Multimodal Analgesia Versus Routine Care Pain Management

NCT ID: NCT01861743

Last Updated: 2018-08-29

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 42 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-04-30
• Study Completion Date: 2017-12-31

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.

Detailed 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.

Conditions

Degenerative Disc Disease Lumbar; Spinal Stenosis; Lumbar Spondylolisthesis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Multimodal analgesia

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.

Group Type: EXPERIMENTAL

Multimodal Analgesia

Intervention Type: OTHER

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

Patient Controlled analgesia

Pain management using patient controlled narcotic analgesia.

Group Type: ACTIVE_COMPARATOR

Patient controlled analgesia

Intervention Type: OTHER

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

Interventions

Multimodal Analgesia

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

Intervention Type: OTHER

Patient controlled analgesia

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

Intervention Type: OTHER

Eligibility Criteria

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

• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rush University Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Frank M. Phillips, MD

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Frank M Phillips, MD

Role: PRINCIPAL_INVESTIGATOR

Rush University Medical Center

Locations

Rush University Medical Center-Orthopedic Spine

Chicago, Illinois, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 21372654 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20375829 (View on PubMed)

Other Identifiers

13020402

Identifier Type: -

Identifier Source: org_study_id