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

NCT01477190 | Completed Phase 1 DMC

• 1 other identifier: GEN-06-023(2)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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).

Conditions

Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Outcome Measures

Primary Outcomes (1)

• postoperative pain

  daily during hospitalization up to 3 days after the operation

Secondary Outcomes (2)

• 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

Study Arms (2)

Spinal group

EXPERIMENTAL

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

PCA group

ACTIVE COMPARATOR

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

Interventions

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.

Also known as: Spinal block, intrathecal block

Spinal group

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.

Also known as: Patient Control Analgesia Morphine.

PCA group

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• patients scheduled to undergo laparoscopic colonic resection

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G1A4, Canada

Location

MeSH Terms

Conditions

Colonic Neoplasms; Inflammatory Bowel Diseases; Diverticulitis

Interventions

Anesthesia, Spinal; Passive Cutaneous Anaphylaxis; Morphine

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Gastroenteritis; Diverticular Diseases

Intervention Hierarchy (Ancestors)

Anesthesia, Conduction; Anesthesia; Anesthesia and Analgesia; Skin Tests; Immunologic Tests; Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Immunologic Techniques; Antigen-Antibody Reactions; Immune System Phenomena; 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 Officials

• Franco Carli, Professor

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

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr

Study Record Dates

• First Submitted: November 16, 2011
• First Posted: November 22, 2011
• Study Start: October 1, 2010
• Primary Completion: October 1, 2011
• Study Completion: October 1, 2011
• Last Updated: November 28, 2011

Record last verified: 2011-11

Locations

CA (1)