Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
|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.
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|