Postoperative Pain Management After Total Hip ArthroplastyPhase 1/2NCT01108562
Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion
A Phase 1/2 study testing Lidocaine and Normal Saline in people with Postoperative Pain Management After Total Hip Arthroplasty, run by Loma Linda University.
Trial summary
This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Postoperative Pain Management After Total Hip Arthroplasty
- What is being tested?
- Lidocaine and Normal Saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Feb 2008to Aug 2008
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking
Who cannot join
- Age > 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment
About this study
Official title: Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia: a Prospective Randomized, Double-blinded, Placebo-controlled Study
This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.
- Being tested
- Lidocaine, Normal Saline
- Keywords
- postoperative pain management
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
Patients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively.
Normal SalineOther
Patients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively.
| Study group | Role | What they receive |
|---|---|---|
| Control Group | Placebo comparator | Patients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline. Receives: Other: Normal Saline |
| Lidocaine Group | Experimental | Patients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion. Receives: Drug: Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia.
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2010 (estimated)
- Study startFeb 2008
- Primary completionAug 2008 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain Management After Total Hip ArthroplastyStudies of the same condition, open and under way.
- More trials run by Loma Linda UniversityThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Loma Linda University
- Sponsor type
- University, hospital or other
- Collaborators
- Charles Lee MD, Michelle Schlunt MD
- Responsible party
- Sponsor
- Investigators
- Michelle L Schlunt, MD, Principal investigator, Loma Linda University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01108562
- Sponsor's protocol ID
- 57366
- Status last verified
- Apr 2015
- First submitted
- 20 Apr 2010
- Last updated
- 6 Apr 2015
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 6 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Postoperative Pain After Total Hip Arthroplasty Using Intravenous Lidocaine Infusion in Combination With Patient Controlled Analgesia: a Prospective Randomized, Double-blinded, Placebo-controlled Study
- ClinicalTrials.gov ID
- NCT01108562
- Acronym / sponsor ID
- 57366
- Keywords
- postoperative pain management
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Loma Linda UniversityUniversity, hospital or other
- Collaborators
- Charles Lee MD, Michelle Schlunt MD
- Study start
- Feb 2008
- Primary completion
- Aug 2008 (estimated)
- First posted
- 22 Apr 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will focus on patients undergoing total hip arthroplasty and Loma Linda University Medical Center \& East Campus. These patients will be randomized to receive a low dose lidocaine infusion or placebo, in addition to the patient controlled analgesia pump. These groups will be compared to one another statistically to determine which group shows the safest and most satisfying pain control.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control Group | Placebo comparator | Other: Normal SalinePatients will receive a Dilaudid PCA in combination with a placebo infusion of normal saline. |
| Lidocaine Group | Experimental | Drug: LidocainePatients will be receive a Dilaudid PCA in combination with a continuous Lidocaine infusion. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult male or female undergoing a total hip arthroplasty Subject is American Society of Anesthesiologists physical status 1, 2, or 3 Subject has voluntarily signed and dated the informed consent document approved by the IRB Be English speaking
Key exclusion criteria (1 listed)
- Age > 80 years old or younger than 18 years old Congestive heart failure Hepatic insufficiency Neurological disorders Psychiatric disorders Steroid treatment No history of atrial fibrillation Chronic pain disorder with opioid treatment
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 |
|---|---|---|
| LidocainePatients in the experimental group will be receiving a Lidocaine infusion at 1.33 mg/kg/hr for 24 hours postoperatively. | Drug | Lidocaine Group |
| Normal SalinePatients in the control group will be receiving an infusion of normal saline for 24 hours postoperatively. | Other | Control Group |
Primary outcome
We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia.
Time frame: 24 hours
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Apr 2015.
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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.
Michelle L Schlunt, MD principal investigator
Loma Linda University Medical Center
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Lidocaine and Normal Saline in people with Postoperative Pain Management After Total Hip Arthroplasty, run by Loma Linda University.
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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 6 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
We propose to test the hypothesis that adding a low dose lidocaine infusion to patient controlled analgesia will lower the amount of opioids that these patients will receive, thereby improving patient safety while still providing adequate analgesia. (time frame: 24 hours). 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 6 Apr 2015.