence and metastasis. Clin Exp Metastasis. 2018 Apr;35(4):347-358. doi: 10.1007/s10585-017-9862-x. Epub 2017 Sep 11.
citation: Malo-Manso A, Raigon-Ponferrada A, Diaz-Crespo J, Escalona-Belmonte JJ, Cruz-Manas J, Guerrero-Orriach JL. Opioid Free Anaesthesia and Cancer. Curr Pharm Des. 2019;25(28):3011-3019. doi: 10.2174/1381612825666190705183754.
citation: Rossaint J, Zarbock A. Perioperative Inflammation and Its Modulation by Anesthetics. Anesth Analg. 2018 Mar;126(3):1058-1067. doi: 10.1213/ANE.0000000000002484.
citation: Byrne K, Levins KJ, Buggy DJ. Can anesthetic-analgesic technique during primary cancer surgery affect recurrence or metastasis? Can J Anaesth. 2016 Feb;63(2):184-92. doi: 10.1007/s12630-015-0523-8.
citation: Brown EN, Pavone KJ, Naranjo M. Multimodal General Anesthesia: Theory and Practice. Anesth Analg. 2018 Nov;127(5):1246-1258. doi: 10.1213/ANE.0000000000003668.