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OpenTrials
Completed

NCT Number: NCT00644111

Post-operative Epidural Analgesia After Minimally Invasive Lumbar Decompression and Fusion

Minimally invasive (MIS) lumbar decompression and fusion is a new procedure that aims to reduce post-operative pain, opioid consumption and related side effects, and length of hospital stay. Current research demonstrates a modest improvement in these areas beginning on the third post-operative day. MIS fusion, however, incurs significant cost as the average time of the procedure is approximately one third greater (from 148 minutes to 191 on average). Epidural analgesia has clearly demonstrated benefits for conventional open laminectomy. In order to fully maximize the benefits of an MIS technique, early post-operative analgesia/pain must be improved. The aim of this study is to combine two techniques to ultimately improve patient outcomes and satisfaction. This will be a randomized trial involving 32 patients undergoing MIS decompression and fusion with half the study group receiving active epidural and IV-PCA and the other half receiving epidural placebo and IV-PCA.

The hypothesis is that epidural analgesia will reduce post-operative opioid consumption, improve pain scores, and decrease time to ambulation as well as discharge from hospital after MIS decompression and fusion.

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Key information

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Toronto Western Hospital, University Health Network

Toronto, Ontario, M5T 2S8, Canada

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • patients scheduled to undergo minimally invasive lumbar decompression and fusion at the Toronto Western Hospital
  • both genders
  • ASA I to III
  • BMI less than 35

Exclusion criteria

  • refuses treatment randomization
  • inability to give informed consent
  • language barrier
  • local anesthetic allergy
  • allergy to shellfish or eggs
  • bleeding diathesis
  • sickle cell disease or trait
  • pregnancy
  • drug addiction
  • psychiatric history
  • severe intercurrent illness (ASA IV or V)
  • patients requiring anesthesia of other surgical sites

Treatment and study plan

Bupivicaine, Hydromorphone

Drug

0.1% Bupivicaine with 0.015mg hydromorphone per mL at 6 mL per hour in Arm 2

Saline placebo

Drug

Saline placebo continuous epidural infusion of 6 mL per hour in Arm 1

Primary outcomes

  1. Reduction in opioid consumption in the first 48 hours post-operatively

    Time frame: 48 hours

Secondary outcomes

  1. Reduction in VRS pain scores

    Time frame: Duration of Admission

  2. Reduction in total opioid consumption

    Time frame: Duration of Admission

  3. Reduction in opioid related side effects

    Time frame: Duration of Admission

  4. Reduction in time to discharge

    Time frame: Duration of Admission

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Important dates

Study start
2008
Primary completion
2011
Study completion
2011
First posted
Mar 26, 2008
Registry last updated
Feb 13, 2013

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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