Multimodal Analgesia Versus Routine Care Pain Management

NCT01861743 | Terminated

• 1 other identifier: 13020402
• Study Type: interventional
• Target: 42
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Degenerative Disc Disease Lumbar; Spinal Stenosis; Lumbar Spondylolisthesis

Keywords

Multi-modal Pain Management; Lumbar fusion; misTLIF

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Patient satisfaction

  Post operatively (avg: 1-3 days)

Other Outcomes (4)

• Length of Stay

  Post operatively (avg: 1-3 days)

• Discharge destination

  Post operatively (avg:1-3 days)

• Adverse events

  Post operatively (avg: 1-3 days)

Study Arms (2)

Multimodal analgesia

EXPERIMENTAL

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.

Other: Multimodal Analgesia

Patient Controlled analgesia

ACTIVE COMPARATOR

Pain management using patient controlled narcotic analgesia.

Other: Patient controlled analgesia

Interventions

Multimodal Analgesia OTHER

Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.

Multimodal analgesia

Patient controlled analgesia OTHER

Subjects will be treated with patient controlled narcotic analgesia for pain management.

Patient Controlled analgesia

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rush University Medical Center: lead

Study Sites (1)

Rush University Medical Center-Orthopedic Spine

Chicago, Illinois, 60612, United States

Location

Related 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.0b013e3181d26708.

  PMID: 21372654 RESULT

• 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.

  PMID: 20375829 RESULT

MeSH Terms

Conditions

Spinal Stenosis; Spondylolisthesis

Interventions

Analgesia, Patient-Controlled

Condition Hierarchy (Ancestors)

Spinal Diseases; Bone Diseases; Musculoskeletal Diseases; Spondylolysis; Spondylosis

Intervention Hierarchy (Ancestors)

Analgesia; Anesthesia and Analgesia

Study Officials

• Frank M Phillips, MD

  Rush University Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 8, 2013
• First Posted: May 24, 2013
• Study Start: April 1, 2013
• Primary Completion: December 31, 2016
• Study Completion: December 1, 2017
• Last Updated: August 29, 2018

Record last verified: 2018-08

Locations

US (1)