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

NCT07771049 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 200

Last updated 2026-08-18

No results posted yet for this study

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.

Conditions

  • Pain Management
  • Colorectal Surgery
  • Opioid Free Anesthesia
  • Postoperative Complications

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.

Sponsors & Collaborators

  • Hospital Universitario Royo Villanova

    collaborator OTHER

  • Hospital Universitario Doctor José Molina Orosa

    collaborator OTHER

  • Hospital Universitario La Fe

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
90 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-03-15
Primary Completion
2027-07-20
Completion
2028-12-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07771049 on ClinicalTrials.gov