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ACTIVE NOT RECRUITING
NCT07771049
PHASE1/PHASE2

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

Sponsor: Hospital Universitario La Fe

View on ClinicalTrials.gov

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. 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.

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

Key Details

Gender

All

Age Range

18 Years - 90 Years

Study Type

INTERVENTIONAL

Enrollment

200

Start Date

2025-03-15

Completion Date

2028-12

Last Updated

2026-08-18

Healthy Volunteers

No

Interventions

DRUG

Opioid-Free Anesthesia (OFA)

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.

DRUG

Opioid-Based Anesthesia (OBA)

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.

Locations (2)

Doctor Jose Molina Orosa

Arrecife, Spain

Royo Villanova

Zaragoza, Spain