Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
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|ClinicalTrials.gov Identifier: NCT00720330|
Recruitment Status : Terminated (Enrollment challenges prohibited study progression.)
First Posted : July 22, 2008
Results First Posted : May 19, 2017
Last Update Posted : May 19, 2017
|Condition or disease||Intervention/treatment||Phase|
|Pain Nausea||Drug: ropivacaine Drug: Lidocaine/Ketamine Other: placebo||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||12 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy|
|Study Start Date :||July 2008|
|Actual Primary Completion Date :||February 2010|
|Actual Study Completion Date :||February 2010|
Active Comparator: 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
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
Active Comparator: 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.
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 Comparator: Placebo
General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
- Postoperative Opioid Consumption in Oral Oxycodone Equivalents [ Time Frame: 2 days after surgery ]The cumulative opioid consumption after surgery until the end of second postoperative day.
- Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents [ Time Frame: From admission to the end of surgery ]The cumulative opioid consumption is calculated as fentanyl equivalent
- Time From the End of Surgery to Readiness for Hospital Discharge. [ Time Frame: Until hospital discharge, assessed up to 6 months ]
- Pain Scores on Numerical Rating Scale [ Time Frame: After surgery until the second postoperative mornings. ]Numerical Rating Scales is a measurement of pain ranging from 0 to 10 (11 point scale), where 0 is equal to no pain and 10 is equal to worst possible pain. Pain scores were measured in PACU, first and second postoperative mornings.
- Postoperative Nausea [ Time Frame: After surgery until the second postoperative day. ]Number of patients who had postoperative nausea or vomiting were recorded.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00720330
|United States, Ohio|
|Cleveland Clinic/Hillcrest Hospital|
|Mayfield Heights, Ohio, United States, 44124|
|Principal Investigator:||Kenneth Cummings, MD||The Cleveland Clinic|
|Study Chair:||Daniel I Sessler, MD||The Cleveland Clinic|