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Cervix CancerNCT05448586

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

An observational study of Cervix Cancer and Endometrial Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 20 to 91 years, women only
Conditions the study is for
Cervix Cancer, Endometrial Cancer, Ovarian Cancer
What is being tested?
Opioid
How many people
132 participants
Where
1 siteSpain
Study dates
2 Feb 2019to 30 Jan 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 91 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

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.

Who may be able to join

  • 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.

Who cannot join

  • 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 locations and contacts

1 site in 1 country.

Spain1 site

  • Julia Albano Polo

    Madrid, 28046

Other trials in Spain

About this study

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

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.

Read the 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

Being tested
Opioid
Keywords
Opioid, Opioid Free Anesthesia, SIRS (Systemic Inflammatory Response), Postoperative infection
Medical subject headings
Uterine Cervical Neoplasms, Endometrial Neoplasms, Ovarian Neoplasms, Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OpioidDrug

    Also called Opioid Free Anesthesia

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

Study groups in NCT05448586
Study groupRoleWhat they receive
Balanced anesthesia with opioidsPatients 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.
Receives: 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Postoperative Systemic Inflammatory Response (C-Reactive Protein)

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

    Measured: 48 hours after surgery

  2. Postoperative Systemic Inflammatory Response (Leucocytes Ratio)

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

    Measured: 48 hours after surgery

  3. Postoperative Systemic Inflammatory Response (Platelet Level)

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

    Measured: 48 hours after surgery

Secondary outcomes (5)

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

    To compare recovery time between groups

    Measured: 30 days after surgery

  2. Hospital stay

    To compare hospital stay in both groups

    Measured: 30 days after surgery

  3. Rate of later postoperative complications

    Complications due to surgery which required hospitalization

    Measured: 3 months after surgery

  4. Number of Participants with Cancer recurrence after surgery

    To compare cancer recurrence (local and/or metastatic) 12 months after surgical treatment between groups.

    Measured: 12 months after surgery

  5. Number of patients who Survive 12 months after surgery

    To compare cancer survival 12 months after surgical treatment between groups

    Measured: 12 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jul 2022
  2. Study start2 Feb 2019
  3. Primary completion30 Jan 2021
  4. Study completion30 Jan 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Case-control
Time perspective
Retrospective
Enrolment
132 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05448586
Sponsor's protocol ID
PI-3958
Status last verified
Feb 2021
First submitted
12 Jan 2022
Last updated
7 Jul 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • 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.

    PubMed 28894976

  • 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.

    PubMed 31298153

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

    PubMed 28922235

  • 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.

    PubMed 26497721

  • 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.

    PubMed 30252709

Questions about this trial

What is this clinical trial studying?

An observational study of Cervix Cancer and Endometrial Cancer, run by Instituto de Investigación Hospital Universitario La Paz at 1 site in Spain.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Jul 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Postoperative Systemic Inflammatory Response (C-Reactive Protein) (time frame: 48 hours after surgery). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05448586, which also lists 5 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2022.

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