Epidural Analgesia Versus IV Analgesia in Lumbar Spine Fusions
10 januari 2017 uppdaterad av: Duke University
A Comparison of Epidural Analgesia With Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
- Protocol Title - A Comparison of Epidural Analgesia with Standard Care Following Lumbar Spinal Fusion: A Prospective Randomized Study
- Purpose of the Study - This prospective randomized study will enroll 200 patients undergoing elective Lumbar Spinal Fusion at Duke University Hospital. The primary objective is to determine the effect of epidural analgesia, as compared with standard care, on post-operative analgesia.
Hypothesis:
The investigators hypothesize that patients undergoing Lumbar Spinal Fusion surgery with epidural catheter placement will have superior post-operative analgesia compared to patients undergoing standard care.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Studietyp
Interventionell
Inskrivning (Faktisk)
17
Fas
- Fas 3
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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North Carolina
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Durham, North Carolina, Förenta staterna, 27710
- Duke University Hospital
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
18 år och äldre (Vuxen, Äldre vuxen)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
Inclusion Criteria:
- Adult patients who are scheduled for elective Transforaminal Lumbar Interbody Fusion surgery
Exclusion Criteria:
- Baseline cognitive deficits sufficient to make objective pain self-assessments unreliable in the estimation of the Study Investigators.
- Inability to follow directions or comprehend the English language.
- Females who are pregnant as determined by positive pregnancy test on or before the day of surgery.
- Prisoners.
- Patient refusal to provide informed consent.
- Allergy to amide local anesthetics (lidocaine, bupivacaine, ropivacaine).
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: Intravenous opioids
This is the standard of care method for post-operative analgesia following lumbar spine fusion surgery.
Participants randomly assigned to this arm will receive Intravenous Patient-Controlled Analgesia (IVPCA) with dilaudid (or other opioid) for post-operative pain control.
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Patients in this arm will receive intravenous patient-controlled opioid analgesia (Dilaudid).
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Experimentell: Epidural Catheter
The intervention to be tested in this study against standard intravenous opioids is infusion of local anesthetic and dilaudid via epidural catheter for post-operative pain control in patients undergoing lumbar spine fusion surgery.
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Placement of an epidural catheter to administer local anesthetic and opioid (dilaudid) to the epidural space will be studied as compared to use of intravenous opioid (dilaudid) for pain control following lumbar spine fusion surgery.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Post-operative Pain as Assessed by Visual Analogue Scale (VAS)
Tidsram: Postoperative day 1
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The VAS scale ranges from 0 to 100 mm with the lower score indicating less pain and the higher score indicating greater pain.
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Postoperative day 1
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Patient Satisfaction With Perioperative Analgesia
Tidsram: Post-operative Day 1
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Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
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Post-operative Day 1
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Patient Satisfaction With Perioperative Analgesia
Tidsram: 6-Week Follow up Visit
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Patients will be assessed for satisfaction with their peri-operative analgesia in the recovery room and each day of their epidural infusion or intravenous opioid infusion by the Acute Pain Service, and at their surgical follow-up visit.
Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
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6-Week Follow up Visit
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Patient Satisfaction With Overall Care
Tidsram: 6-Week Follow up Visit
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Likert scale ranges from 1 to 5 (1=very satisfied and 5=Very Dissatisfied).
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6-Week Follow up Visit
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Number of Participants With Events of Special Interest
Tidsram: Post-operative Day 30
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Patients will be assessed for development of a deep vein thrombosis after surgery, and surgical site infection.
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Post-operative Day 30
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Number of Participants With Adverse Events Related to the Study
Tidsram: 6-week Follow up Visit
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Patients will be assessed in the recovery room and each day of their epidural or intravenous opioid infusions, and at their surgical follow-up visit.
