Multimodal Analgesia Versus Routine Care Pain Management (MMA)

Rush

Status: Terminated

Conditions: Lumbar Spondylolisthesis; Spinal Stenosis; Degenerative Disc Disease Lumbar

Treatments: Other: Multimodal Analgesia; Other: Patient controlled analgesia

Study type: Interventional

Funder types: Other

Identifiers

NCT01861743

13020402

Details and patient eligibility

About

Most patients undergoing surgery experience significant post-operative pain. Inadequate peri-operative pain management may decrease post-operative mobilization and increase length of hospitalization. Additionally, poorly managed acute post-operative pain analgesia is associated with an increased risk of developing chronic pain and delayed wound healing.

Lumbar spine surgery is particularly painful, often requiring a multi-day hospitalization. The most common post-operative analgesia used in spine surgery is narcotic medication delivered via an intravenous patient controlled analgesia (IV PCA).

A multimodal peri-operative pain management protocol for spine surgery has the potential to not only decrease pain but also to improve recovery, decrease narcotic consumption, decrease length of stay in the hospital and reduce both direct and indirect hospital costs.

The purpose of this study is to determine if post-operative pain and rate of recovery are improved in patients undergoing spine surgery using MMA compared to usual analgesic care.

Full description

We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:

1. decreased post-operative pain compared to patients receiving usual care for pain management.
2. shorter hospital LOS compared to patients receiving usual care pain management.
3. fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
4. improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
5. better short and long term outcomes. Subjects will be randomized to MMA (Group 1) or usual care (Group 2). The unit of randomization will be a week (Monday through Sunday). Each week will randomly be assigned to MMA or usual care. Subjects who are hospitalized into a consecutive week will continue with the pain regimen they were assigned upon hospitalization.

Enrollment: 42 patients

Sex: All

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Patients undergoing single level MIS-TLIF
• Patients able to provide informed consent

Exclusion criteria

• Allergies or other contraindications to medicines in the protocol
• Current liver disease with documented liver function test abnormality
• Current renal disese with documented glomerular filtration rate (GFR) < 60 mL/min/1.73m2
• Baseline (pre-operative) opioid use greater than 30 mg of morphine equivalents/day
• Active alcohol dependence
• Active illicit drug dependence

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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42 participants in 2 patient groups

Multimodal analgesia

Experimental group

Description:

multiple analgesic medications utilized in a synergistic manner to control pain while minimizing side-effects of individual drugs due to decreased doses. This includes pre-operative patient education, intra-operative pain management and post-operative pain protocols.

Treatment:

Other: Multimodal Analgesia

Patient Controlled analgesia

Active Comparator group

Description:

Pain management using patient controlled narcotic analgesia.

Treatment:

Other: Patient controlled analgesia