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

McGill University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Colon Cancer; Inflammatory Bowel Diseases; Diverticulitis

Treatments: Drug: Patient Control Analgesia (PCA) Morphine; Drug: Spinal analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01477190

GEN-06-023(2)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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40 participants in 2 patient groups

Spinal group

Experimental group

Description:

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.

Treatment:

Drug: Spinal analgesia

PCA group

Active Comparator group

Description:

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.

Treatment:

Drug: Patient Control Analgesia (PCA) Morphine