Study to Find Optimal Dose of Local Spinal Anesthetic (Mepivacaine) Combined With Narcotic (Fentanyl) For Knee Surgery

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier:
NCT01701102
First received: January 4, 2012
Last updated: March 9, 2016
Last verified: March 2016
Results First Received: February 11, 2016  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Investigator);   Primary Purpose: Treatment
Condition: Arthroscopic Knee Surgery
Interventions: Procedure: Mepivacaine (24 mg) plus fentanyl
Procedure: Mepivacaine (27 mg) plus fentanyl
Procedure: Mepivacaine (30 mg) plus fentanyl
Procedure: Mepivacaine

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups
  Description
Mepivacaine 37.5 mg Mepivacaine (37.5 mg)
Mepivacaine 30 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (30 mg) and fentanyl (10 µg)
Mepivacaine 27 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (27 mg) and fentanyl (10 µg)
Mepivacaine 24 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 mg) and fentanyl (10 µg)

Participant Flow:   Overall Study
    Mepivacaine 37.5 mg     Mepivacaine 30 mg Plus Fentanyl 10 µg     Mepivacaine 27 mg Plus Fentanyl 10 µg     Mepivacaine 24 mg Plus Fentanyl 10 µg  
STARTED     22     6     10     18  
COMPLETED     22     6     10     18  
NOT COMPLETED     0     0     0     0  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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Reporting Groups
  Description
Mepivacaine 37.5 mg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Mepivacaine 30 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Mepivacaine 27 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Mepivacaine 24 mg Plus Fentanyl 10 µg Mepivacaine plus fentanyl: Mepivacaine (24 - 37.5 mg) and fentanyl (10 µg)
Total Total of all reporting groups

Baseline Measures
    Mepivacaine 37.5 mg     Mepivacaine 30 mg Plus Fentanyl 10 µg     Mepivacaine 27 mg Plus Fentanyl 10 µg     Mepivacaine 24 mg Plus Fentanyl 10 µg     Total  
Number of Participants  
[units: participants]
  22     6     10     18     56  
Age  
[units: years]
Mean (Full Range)
  41   (19 to 55)     50   (42 to 57)     46   (27 to 60)     45   (19 to 60)     44   (19 to 60)  
Gender  
[units: participants]
         
Female     12     3     2     5     22  
Male     10     3     8     13     34  
Body Mass Index  
[units: kg/(m^2)]
Mean (Standard Deviation)
  26.3  (3.8)     26.0  (4.3)     28.5  (5.6)     28.7  (4.8)     27.4  (4.6)  



  Outcome Measures

1.  Primary:   Time From Spinal Administration to Block Regression to the S1 Dermatome in Post-Anesthesia Care Unit (PACU)   [ Time Frame: Participants will be followed for the duration of their recovery after surgery in the post-anesthesia care unit (PACU), an expected average of 2-4 hours. ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
All Principal Investigators ARE employed by the organization sponsoring the study.


Results Point of Contact:  
Name/Title: Jennifer Cheng
Organization: Hospital for Special Surgery
phone: 212-774-7377
e-mail: chengj@hss.edu



Responsible Party: Hospital for Special Surgery, New York
ClinicalTrials.gov Identifier: NCT01701102     History of Changes
Other Study ID Numbers: 11140
Study First Received: January 4, 2012
Results First Received: February 11, 2016
Last Updated: March 9, 2016
Health Authority: United States: Institutional Review Board