A Phase 1/2 interventional study of Opioid-Free Anesthesia (OFA) and Opioid-Based Anesthesia (OBA) in Pain Management, Colorectal Surgery and Opioid Free Anesthesia, sponsored by Hospital Universitario La Fe. Active, not recruiting at 2 sites in Spain. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2026-08-18.
Sponsored by Hospital Universitario La Fe · Phase 1/2, Interventional, and Prevention
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Among 69 studies in Postoperative Complications with a site in Spain — 13 open to participants now, 15 under way, 1 of them phase 3. Postoperative Complications · Spain.
Among the 69 studies in Postoperative Complications with a site in Spain, this one is the 16th largest by planned enrollment of the 32 interventional ones that give a count, is one of 5 that started in 2025, is the only one in phase 1/2, reaches primary completion later than 10 of the 14 other live ones, and was the 68th registered.
1,335 studies on the registry are indexed under Postoperative Complications; 310 are open to participants now.
Browse Postoperative Complications studies →13 of the 69 studies in Postoperative Complications with a site in Spain are open now. Recruiting first, the newest first:
University of Seville · Sites in Spain
Ages 18–80
Zealand Pharma · Sites in Spain, United States, Austria and 11 more countries
Ages 18–90
Carlos Alfredo Fraile Olivero, MD, PhD. · Sites in Spain
Ages 18+
Francisco Andres de la Gala · Sites in Spain
Ages 18+
Hospital Universitario de Gran Canaria Doctor Negrín · Sites in Spain
Ages 18+
A study can be open while its sites in Spain have not opened yet or have stopped. Only those recruiting at a site in Spain →
Of the 201 Postoperative Complications studies recruiting now, 125 (62%) set no upper age limit and 32 (16%) stop at 75 or younger; 25 take children under 18; 25 take healthy volunteers.
This study: 18 Years to 90 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
69 studies; the count open now beside each. This study's row is marked.
First in 1998; this study’s year is marked. 5 started in 2025.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 200 is above the median of 115 across 768 interventional studies indexed under Postoperative Complications.
Median enrollment 189 across the 32 interventional studies, 400 across the 37 observational. Of the 41 that completed or were terminated, 3 (7%) have results posted.
This tab as a report to print or save as PDF → With an account.
3 of 69 have an industry lead sponsor. The 10 most frequent:
Hospital Universitario La Fe is the lead sponsor of 39 studies on the registry; 5 are open to participants now.
Hospital Universitario La Fe has 2 studies filed under Postoperative Complications — fewer than ten, so there is no comparison to draw.
5 of the studies in Postoperative Complications with a site in Spain that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT04973397Centre hospitalier de l'Université de Montréal (CHUM)Vascular Events In Patients Undergoing Same-day Noncardiac Surgery (VALIANCE) Study | 2026-12 |
| NCT04794582Fundacion para la Investigacion Biomedica del Hospital Universitario Ramon y CajalPrevention of Incisional Hernia After Renal Transplantation | 2026-12 |
| NCT07461779Francisco Andres de la GalaEffect of Oxygen Administration in the Non-dependent Lung on Postoperative Complications After Lung Surgery | 2026-12-30 |
| NCT06732193Carlos Alfredo Fraile Olivero, MD, PhD.Fissios© and Postoperative Complications (FPoC Trial) | 2026-12-31 |
| NCT07771049Hospital Universitario La FeOpioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025) | 2027-07-20 |
Add all 5 to your calendar (.ics) → With an account.
Among the 69 studies in Postoperative Complications with a site in Spain, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This study wants to find out if using a pain control method without opioids (Opioid-Free Anesthesia or OFA) works as well as or better than standard anesthesia (which uses opioids) for adults having minimally invasive (laparoscopic) colorectal surgery. Opioids are strong pain medicines often used during surgery, but they can cause side effects like nausea, vomiting, slower digestion, and breathing problems.
Researchers will divide participants into two groups by chance (like flipping a coin). One group will receive the opioid-free anesthesia, which uses a combination of other types of pain medicines. The other group will receive standard anesthesia with opioids. The main goal is to see if the opioid-free method reduces pain and the need for extra pain medicine in the first 24 hours after surgery. The study will also look at whether patients have fewer side effects, wake up more comfortably, and can leave the hospital sooner.
