PainNCT00720330
Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain
A study testing ropivacaine and Lidocaine/Ketamine in people with Pain and Nausea, run by The Cleveland Clinic at 1 site in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 75 years, men only
- What is being tested?
- ropivacaine and Lidocaine/Ketamine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2008to Feb 2010
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 and less than 75 years
- Male
- Unilateral inguinal hernia scheduled for elective open repair
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Cleveland Clinic/Hillcrest Hospital
Mayfield Heights, Ohio, 44124
About this study
Official title: 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.
Read the detailed description
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
- Being tested
- ropivacaine, Lidocaine/Ketamine, placebo
- Keywords
- Inguinal Herniorrhaphy, Pain assessment, Outcomes
- Medical subject headings
- Pain, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ropivacaineDrug
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/KetamineDrug
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).
placeboOther
placebo
| Study group | Role | What they receive |
|---|---|---|
| Ropivacaine | 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 Receives: Drug: ropivacaine |
| Lidocaine/ketamine | 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. Receives: Drug: Lidocaine/Ketamine |
| Placebo | Placebo comparator | General anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Opioid Consumption in Oral Oxycodone Equivalents
The cumulative opioid consumption after surgery until the end of second postoperative day.
Measured: 2 days after surgery
Secondary outcomes (4)
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
The cumulative opioid consumption is calculated as fentanyl equivalent
Measured: From admission to the end of surgery
Time From the End of Surgery to Readiness for Hospital Discharge.
Measured: Until hospital discharge, assessed up to 6 months
Pain Scores on Numerical Rating Scale
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.
Measured: After surgery until the second postoperative mornings.
Postoperative Nausea
Number of patients who had postoperative nausea or vomiting were recorded.
Measured: After surgery until the second postoperative day.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jul 2008 (estimated)
- Study startJul 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Why it stopped: Enrollment challenges prohibited study progression.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by The Cleveland ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kenneth Cummings III, MD, MS, The Cleveland Clinic
- Investigators
- Kenneth Cummings, MD, Principal investigator, The Cleveland ClinicDaniel I Sessler, MD, Study chair, The Cleveland Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00720330
- Sponsor's protocol ID
- 08-385
- Status last verified
- Mar 2019
- First submitted
- 21 Jul 2008
- Last updated
- 12 Mar 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Thoracolumbar Paravertebral Block or Intravenous Lidocaine and Ketamine Versus Standard Care on Acute and Chronic Pain After Inguinal Herniorrhaphy
- ClinicalTrials.gov ID
- NCT00720330
- Acronym / sponsor ID
- 08-385
- Keywords
- Inguinal Herniorrhaphy, Pain assessment, Outcomes
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment challenges prohibited study progression.
- Enrolment
- 12 participants (actual)
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Study start
- Jul 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 22 Jul 2008 (estimated)
- Results
- Posted 19 May 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ropivacaine | Active comparator | Drug: ropivacaineParavertebral 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 |
| Lidocaine/ketamine | Active comparator | Drug: Lidocaine/KetamineParticipant 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 | Placebo comparator | Other: placeboGeneral anesthesia plus placebo. Placebo will be administered intravenously until 60 minutes after surgery |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 and less than 75 years
- Male
- Unilateral inguinal hernia scheduled for elective open repair
Key exclusion criteria (9 listed)
- Incarcerated hernia or urgent procedure
- Reoperation (recurrent hernia)
- Contraindication to regional anesthesia such as:
- Coagulopathy
- Infection at the site of needle insertion
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ropivacaine10 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 | Drug | Ropivacaine |
| Lidocaine/KetaminePatients 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). | Drug | Lidocaine/ketamine |
| placeboplacebo | Other | Placebo |
Primary outcome
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.
4 secondary outcomes
Pre- and Intra-operative Opioid Consumption in Fentanyl Equivalents
Time frame: From admission to the end of surgery
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.
Postoperative Nausea
Time frame: After surgery until the second postoperative day.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth Cummings, MD principal investigator
The Cleveland Clinic
Daniel I Sessler, MD study chair
The Cleveland Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ropivacaine and Lidocaine/Ketamine in people with Pain and Nausea, run by The Cleveland Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 May 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Postoperative Opioid Consumption in Oral Oxycodone Equivalents (time frame: 2 days after surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2019.