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Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain

This study has been terminated.
(Enrollment challenges prohibited study progression.)
Sponsor:
Information provided by (Responsible Party):
Kenneth Cummings III, MD, MS, The Cleveland Clinic
ClinicalTrials.gov Identifier:
NCT00720330
First received: July 21, 2008
Last updated: April 14, 2017
Last verified: April 2017
Results First Received: April 14, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Care Provider, Investigator, Outcomes Assessor;   Primary Purpose: Treatment
Conditions: Pain
Nausea
Interventions: Drug: ropivacaine
Drug: Lidocaine/Ketamine
Other: placebo

  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
No text entered.

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
Ropivacaine

Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation

ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation

Lidocaine/Ketamine

Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.

Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).

Placebo

General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery

placebo: placebo


Participant Flow:   Overall Study
    Ropivacaine   Lidocaine/Ketamine   Placebo
STARTED   5   4   3 
COMPLETED   5   4   3 
NOT COMPLETED   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.
No text entered.

Reporting Groups
  Description
Ropivacaine

Paravertebral Group - A local anesthetic (ropivacaine) will be injected near the spine before surgery. Participants will also receive midazolam and fentanyl intravenously (through your vein) for sedation

ropivacaine: 10 ml 0.5% ropivacaine plus epinephrine will be injected at T11 and L1 as described above (20 ml total) using intravenous midazolam (1-2 mg) and fentanyl (0.5-1 mcg/kg) for sedation

Lidocaine/Ketamine

Participant will receive general anesthesia through the vein before surgery. Lidocaine and ketamine will be administered intravenously throughout surgery and for 60 minutes after surgery.

Lidocaine/Ketamine: Patients will receive a general anesthetic consisting of intravenous induction with lidocaine (1.5 mg/kg), propofol (1.5-2.5 mg/kg), ketamine (0.25 mg/kg), fentanyl (1 mcg/kg), and midazolam (1-2 mg).

Placebo

General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery

placebo: placebo

Total Total of all reporting groups

Baseline Measures
   Ropivacaine   Lidocaine/Ketamine   Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 5   4   3   12 
Age 
[Units: Years]
Mean (Standard Deviation)
 48  (12)   52  (10)   53  (13)   50  (11) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Male      5 100.0%      4 100.0%      3 100.0%      12 100.0% 
Race (NIH/OMB) 
[Units: Participants]
Count of Participants
       
American Indian or Alaska Native      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Asian      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Native Hawaiian or Other Pacific Islander      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Black or African American      0   0.0%      0   0.0%      1  33.3%      1   8.3% 
White      5 100.0%      4 100.0%      2  66.7%      11  91.7% 
More than one race      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Unknown or Not Reported      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Weight 
[Units: Kg]
Mean (Standard Deviation)
 90  (13)   77  (14)   101  (13)   88  (15) 
Height 
[Units: Cm]
Mean (Standard Deviation)
 176  (10)   183  (5)   179  (13)   179  (7) 


  Outcome Measures
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1.  Primary:   Postoperative Opioid Consumption in Oral Oxycodone Equivalents   [ Time Frame: 2 days after surgery ]

2.  Secondary:   Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents   [ Time Frame: From admission to the end of surgery ]

3.  Secondary:   Time From the End of Surgery to Readiness for Hospital Discharge.   [ Time Frame: Until hospital discharge, assessed up to 6 months ]

4.  Secondary:   Pain Scores on Numerical Rating Scale   [ Time Frame: After surgery until the second postoperative mornings. ]

5.  Secondary:   Postoperative Nausea   [ Time Frame: After surgery until the second postoperative day. ]


  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: Roberta Johnson
Organization: Cleveland Clinic
phone: 216-444-9950
e-mail: johnsor13@ccf.org



Responsible Party: Kenneth Cummings III, MD, MS, The Cleveland Clinic
ClinicalTrials.gov Identifier: NCT00720330     History of Changes
Other Study ID Numbers: 08-385
Study First Received: July 21, 2008
Results First Received: April 14, 2017
Last Updated: April 14, 2017