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NCT Number: NCT01477190

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

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).

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Diverticular Diseases Diverticulitis Gastroenteritis Gastrointestinal Diseases Gastrointestinal Neoplasms Inflammatory Bowel Diseases Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Spinal analgesia

Drug

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 names: Spinal block, intrathecal block

Patient Control Analgesia (PCA) Morphine

Drug

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 names: Patient Control Analgesia Morphine.

Primary outcomes

  1. postoperative pain

    Time frame: daily during hospitalization up to 3 days after the operation

Secondary outcomes

  1. opioid consumption

    Time frame: daily during hospitalization up to 3 days after the operation

  2. opioid side effects

    Time frame: daily during hospitalization, participants will be followed for the duration of hospital stay, an expected average of 3 days

Sponsors and collaborators

Lead sponsor

McGill University Health Centre/Research Institute of the McGill University Health Centre

Other

Registry information

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Nov 22, 2011
Registry last updated
Nov 28, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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