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

University Health Network, Toronto

Status: Completed

Conditions: Low Back Pain

Treatments: Drug: Saline Placebo; Drug: Bupivicaine, Hydromorphone

Study type: Interventional

Funder types: Other

Identifiers

NCT00644111

UHN 07-0736-A

Details and patient eligibility

About

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.

Enrollment: 32 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Quadruple Blind

---

32 participants in 2 patient groups, including a placebo group

1

Placebo Comparator group

Description:

Control group receiving saline placebo through an epidural catheter

Treatment:

Drug: Saline Placebo

2

Active Comparator group

Description:

Experimental group receiving active medication through the epidural catheter

Treatment:

Drug: Bupivicaine, Hydromorphone