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

NCT07771049 | Active Not Recruiting Phase 1

• 1 other identifier: OFA-CRC-2025
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 2

Brief 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

Keywords

Opioid-Free Anesthesia; Multimodal Analgesia; Laparoscopic Colorectal Surgery; Opioid Consumption; Enhanced Recovery After Surgery; Postoperative Complications

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Up to 24 hours post-surgery.

Secondary Outcomes (2)

• Patient Satisfaction and Quality of Recovery

  Through hospital discharge, an average of 7 days post-surgery

• Incidence of Postoperative complications

  Up to 24 hours post-surgery.

Study Arms (2)

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.

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.

Drug: Opioid-Based Anesthesia (OBA)

Interventions

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 Free Anesthesia

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.

Opioid Based Anesthesia

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Hospital Universitario La Fe: lead
• Hospital Universitario Royo Villanova: collaborator
• Hospital Universitario Doctor José Molina Orosa: collaborator

Study Sites (2)

Doctor Jose Molina Orosa

Arrecife, Spain

Location

Royo Villanova

Zaragoza, Spain

Location

MeSH Terms

Conditions

Agnosia; Postoperative Complications

Condition Hierarchy (Ancestors)

Perceptual Disorders; Neurobehavioral Manifestations; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Pathologic Processes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: single blinded
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator and Attending Anesthesiologist

Model Details: Study Design Study Type: Interventional Primary Purpose: Prevention Intervention Model: Parallel Assignment Masking: Single Blind (Participant) Allocation: Randomized

Study Record Dates

• First Submitted: August 10, 2026
• First Posted: August 18, 2026
• Study Start: March 15, 2025
• Primary Completion (Estimated): July 20, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: August 18, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)