Postoperative pain management is a critical component of Enhanced Recovery After Surgery (ERAS) pathways, particularly in major abdominal procedures such as laparoscopic colorectal surgery. Traditionally, intraoperative and postoperative analgesia relies heavily on opioid administration. However, opioid use is frequently associated with adverse events-including postoperative nausea and vomiting (PONV), paralytic ileus, respiratory depression, and hyperalgesia-which can delay functional recovery and prolong hospital stays.
Opioid-Free Anesthesia (OFA) is a multimodal analgesic strategy that utilizes non-opioid pharmacological agents to block sympathetic nervous system responses and prevent central sensitization. This study is a prospective, single-blind, randomized controlled trial designed to evaluate the efficacy and safety of an OFA protocol compared to standard Opioid-Based Anesthesia (OBA). The OFA protocol utilizes a customized combination of agents, including Dexmedetomidine, Ketamine, Lidocaine, Magnesium Sulfate, and Dexamethasone.
Eligible adult patients (ASA I-III) scheduled for elective laparoscopic colorectal surgery will be randomized in a 1:1 ratio to either the OFA or OBA group. Standardized clinical pathways will be followed for all patients outside of the specific anesthetic interventions. Data collection will occur from the intraoperative period through 24 hours post-surgery, with continuous follow-up extending until hospital discharge.
By comparing these two approaches, this trial aims to provide robust clinical evidence on whether completely eliminating intraoperative opioids can optimize postoperative pain control, reduce the incidence of classic opioid-related adverse effects, enhance overall patient satisfaction, and accelerate surgical recovery in colorectal patients.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
ASA physical status
The anaesthetists’ scale of health before surgery: I is healthy, II has a mild illness that is under control, III a severe one, IV a severe illness that is a constant threat to life. V and VI are used for the critically ill and for organ donors.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intervention Type: Drug Name: Opioid-Free Anesthesia Protocol Description: Multimodal non-opioid intraoperative anesthesia including Dexmedetomidine, Lidocaine, Ketamine, Magnesium Sulfate, and Dexamethasone.
Drug: Opioid-Free Anesthesia (OFA)
Intervention Type: Drug Name: Opioid-Based Anesthesia Protocol Description: Standard of care intraoperative anesthesia utilizing opioids (e.g., Fentanyl, Remifentanil) for induction and maintenance and morphine for postoperative pain management.
Drug: Opioid-Based Anesthesia (OBA)
Administration of a multimodal non-opioid protocol including a pre-induction load of Dexmedetomidine, and an induction/maintenance infusion mixture of Dexmedetomidine, Lidocaine, and Ketamine. Adjuncts include Magnesium Sulfate, Dexamethasone, and NSAIDs.
Administration of standard of care intraoperative anesthesia utilizing intravenous opioids (e.g., Fentanyl, Remifentanil) for the induction and maintenance of analgesia, and morphine for postoperative pain; following standard and protocoliced institutional clinical guidelines.
Intensity of Acute Postoperative Pain (APP)
Pain intensity assessed using the Numeric Rating Scale (NRS). The scale ranges from 0 to 10, where 0 indicates "no pain" and 10 indicates the "worst imaginable pain". Lower scores indicate better pain control.
Time frame: 10 minutes, 60 minutes, 120 minutes, 6 hours, and 24 hours post-surgery
Total Need for Rescue Analgesia
The total cumulative dose of rescue pain medication administered to the patient when NRS scores exceed the acceptable threshold. Quantified and reported in Morphine Equivalent Doses (MED) in milligrams.
Time frame: Up to 24 hours post-surgery.
Patient Satisfaction and Quality of Recovery
Assessed using the Postoperative Quality of Recovery Scale (PQRS). This tool evaluates multiple domains of recovery (physiological, nociceptive, emotional, activities of daily living, and cognitive).
Time frame: Through hospital discharge, an average of 7 days post-surgery
Incidence of Postoperative complications
The number of participants experiencing any episode of nausea, vomiting, respiratory adverse events, ileus, that requires the administration of rescue antiemetic medication.
Time frame: Up to 24 hours post-surgery.
Plan to share: No
No publications or documents are linked to this record.
Started Mar 2025 (actual). Primary completion is estimated for Jul 2027, 28 months after the start.
How these figures are worked out, and which studies are left out of them.
This study is active, not recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Hospital Universitario La Fe