NCT05448586

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
132

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Feb 2019

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 2, 2019

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 30, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 30, 2021

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2022

Completed
6 months until next milestone

First Posted

Study publicly available on registry

July 7, 2022

Completed
Last Updated

July 7, 2022

Status Verified

February 1, 2021

Enrollment Period

2 years

First QC Date

January 12, 2022

Last Update Submit

July 4, 2022

Conditions

Cervix CancerEndometrial CancerOvarian CancerBreast Cancer

Keywords

OpioidOpioid Free AnesthesiaSIRS (Systemic Inflammatory Response)Postoperative infection

Outcome Measures

Primary Outcomes (3)

  • Postoperative Systemic Inflammatory Response (C-Reactive Protein)

    To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level

    48 hours after surgery

  • Postoperative Systemic Inflammatory Response (Leucocytes Ratio)

    To compare postoperative SIRS (Systemic Inflammatory Response) with Leucocytes Ratio

    48 hours after surgery

  • Postoperative Systemic Inflammatory Response (Platelet Level)

    To compare postoperative SIRS (Systemic Inflammatory Response) with Platelet Level

    48 hours after surgery

Secondary Outcomes (5)

  • Time spent in the Post-Anesthesia Care Unit (PACU)

    30 days after surgery

  • Hospital stay

    30 days after surgery

  • Rate of later postoperative complications

    3 months after surgery

  • Number of Participants with Cancer recurrence after surgery

    12 months after surgery

  • Number of patients who Survive 12 months after surgery

    12 months after surgery

Study Arms (2)

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

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.

Interventions

OpioidDRUG

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

Also known as: Opioid Free Anesthesia
Balanced anesthesia with opioids

Eligibility Criteria

Age20 Years - 91 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailspatients who Major Surgery for gynecologic cancers (cervix, endometrial, ovarian, vaginal, vulvar and breast cancer)
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Julia Albano Polo

Madrid, 28046, Spain

Location

Related Publications (5)

  • 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.

    PMID: 28894976BACKGROUND

  • 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.

    PMID: 31298153RESULT

  • Rossaint J, Zarbock A. Perioperative Inflammation and Its Modulation by Anesthetics. Anesth Analg. 2018 Mar;126(3):1058-1067. doi: 10.1213/ANE.0000000000002484.

    PMID: 28922235RESULT

  • 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.

    PMID: 26497721RESULT

  • 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.

    PMID: 30252709RESULT

MeSH Terms

Conditions

Uterine Cervical NeoplasmsEndometrial NeoplasmsOvarian NeoplasmsBreast Neoplasms

Interventions

Analgesics, Opioid

Condition Hierarchy (Ancestors)

Uterine NeoplasmsGenital Neoplasms, FemaleUrogenital NeoplasmsNeoplasms by SiteNeoplasmsUterine Cervical DiseasesUterine DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesEndocrine Gland NeoplasmsOvarian DiseasesAdnexal DiseasesEndocrine System DiseasesGonadal DisordersBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

NarcoticsCentral Nervous System DepressantsPhysiological Effects of DrugsPharmacologic ActionsChemical Actions and UsesAnalgesicsSensory System AgentsPeripheral Nervous System AgentsCentral Nervous System AgentsTherapeutic Uses

Study Officials

  • Nicolas Brogly, PhD

    Hospital Universitario La Paz

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 12, 2022

First Posted

July 7, 2022

Study Start

February 2, 2019

Primary Completion

January 30, 2021

Study Completion

January 30, 2021

Last Updated

July 7, 2022

Record last verified: 2021-02

Locations

ES(1)