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

Phase 1

Completed

• Conditions: Colon Cancer; Diverticulitis; Inflammatory Bowel Diseases
• Interventions: Drug: Spinal analgesia; Drug: Patient Control Analgesia (PCA) Morphine

• Registration Number: NCT01477190
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief 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).

Detailed 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.

Study Timeline

• Study Start: 2010-10
• Primary Completion: 2011-10
• Study Completion: 2011-10
• Status Verified: 2011-11
• Study First Submitted: 2011-11-16
• Study First Submitted QC: 2011-11-18
• Study First Posted: 2011-11-22
• Last Update Submitted: 2011-11-24
• Last Update Posted: 2011-11-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Spinal group	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.
PCA group	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.

Primary Outcome Measures

Name	Time	Method
postoperative pain	daily during hospitalization up to 3 days after the operation

Secondary Outcome Measures

Name	Time	Method
opioid consumption	daily during hospitalization up to 3 days after the operation
opioid side effects	daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada