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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gabriele Baldini, Assistant Professor, McGill University Health Center
ClinicalTrials.gov Identifier:
NCT01477190
First received: November 16, 2011
Last updated: November 24, 2011
Last verified: November 2011
History of Changes
  Purpose

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).


Condition Intervention Phase
Colon Cancer
Inflammatory Bowel Diseases
Diverticulitis
 Drug: Spinal analgesia
Drug: Patient Control Analgesia (PCA) Morphine
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Spinal Analgesia for Colonic Resection Using an Enhanced Recovery After Surgery (ERAS) Program

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by McGill University Health Center:

Primary Outcome Measures:
  • postoperative pain [ Time Frame: daily during hospitalization up to 3 days after the operation ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • opioid consumption [ Time Frame: daily during hospitalization up to 3 days after the operation ] [ Designated as safety issue: No ]
  • opioid side effects [ Time Frame: daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days ] [ Designated as safety issue: Yes ]

Enrollment: 40
Study Start Date: October 2010
Study Completion Date: October 2011
Primary Completion Date: October 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Spinal group
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.
 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.
Other Name: Spinal block, intrathecal block
Active Comparator: PCA group
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.
 Drug: 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.
Other Name: Patient Control Analgesia Morphine.

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.

  Eligibility

Ages Eligible for Study:   18 Years to 90 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01477190

Locations
Canada, Quebec
Montreal General Hospital
Montreal, Quebec, Canada, H3G1A4
Sponsors and Collaborators
McGill University Health Center
Investigators
Study Director: Franco Carli, Professor McGill University Health Center
  More Information

No publications provided

Responsible Party: Gabriele Baldini, Assistant Professor, Dr, McGill University Health Center
ClinicalTrials.gov Identifier: NCT01477190     History of Changes
Other Study ID Numbers: GEN-06-023(2)
Study First Received: November 16, 2011
Last Updated: November 24, 2011
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Colonic Neoplasms
Diverticulitis
Inflammatory Bowel Diseases
Intestinal Diseases
Colorectal Neoplasms
Intestinal Neoplasms
Gastrointestinal Neoplasms
Digestive System Neoplasms
Neoplasms by Site
Neoplasms
Digestive System Diseases
Gastrointestinal Diseases
Colonic Diseases
 Gastroenteritis
Morphine
Analgesics, Opioid
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Central Nervous System Agents
Therapeutic Uses
Central Nervous System Depressants
Narcotics

ClinicalTrials.gov processed this record on May 16, 2013