Epidural Versus Patient-controlled Analgesia for Reduction in Long-term Mortality Following Colorectal Cancer Surgery

NCT01318161 | Terminated Phase 3 DMC

• 1 other identifier: 2010/415-31
• Study Type: interventional
• Target: 221
• Locations: 1 country
• Sites: 2

Brief Summary

Colorectal cancer is one of the most common cancers in the industrialized world (12% of all cancers). In Sweden, 6000 new cases of colorectal cancer are reported each year, and almost half of these cases result in death. Several recently published retrospective studies show that regional anaesthesia (RA) can reduce cancer-related mortality following surgical treatment of colorectal, breast and prostate cancers and malignant melanoma. If these results are true, then the choice of perioperative pain management is as beneficial, or even better, than the current oncological therapies. This theory needs to be investigated in a prospective, randomized and controlled trail.

Conditions

Colorectal Cancer; Pain; Other Complications

Keywords

Epidural analgesia; Patient controlled analgesia; Colorectal cancer; Morbidity; Mortality

Outcome Measures

Primary Outcomes (1)

• Long-term (up to 5 yrs) all-cause mortality

  Cancer specific as well as all-cause mortality would be recorded.

  7 years from start of enrollment

Secondary Outcomes (1)

• Cancer recurrence detected by MRI; perioperative complications

  7 years following start of enrollment

Other Outcomes (2)

• Inflammation

  0-5 days

• Postoperative pain and early recovery

  0 - 7 days postoperatively

Study Arms (2)

Epidural anesthesia and analgesia

EXPERIMENTAL

Drug: Ropivacaine + opioid epidurally

Patient controlled analgesia

ACTIVE COMPARATOR

Drug: Morphine

Interventions

Ropivacaine + opioid epidurally DRUG

Epidural analgesia with local anesthetic + opioid

Epidural anesthesia and analgesia

Morphine DRUG

Morphine via PCA pump

Patient controlled analgesia

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ASA status 1-3
• Age group 40-80 years old
• Undergoing elective surgery for colorectal cancer

You may not qualify if:

• All contraindications to epidural analgesia
• Chronic opiate medication/drug abuse
• Allergy to morphine

Sponsors & Collaborators

• Örebro University, Sweden: lead
• University Hospital, Linkoeping: collaborator

Study Sites (2)

University Hospital

Linköping, 581 85, Sweden

Location

University Hospital

Örebro, 701 85, Sweden

Location

MeSH Terms

Conditions

Colorectal Neoplasms; Pain

Interventions

Ropivacaine; Morphine

Condition Hierarchy (Ancestors)

Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Rectal Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Anilides; Amides; Organic Chemicals; Aniline Compounds; Amines; Morphine Derivatives; Morphinans; Opiate Alkaloids; Alkaloids; Heterocyclic Compounds; Heterocyclic Compounds, Bridged-Ring; Heterocyclic Compounds, 4 or More Rings; Heterocyclic Compounds, Fused-Ring; Phenanthrenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: March 17, 2011
• First Posted: March 18, 2011
• Study Start: March 1, 2011
• Primary Completion: December 1, 2020
• Study Completion: January 1, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Locations

SE (2)