Multimodal Analgesia Versus Routine Care Pain Management

Spinal Stenosis Clinical Trial

— MMA  

Official title:

Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01861743
• Other study ID #: 13020402
• Status: Terminated
• Phase: N/A
• Start date: April 2013
• Est. completion date: December 2017

Study information

• Verified date: August 2018
• Source: Rush University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 42
• Est. completion date: December 2017
• Est. primary completion date: December 31, 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Degenerative Disc Disease Lumbar
• Intervertebral Disc Degeneration
• Lumbar Spondylolisthesis
• Spinal Stenosis
• Spondylolisthesis

Intervention

Other:
• Multimodal Analgesia
Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
• Patient controlled analgesia
Subjects will be treated with patient controlled narcotic analgesia for pain management.

Locations

Country	Name	City	State
United States	Rush University Medical Center-Orthopedic Spine	Chicago	Illinois

Sponsors (1)

Lead Sponsor	Collaborator
Rush University Medical Center

Country where clinical trial is conducted

United States, 

References & Publications (2)

Kim JC, Choi YS, Kim KN, Shim JK, Lee JY, Kwak YL. Effective dose of peri-operative oral pregabalin as an adjunct to multimodal analgesic regimen in lumbar spinal fusion surgery. Spine (Phila Pa 1976). 2011 Mar 15;36(6):428-33. doi: 10.1097/BRS.0b013e3181 — View Citation

Rajpal S, Gordon DB, Pellino TA, Strayer AL, Brost D, Trost GR, Zdeblick TA, Resnick DK. Comparison of perioperative oral multimodal analgesia versus IV PCA for spine surgery. J Spinal Disord Tech. 2010 Apr;23(2):139-45. doi: 10.1097/BSD.0b013e3181cf07ee. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Length of Stay		Post operatively (avg: 1-3 days)
Other	Discharge destination	Determine whether patients are discharged to home or to another facility (e.g. rehab, etc)	Post operatively (avg:1-3 days)
Other	Adverse events		Post operatively (avg: 1-3 days)
Other	Disease specific and General health outcome measures	Short form 36 and the Oswestry Disabilty Index	Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
Primary	Numeric pain scale	(a) While in the hospital, patients' pain is assessed by a nurse-driven protocol. Assessments are every four to six hours, within 60 minutes after receiving an intravenous pain medication and within 90 minutes of receiving an oral pain medication. This assessment includes rating subjective rating of ones pain on a verbal numeric rating scale (NRS) of 0-10. The maximum pain score for each post-operative day will be compared.	Patients will be followed post-operatively while in the hospital (Avg 1-3 days), and a 6 weeks, 3 months, 6 months, 1 year and 2 years.
Secondary	Patient satisfaction	At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management. (yes/no)	Post operatively (avg: 1-3 days)