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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05448586
• Other study ID #: PI-3958
• Status: Completed
• Start date: February 2, 2019
• Est. completion date: January 30, 2021

Study information

• Verified date: February 2021
• Source: Instituto de Investigación Hospital Universitario La Paz
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 132
• Est. completion date: January 30, 2021
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 20 Years to 91 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Cervix Cancer
• Endometrial Cancer
• Endometrial Neoplasms
• Ovarian Cancer
• Uterine Cervical Neoplasms

Intervention

Drug:
• Opioid
Use of balanced anesthesia including opioids during anesthesia for gynecologic cancer surgery

Locations

Country	Name	City	State
Spain	Julia Albano Polo	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto de Investigación Hospital Universitario La Paz

Country where clinical trial is conducted

Spain, 

References & Publications (5)

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. Review. — View 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. Review. — View 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. Review. — View Citation

Malo-Manso A, Raigon-Ponferrada A, Diaz-Crespo J, Escalona-Belmonte JJ, Cruz-Mañas J, Guerrero-Orriach JL. Opioid Free Anaesthesia and Cancer. Curr Pharm Des. 2019;25(28):3011-3019. doi: 10.2174/1381612825666190705183754. Review. — View 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. Review. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Postoperative Systemic Inflammatory Response (C-Reactive Protein)	To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level	48 hours after surgery
Primary	Postoperative Systemic Inflammatory Response (Leucocytes Ratio)	To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio	48 hours after surgery
Primary	Postoperative Systemic Inflammatory Response (Platelet Level)	To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level	48 hours after surgery
Secondary	Time spent in the Post-Anesthesia Care Unit (PACU)	To compare recovery time between groups	30 days after surgery
Secondary	Hospital stay	To compare hospital stay in both groups	30 days after surgery
Secondary	Rate of later postoperative complications	Complications due to surgery which required hospitalization	3 months after surgery
Secondary	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
Secondary	Number of patients who Survive 12 months after surgery	To compare cancer survival 12 months after surgical treatment between groups	12 months after surgery