| July 21, 2008 |
| September 17, 2009 |
| July 2008 |
| July 2010 (final data collection date for primary outcome measure) |
| Postoperative analgesic consumption in oral oxycodone equivalents [ Time Frame: 3 and 6 months post-operatively ] [ Designated as safety issue: No ] |
| Same as current |
| Complete list of historical versions of study NCT00720330 on ClinicalTrials.gov Archive Site |
- Pre and intraoperative analgesic consumption in fentanyl equivalents [ Time Frame: 3 and 6 months post-operatively ] [ Designated as safety issue: No ]
- Time from end of surgery to readiness for hospital discharge. [ Time Frame: number of days to hospital discharge ] [ Designated as safety issue: No ]
- Verbal response pain scores [ Time Frame: PACU admission and discharge,first and second postoperative mornings. ] [ Designated as safety issue: No ]
- Incidence of postoperative nausea [ Time Frame: Day 1 and day 2 post-operatively ] [ Designated as safety issue: No ]
|
| Same as current |
| |
| Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain |
| The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy |
The investigators are conducting this study to find out if intravenous (injected through the vein) infusion of lidocaine and ketamine administered with general anesthesia is as effective as a paravertebral block in lessening pain after surgery and that both of these techniques are superior to general anesthesia alone in reducing pain immediately after surgery and in the long-term. |
Participants will be randomized into one of three study groups; Group 1 - Paravertebral Group - ropivacaine is injected near the spine before surgery. Midazolam and fentanyl are administered intravenously for sedation. Group 2 - Lidocaine/Ketamine - General anesthesia with lidocaine and ketamine administered intravenously throughout your surgery and for 60 minutes after surgery. Group 3 - General Anesthesia Alone. General anesthesia with placebo administered intravenously throughout surgery and for 60 minutes after surgery. All participants will rate their pain on a scale from 0 to 10 after surgery and on days 1 and 2 after surgery. Participants are called 3 and 6 months after surgery for pain and quality of life assessments |
| |
| Interventional |
| Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Active Control, Parallel Assignment, Efficacy Study |
|
|
- Drug: ropivacaine
- Drug: Lidocaine/Ketamine
- Other: placebo
|
- Active Comparator: 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
- Active Comparator: 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.
- Placebo Comparator: General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery
|
| |
| |
| Recruiting |
| 486 |
| October 2010 |
| July 2010 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Age greater than 18 and less than 75 years
- Unilateral inguinal hernia scheduled for elective open repair
Exclusion Criteria:
- Incarcerated hernia or urgent procedure
- Reoperation (recurrent hernia)
- Contraindication to regional anesthesia such as:
- Coagulopathy
- Infection at the site of needle insertion
- Pre-existing chronic pain (at any site) requiring treatment
- Contraindication to any study medication (local anesthetic or ketamine)
- History of significant Axis I psychiatric disease (major depressive disorder,bipolar disorder, schizophrenia, etc.)
- Significant hepatic (ALT or AST > 2 times normal) or renal (serum creatinine > 2 mg/dl) impairment
|
| Both |
| 18 Years to 75 Years |
| No |
|
|
| United States |
| |
| NCT00720330 |
| Kenneth Cummings, MD, Cleveland Clinic |
| 08-385 |
| Outcomes Research Consortium |
|
| Principal Investigator: |
Kenneth Cummings, MD |
Cleveland Clinic |
|
| Study Chair: |
Daniel I Sessler, MD |
Cleveland Clinic |
|
|
| Outcomes Research Consortium |
| September 2009 |