Bariatric Surgical PainPhase 3NCT01944098
Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients
A Phase 3 study testing Lidocaine in people with Bariatric Surgical Pain, run by University of South Florida at 1 site in United States.
Trial summary
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bariatric Surgical Pain
- What is being tested?
- Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2013to Sep 2014
- Phase
- Phase 3
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients between the ages of 18-65 years old
- BMI ≥ 40 kg/m2, ≤ 60 kg/m2
- Undergoing a primary laparoscopic RYGB by Dr. Murr
- Agree to be followed 24 hours postoperatively
- Normal K+ and Mg++ serum levels
Who cannot join
- BMI less than 40 kg/m2, > 60 kg/m2
- Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
- Allergy to lidocaine
- Allergy to hydromorphone or ketorolac
- Allergy to corn or amide anesthetics
- Use of (thioridizine)
Show all 13Show fewer
- Pregnancy
- Abnormalities of ALT or AST
- Intra-operative diagnosis of cirrhosis or portal hypertension
- Intraoperative complications per surgeon
- Intraoperative extensive adhesions per surgeon
- Chronic pain syndrome and chronic use of narcotics
- Severe back pain secondary to degenerative joint disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
- Conditions
- Bariatric Surgical Pain
- Being tested
- Lidocaine, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LidocaineDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Experimental | Intraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr Receives: Drug: Lidocaine |
| Placebo | Active comparator | Intraoperative continuous placebo infusion of dextrose at 2mg/kg/hr Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Measured: 6 hours post-surgery
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Measured: 12 hours post-surgery
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Measured: 18 hours post-surgery
Postoperative Pain
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Measured: 24 hours post-surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2013 (estimated)
- Study startAug 2013
- Primary completionJul 2014
- Study completionSep 2014
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 Bariatric Surgical PainStudies of the same condition, open and under way.
- More trials run by University of South FloridaThe 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of South Florida
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Karlnoski, PhD, Study director, Florida Gulf-to-Bay Anesthesiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01944098
- Sponsor's protocol ID
- Pro00002417
- Status last verified
- Dec 2015
- First submitted
- 12 Aug 2013
- Last updated
- 26 Oct 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Systemic Intraoperative Lidocaine Infusion for Postoperative Pain Management in Obese Patients: A Randomized, Placebo-Controlled Pilot Study
- ClinicalTrials.gov ID
- NCT01944098
- Acronym / sponsor ID
- Pro00002417
- Conditions
- Bariatric Surgical Pain
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of South FloridaUniversity, hospital or other
- Study start
- Aug 2013
- Primary completion
- Jul 2014 (actual)
- Study completion
- Sep 2014 (actual)
- First posted
- 17 Sep 2013 (estimated)
- Results
- Posted 26 Oct 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The primary objective is to assess the feasibility and safety of administering continuous intraoperative lidocaine infusions in adult patients undergoing laparoscopic Roux en Y Gastric Bypass (RYGB). The secondary objective is to determine if lidocaine administration versus placebo (dextrose administration) (initiated at the time of anesthesia induction and continued until extubation) will reduce postoperative narcotic requirements.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Experimental | Drug: LidocaineIntraoperative continuous IV infusion of Lidocaine at 2mg/kg/hr |
| Placebo | Active comparator | Drug: PlaceboIntraoperative continuous placebo infusion of dextrose at 2mg/kg/hr |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Adult patients between the ages of 18-65 years old
- BMI ≥ 40 kg/m2, ≤ 60 kg/m2
- Undergoing a primary laparoscopic RYGB by Dr. Murr
- Agree to be followed 24 hours postoperatively
- Normal K+ and Mg++ serum levels
Key exclusion criteria (13 listed)
- BMI less than 40 kg/m2, > 60 kg/m2
- Laparoscopic RYGB surgery performed by a surgeon other than Dr. Murr
- Allergy to lidocaine
- Allergy to hydromorphone or ketorolac
- Allergy to corn or amide anesthetics
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 |
|---|---|---|
| Lidocaine | Drug | Lidocaine |
| Placebo | Drug | Placebo |
Primary outcome
Postoperative Pain
Time frame: 6 hours post-surgery
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Postoperative Pain
Time frame: 12 hours post-surgery
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Postoperative Pain
Time frame: 18 hours post-surgery
Analysis of patient outcome will involve a series of visual analogue scale (VAS, 0 cm as no pain - 10 cm as maximum pain) pain evaluations during mobilization, coughing, and resting
Postoperative Pain
Time frame: 24 hours post-surgery
Analysis of patient outcome will involve a series of visual analogue scale pain evaluations during mobilization, coughing, and resting. VAS, 0 cm as no pain - 10 cm as maximum pain
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2017.
- 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.
Rachel Karlnoski, PhD study director
Florida Gulf-to-Bay Anesthesiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lidocaine in people with Bariatric Surgical Pain, run by University of South Florida 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 5 inclusion and 13 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: finished, as of the sponsor's last update on 26 Oct 2017. 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Oct 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 Pain (time frame: 6 hours post-surgery). The study lists 4 primary outcomes in all. 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 26 Oct 2017.