Clinical trial · Observational
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit?
Opioid Free Anaesthesia in Oncologic Gynaecological Surgery: Is There Any Benefit? Retrospective Observational Study
NCT05448586CI-TRIAL-00059535completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Cervix Cancer | — | UNRESOLVED | — |
| Endometrial Cancer | Malignant Endometrial Neoplasm | CURATED_BROADER | 0.80 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Opioid | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- label
- 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.
- interventionNames
- Drug: Opioid
- label
- 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.
Primary outcomes (3)
- measure
- Postoperative Systemic Inflammatory Response (C-Reactive Protein)
- timeFrame
- 48 hours after surgery
- description
- To compare postoperative SIRS (Systemic Inflammatory Response) with C-Reactive Protein plasmatic level
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 20 Years
- Maximum age
- 91 Years
Show eligibility criteria text
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.
References
Publications (5)
- BACKGROUNDDubowitz 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 28894976
- RESULTMalo-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 31298153
- RESULTRossaint J, Zarbock A. Perioperative Inflammation and Its Modulation by Anesthetics. Anesth Analg. 2018 Mar;126(3):1058-1067. doi: 10.1213/ANE.0000000000002484. PMID 28922235
- RESULTByrne 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 26497721
- RESULTBrown 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 30252709