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Trial record 60 of 69 for:    Famotidine

Analgesia After Total Knee Arthroplasty: Peri-Articular Injection Versus Epidural + Femoral Nerve Blockade (PAI vs FNB)

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ClinicalTrials.gov Identifier: NCT01335542
Recruitment Status : Completed
First Posted : April 14, 2011
Results First Posted : April 20, 2016
Last Update Posted : September 14, 2016
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Outcomes Assessor)
Condition Readiness to Discharge
Interventions Procedure: Peri-Articular Injection
Procedure: Epidural Pathway (PCEA+FNB)
Enrollment 91
Recruitment Details  
Pre-assignment Details One patient in the local infiltration group was deemed ineligible due to a rheumatoid arthritis. Only 90 patients were randomized to the study.
Arm/Group Title Epidural Pathway Local Infiltration
Hide Arm/Group Description meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
Period Title: Overall Study
Started 45 45
Completed 45 45
Not Completed 0 0
Arm/Group Title Epidural Pathway Local Infiltration Total
Hide Arm/Group Description meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN) Total of all reporting groups
Overall Number of Baseline Participants 45 45 90
Hide Baseline Analysis Population Description
One patient in the local infiltration group was deemed ineligible due to a rheumatoid arthritis. The remaining 90 patients were included in the baseline analysis population.
Age, Continuous  
Mean (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 45 participants 45 participants 90 participants
67
(50 to 84)
65
(49 to 81)
66
(49 to 82)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Female
29
  64.4%
29
  64.4%
58
  64.4%
Male
16
  35.6%
16
  35.6%
32
  35.6%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 45 participants 45 participants 90 participants
45 45 90
BMI  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 45 participants 45 participants 90 participants
Normal 3 2 5
Overweight 19 20 39
Obese 21 20 41
Morbidly Obese 2 3 5
1.Primary Outcome
Title The Primary Outcome is Time Until a Patient is "Ready for Discharge."
Hide Description

The primary outcome is time until a patient is "ready for discharge." Discharge criteria are:

  • PCA (if present) has been discontinued
  • Not experiencing moderate or severe nausea (within last 4 hours).
  • Solid food diet
  • Able to urinate (Foley catheter removed)
  • Pain: NRS <4.
  • Surgical wound dry
  • No acute medical problems
  • Physical Therapy Criteria

    • Independently transfer from supine to sit, from sitting to standing
    • Ambulate 40 ft. without assistance
    • Extension range of motion (< 10 degrees)
Time Frame Participants will be followed for the duration of their hospital stay, an expected average of 3 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Epidural Pathway Local Infiltration
Hide Arm/Group Description:
meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV
meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
Overall Number of Participants Analyzed 45 45
Mean (Inter-Quartile Range)
Unit of Measure: days
3.2
(1.8 to 7.0)
3.2
(1 to 14)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Epidural Pathway Local Infiltration
Hide Arm/Group Description meloxicam (7.5 or 15mg), extended release oxycodone (10mg or 20mg), dexamethasone (6mg), clonidine patch (100 mcg/24 hr) Anesthetic: Spinal with 0.5% bupivacaine, IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Post-operative analgesia:Prilosec (20mg), Meloxicam (7.5mg or 15 mg PO), extended release oxycodone (10mg or 20mg), Oxycodone (5mg q 3 hr PRN), Acetaminophen (1000mg), ketorolac 15mg IV meloxicam (7.5 or 15mg), dexamethasone (6mg) Anesthetic:: Combined Spinal-Epidural with 0.5% bupivacaine. IV sedation with midazolam, propofol Antiemetic: 20mg famotidine, 4mg ondansetron Postoperative pain management: hydromorphone/bupivacaine PCEA (4/4/10/20, initially). Meloxicam (7.5 or 15mg), Oxycodone/Acetaminophen (5/325 3hr PRN)
All-Cause Mortality
Epidural Pathway Local Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Epidural Pathway Local Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Epidural Pathway Local Infiltration
Affected / at Risk (%) Affected / at Risk (%)
Total   0/45 (0.00%)   0/45 (0.00%) 
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Name/Title: Dr. Jacques YaDeau
Organization: Hospital for Special Surgery
Phone: 2127742224
Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01335542     History of Changes
Other Study ID Numbers: 10002
First Submitted: April 8, 2011
First Posted: April 14, 2011
Results First Submitted: March 21, 2016
Results First Posted: April 20, 2016
Last Update Posted: September 14, 2016