Postoperative Pain ManagementPhase 4NCT06725485
Low-Dose Lidocaine Infusion for Acute Pain Management Pilot Study
A Phase 4 study testing Low-Dose Lidocaine in people with Postoperative Pain Management, run by The Methodist Hospital Research Institute at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Postoperative Pain Management
- What is being tested?
- Low-Dose Lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 2 Jul 2021to 17 Jun 2024
- Phase
- Phase 4
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Males or females age > 18 years admitted to surgical ICU.
- Severe acute pain with pain scale > 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries.
- Women of childbearing age must have a negative urine/serum pregnancy test.
Who cannot join
- Regional anesthesia during surgery
- Heart failure with ejection fraction < 20%.
- Allergy to amide local anesthetics
- Neuraxial anesthesia during surgery
- Post-liver transplant patients
- Hemodynamically unstable patients on two or more vasopressors
Show all 12Show fewer
- Child-Pugh Class C or MELD >20
- Any investigational drug use within 30 days before enrollment
- Pregnant or lactating females
- Patients with chronic opioid-dependence
- Intubated and mechanically ventilated patients on intensive care unit analgo-sedation
- Subjects who do not agree to participate or may be non-compliant with study schedules or procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study
The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.
Read the detailed description
The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.
- Conditions
- Postoperative Pain Management
- Being tested
- Low-Dose Lidocaine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low-Dose LidocaineDrug
Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission.
| Study group | Role | What they receive |
|---|---|---|
| Low-Dose Lidocaine Infusion | Experimental | Low-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission. Receives: Drug: Low-Dose Lidocaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Opioid consumption on post-operative day 3
Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents
Measured: Post-operative day 3
Secondary outcomes (6)
Pain Scale at 72 Hours Post-Surgery
Patient numeric pain scale rating (0-10), with 0 being no pain and 10 being the worst pain possible
Measured: Post-operative day 3
Opioid-Free Days
The proportion of days post-surgery that the patient did not require opioid analgesia
Measured: Time of surgery through the end of post-operative day 3
Time Until Return in bowel function
Post-operative day when patient first has a bowel movement
Measured: Time of surgery through discharge, up to 30 days
Return to Oral Feeding
Post-operative day number when patient returns to oral feeding
Measured: Time of surgery through discharge, up to 30 days
Post-operative intensive care unit length of stay
Number of days between surgery and discharge from the intensive care unit after surgery
Measured: Time of surgery through intensive care unit discharge, up to 1 year
Post-operative hospital length of stay
Number of days between surgery and discharge from hospital after surgery
Measured: Time of surgery through hospital discharge, up to 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2024
- Study start2 Jul 2021
- Primary completion16 Feb 2024
- Study completion17 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative Pain ManagementStudies of the same condition, open and under way.
- More trials run by The Methodist Hospital Research InstituteThe 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 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- The Methodist Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hina Faisal, The Methodist Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06725485
- Sponsor's protocol ID
- PRO00027972
- Status last verified
- Dec 2024
- First submitted
- 19 Nov 2024
- Last updated
- 10 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-Dose Lidocaine Infusion for Acute Pain Management in the Surgical Intensive Care Unit - A Pilot Study
- ClinicalTrials.gov ID
- NCT06725485
- Acronym / sponsor ID
- PRO00027972
- Conditions
- Postoperative Pain Management
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- The Methodist Hospital Research InstituteUniversity, hospital or other
- Study start
- 2 Jul 2021 (actual)
- Primary completion
- 16 Feb 2024 (actual)
- Study completion
- 17 Jun 2024 (actual)
- First posted
- 10 Dec 2024 (actual)
- 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.
The purpose of this study is to evaluate the safety and efficacy of lidocaine infusion in acute pain management following open abdominal surgery, including opiate use after surgery and the incidence of postoperative nausea and vomiting, Ileus, length of stays (ICU/hospital), and improvement in patient satisfaction.
Detailed description
The management of acute pain remains challenging for the physicians, with many patients suffering from inadequate pain control following surgery. Evidence has shown that 90% of patients in the intensive care unit usually treated with opioids for pain. Poorly controlled pain and opioid-related adverse events have several negative consequences for critically ill patients during the postoperative period, including delay in functional recovery and hospital discharge, increased length of stay, development of chronic postsurgical pain, reduced patient satisfaction, and increased total healthcare cost. The reported incidence of postoperative Ileus varies with the procedure, ranging from 14.9% for large-bowel resection and 19.2% for small-bowel resection). Although many analgesic therapies are available, the high incidence of postoperative pain among patients indicates that there are still significant treatment challenges. Recently, there has been much interest in using low-dose lidocaine infusion for acute pain management in the operating room or/and PACU. Lidocaine is a drug with multiple effects, including anti-arrhythmic, local, topical, and injectable anesthetics. Lidocaine is also used for uncontrolled and chronic pain. However, this is an off-label use. Additionally, I.V. lidocaine is a potent anti-inflammatory, anti-hyperalgesic, and gastrointestinal pro-peristaltic drug. There is a lack of data on low dose lidocaine infusion for acute postoperative pain management in surgical critical care patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Low-Dose Lidocaine Infusion | Experimental | Drug: Low-Dose LidocaineLow-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Males or females age > 18 years admitted to surgical ICU.
- Severe acute pain with pain scale > 7, following open exploratory laparotomy for bowel, gall bladder, and pancreatic surgeries.
- Women of childbearing age must have a negative urine/serum pregnancy test.
Key exclusion criteria (12 listed)
- Regional anesthesia during surgery
- Heart failure with ejection fraction < 20%.
- Allergy to amide local anesthetics
- Neuraxial anesthesia during surgery
- Post-liver transplant patients
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 |
|---|---|---|
| Low-Dose LidocaineLow-dose lidocaine infusion 10-30 mcg/kg/min administered within 1 hour of ICU admission. | Drug | Low-Dose Lidocaine Infusion |
Primary outcome
Opioid consumption on post-operative day 3
Time frame: Post-operative day 3
Opioid consumption in a 24-hour period starting 3 days after surgery, measured in morphine milligram equivalents
6 secondary outcomes
Pain Scale at 72 Hours Post-Surgery
Time frame: Post-operative day 3
Opioid-Free Days
Time frame: Time of surgery through the end of post-operative day 3
Time Until Return in bowel function
Time frame: Time of surgery through discharge, up to 30 days
Return to Oral Feeding
Time frame: Time of surgery through discharge, up to 30 days
Post-operative intensive care unit length of stay
Time frame: Time of surgery through intensive care unit discharge, up to 1 year
Post-operative hospital length of stay
Time frame: Time of surgery through hospital discharge, up to 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Dec 2024.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Low-Dose Lidocaine in people with Postoperative Pain Management, run by The Methodist Hospital Research Institute 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 12 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 10 Dec 2024. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Opioid consumption on post-operative day 3 (time frame: Post-operative day 3). 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 10 Dec 2024.