Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

Colon Cancer Clinical Trial

Official title:

Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01477190
• Other study ID #: GEN-06-023(2)
• Status: Completed
• Phase: Phase 1/Phase 2
• First received: November 16, 2011
• Last updated: November 24, 2011
• Start date: October 2010
• Est. completion date: October 2011

Study information

• Verified date: November 2011
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial Summary

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the Enhanced Recovery After Surgery (ERAS) program.

Twenty patients will receive spinal analgesia and twenty patients will receive only Patient Control Analgesia (PCA).

Description:

This is a blinded randomized controlled trial in patients undergoing laparoscopic colon surgery. The aim of this study is to assess whether spinal analgesia with a mixture of bupivacaine and morphine provides better pain relief than systemic morphine in a group of patients undergoing colonic resection and using the ERAS program.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 2011
• Est. primary completion date: October 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 90 Years

Eligibility

Inclusion Criteria:

• patients scheduled to undergo laparoscopic colonic resection

Exclusion Criteria:

• patients who have trouble to understand, read or communicate either in French or in English

• dementia

• patients suffering from severe physical disability (arthritis, neuromuscular dysfunction, stroke, paraplegia) or inability to walk or conduct daily activity

• patients suffering from severe cardiac or respiratory disease (status ASA IV)

• patients suffering from metastatic carcinoma

• patients who have a history of chemoradiation within the six months preceding surgery

• morbid obesity

• contraindication to spinal analgesia

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Colon Cancer
• Diverticulitis
• Inflammatory Bowel Diseases

Intervention

Drug:
• Spinal analgesia
isobaric bupivacaine 0.5% 10 mg together with preservative-free morphine was injected. The dose of morphine was based on patient's age, with 200 µg in patients aged = 75 years and 150 µg in patients aged > 75 years.
• Patient Control Analgesia (PCA) Morphine
PCA Morphine is set to the patient for 48 hours postoperative. 2 mg. of morphine is given to a patient as much as patient requires, maximum at every 7 minutes.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
McGill University Health Center

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	postoperative pain		daily during hospitalization up to 3 days after the operation	No
Secondary	opioid consumption		daily during hospitalization up to 3 days after the operation	No
Secondary	opioid side effects		daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days	Yes