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6-week Follow up Visit
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Total Post-operative Opioid Consumption
Tidsram: during hospitalization (approximately 3-8 days)
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during hospitalization (approximately 3-8 days)
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Number of Participants Experiencing Delirium
Tidsram: Post-operative Day 1
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Post-operative Day 1
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Number of Participants Experiencing Delirium
Tidsram: Post-operative Day 2
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Post-operative Day 2
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Number of Participants Experiencing Delirium
Tidsram: Post-operative Day 3
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Post-operative Day 3
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Number of Participants Readmitted to Hospital Within 30 Days of Surgery
Tidsram: Post-operative Day 30
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Post-operative Day 30
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Length of Hospital Stay
Tidsram: during hospitalization (approximately 3-8 days)
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during hospitalization (approximately 3-8 days)
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Wound Infection Rates
Tidsram: during hospitalization (approximately 3-8 days)
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during hospitalization (approximately 3-8 days)
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Sponsor
Utredare
- Huvudutredare: Erin L Manning, MD/PhD, Duke University Hospital Department of Anesthesiology
- Huvudutredare: Carlos Bagley, MD, Duke University Hospital Department of Neurosurgery
Publikationer och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna publikationer
- Block BM, Liu SS, Rowlingson AJ, Cowan AR, Cowan JA Jr, Wu CL. Efficacy of postoperative epidural analgesia: a meta-analysis. JAMA. 2003 Nov 12;290(18):2455-63. doi: 10.1001/jama.290.18.2455.
- Yukawa Y, Kato F, Ito K, Terashima T, Horie Y. A prospective randomized study of preemptive analgesia for postoperative pain in the patients undergoing posterior lumbar interbody fusion: continuous subcutaneous morphine, continuous epidural morphine, and diclofenac sodium. Spine (Phila Pa 1976). 2005 Nov 1;30(21):2357-61. doi: 10.1097/01.brs.0000184377.31427.fa.
- Cohen BE, Hartman MB, Wade JT, Miller JS, Gilbert R, Chapman TM. Postoperative pain control after lumbar spine fusion. Patient-controlled analgesia versus continuous epidural analgesia. Spine (Phila Pa 1976). 1997 Aug 15;22(16):1892-6; discussion 1896-7. doi: 10.1097/00007632-199708150-00016.
- Abrishamkar S, Eshraghi N, Feizi A, Talakoub R, Rafiei A, Rahmani P. Analgesic effects of ketamine infusion on postoperative pain after fusion and instrumentation of the lumbar spine: a prospective randomized clinical trial. Med Arh. 2012;66(2):107-10. doi: 10.5455/medarh.2012.66.107-110.
- Sekar C, Rajasekaran S, Kannan R, Reddy S, Shetty TA, Pithwa YK. Preemptive analgesia for postoperative pain relief in lumbosacral spine surgeries: a randomized controlled trial. Spine J. 2004 May-Jun;4(3):261-4. doi: 10.1016/j.spinee.2003.11.009.
- Sucato DJ, Duey-Holtz A, Elerson E, Safavi F. Postoperative analgesia following surgical correction for adolescent idiopathic scoliosis: a comparison of continuous epidural analgesia and patient-controlled analgesia. Spine (Phila Pa 1976). 2005 Jan 15;30(2):211-7. doi: 10.1097/01.brs.0000150832.53604.64.
- Parker SL, Lerner J, McGirt MJ. Effect of minimally invasive technique on return to work and narcotic use following transforaminal lumbar inter-body fusion: a review. Prof Case Manag. 2012 Sep-Oct;17(5):229-35. doi: 10.1097/NCM.0b013e3182529c05.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
1 oktober 2013
Primärt slutförande (Faktisk)
1 september 2015
Avslutad studie (Faktisk)
1 september 2015
Studieregistreringsdatum
Först inskickad
3 januari 2013
Först inskickad som uppfyllde QC-kriterierna
12 november 2013
Första postat (Uppskatta)
19 november 2013
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
23 februari 2017
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
10 januari 2017
Senast verifierad
1 januari 2017
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- Pro00041252
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