Pain ManagementPhase 1/2OFA-CRC-2025NCT07771049
Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)
A Phase 1/2 study testing Opioid-Free Anesthesia (OFA) and Opioid-Based Anesthesia (OBA) in people with Pain Management and Colorectal Surgery, run by Hospital Universitario La Fe at 2 sites in Spain.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Pain Management, Colorectal Surgery, Opioid Free Anesthesia
- What is being tested?
- Opioid-Free Anesthesia (OFA) and Opioid-Based Anesthesia (OBA)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 2 sitesSpain
- Study dates
- 15 Mar 2025to Dec 2028
- Phase
- Phase 1/2
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 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 to 90 years old of any sex.
- Diagnosed with colorectal cancer (any type and stage).
- Scheduled for elective laparoscopic colorectal surgery in the Lanzarote Health Area.
- Classified as American Society of Anesthesiologists (ASA) physical status I, II, or III.
- Ability to understand the study procedures and signed written informed consent.
Who cannot join
- Known allergy or hypersensitivity to any of the study drugs.
- Elevated intraocular pressure or history of intracranial lesions with a risk of elevated intracranial pressure.
- History of traumatic brain injury (TBI) or epileptic seizures.
- Severe psychiatric disease that may interfere with pain evaluation or outcome assessment.
- Hyperthyroidism or currently undergoing thyroid replacement therapy.
- Severe cardiac history, including congestive heart failure, severe coronary artery disease, poorly controlled tachyarrhythmias or bradyarrhythmias, or difficult-to-control arterial hypertension.
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- Baseline oxygen saturation (SpO2) < 90% on room air.
- Moderate or severe renal or hepatic insufficiency.
- Pathologies associated with hypersalivation or swallowing difficulties.
- Pregnancy or currently lactating.
Trial locations and contacts
2 sites in 1 country.
About this study
Official title: Prevention of Acute Postoperative Pain in Laparoscopic Colorectal Surgery: A Comparison Between Opioid-Free Anesthesia and Conventional Strategy as a Method of Intraoperative Analgesia
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.
Read the detailed description
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.
- Being tested
- Opioid-Free Anesthesia (OFA), Opioid-Based Anesthesia (OBA)
- Keywords
- Opioid-Free Anesthesia, Multimodal Analgesia, Laparoscopic Colorectal Surgery, Opioid Consumption, Enhanced Recovery After Surgery, Postoperative Complications
- Medical subject headings
- Agnosia, Postoperative Complications
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Opioid-Free Anesthesia (OFA)Drug
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.
Opioid-Based Anesthesia (OBA)Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| Opioid Free Anesthesia | Experimental | Intervention Type: Drug
Name: Opioid-Free Anesthesia Protocol
Description: Multimodal non-opioid intraoperative anesthesia including Dexmedetomidine, Lidocaine, Ketamine, Magnesium Sulfate, and Dexamethasone. Receives: Drug: Opioid-Free Anesthesia (OFA) |
| Opioid Based Anesthesia | Active comparator | 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. Receives: Drug: Opioid-Based Anesthesia (OBA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Up to 24 hours post-surgery.
Secondary outcomes (2)
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).
Measured: 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.
Measured: Up to 24 hours post-surgery.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start15 Mar 2025
- Primary completion20 Jul 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain ManagementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Study Design Study Type: Interventional Primary Purpose: Prevention Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Allocation: Randomized
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitario La Fe
- Sponsor type
- University, hospital or other
- Collaborators
- Hospital Universitario Royo Villanova, Hospital Universitario Doctor José Molina Orosa
- Responsible party
- Principal investigator, Daniel Pérez, Hospital Universitario Royo Villanova
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771049
- Sponsor's protocol ID
- OFA-CRC-2025
- Acronym
- OFA-CRC-2025
- Status last verified
- Aug 2026
- First submitted
- 10 Aug 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No