Active, Not RecruitingPhase 1Other

Opioid-Free Anesthesia in Colorectal Surgery, 2025 (OFA-CRC-2025)

Sponsored by Hospital Universitario La Fe

NCT ID
NCT07771049
Target Enrollment
200 participants
Start Date
2025-03-15
Est. Completion
2028-12

About This Study

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.

Conditions Studied

Pain ManagementColorectal SurgeryOpioid Free AnesthesiaPostoperative Complications

Interventions

  • Opioid-Free Anesthesia (OFA)
  • Opioid-Based Anesthesia (OBA)

Eligibility

Age:18 Years - 90 Years
Healthy Volunteers:No
View full eligibility criteria
Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* 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.

Study Locations (2)

Doctor Jose Molina Orosa
Arrecife, Spain
Royo Villanova
Zaragoza, Spain

This trial is not recruiting

This study is currently not accepting new participants.

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Data Source
ClinicalTrials.gov

Last updated from source