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- Klinische proef NCT01861743
Multimodal Analgesia Versus Routine Care Pain Management (MMA)
Multimodal Analgesia Versus Routine Care Pain Management for Minimally Invasive Spine Surgery: A Prospective Randomized Study
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
We hypothesize patients undergoing spinal fusion who receive peri-operative MMA will have:
- decreased post-operative pain compared to patients receiving usual care for pain management.
- shorter hospital LOS compared to patients receiving usual care pain management.
- fewer analgesic-related post-operative complications (urinary retention, ileus, etc) compared to patients receiving usual care pain management.
- improved physical functioning at the time of hospital discharge compared to patients receiving usual care pain management.
- 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.
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Illinois
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Chicago, Illinois, Verenigde Staten, 60612
- Rush University Medical Center-Orthopedic Spine
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
- Oudere volwassene
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
---|---|
Experimenteel: 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.
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Subjects are given medications preop, intraop and postop that implement a multi-modal approach to managing pain.
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Actieve vergelijker: Patient Controlled analgesia
Pain management using patient controlled narcotic analgesia.
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Subjects will be treated with patient controlled narcotic analgesia for pain management.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Numeric pain scale
Tijdsspanne: 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.
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(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.
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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.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Patient satisfaction
Tijdsspanne: Post operatively (avg: 1-3 days)
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At each pain assessment (minimum every 4 hours), partients are asked if they are satisfied with their pain management.
(yes/no)
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Post operatively (avg: 1-3 days)
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Andere uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
---|---|---|
Length of Stay
Tijdsspanne: Post operatively (avg: 1-3 days)
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Post operatively (avg: 1-3 days)
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Discharge destination
Tijdsspanne: Post operatively (avg:1-3 days)
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Determine whether patients are discharged to home or to another facility (e.g.
rehab, etc)
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Post operatively (avg:1-3 days)
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Adverse events
Tijdsspanne: Post operatively (avg: 1-3 days)
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Post operatively (avg: 1-3 days)
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Disease specific and General health outcome measures
Tijdsspanne: Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
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Short form 36 and the Oswestry Disabilty Index
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Pre operatively (within 1 month of date of surgery) and Post operatively (6 weeks, 3months, 6 months, 1 year and 2 years)
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Frank M Phillips, MD, Rush University Medical Center
Publicaties en nuttige links
Algemene publicaties
- 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.
- 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.
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 13020402
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
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