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

NCT ID: NCT01477190

Last Updated: 2011-11-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-10-31

Study Completion Date

2011-10-31

Brief Summary

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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

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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.

Conditions

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Colon Cancer Inflammatory Bowel Diseases Diverticulitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

Spinal analgesia

Intervention Type 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.

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.

Group Type ACTIVE_COMPARATOR

Patient Control Analgesia (PCA) Morphine

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type DRUG

Other Intervention Names

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Spinal block, intrathecal block Patient Control Analgesia Morphine.

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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

OTHER

Sponsor Role lead

Responsible Party

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Gabriele Baldini, Assistant Professor

Dr

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Franco Carli, Professor

Role: STUDY_DIRECTOR

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

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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GEN-06-023(2)

Identifier Type: -

Identifier Source: org_study_id