Pain, PostoperativePhase 4NCT00330941
Intravenous Lidocaine and Acute Rehabilitation
A Phase 4 study testing lidocaine in people with Pain, Postoperative and Opioid Consumption, Postoperative, run by The Cleveland Clinic at 1 site in Belgium.
Trial summary
Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Pain, Postoperative, Opioid Consumption, Postoperative, Postoperative Fatigue
- What is being tested?
- lidocaine
- How many people
- 45 participants
- Where
- 1 siteBelgium
- Study dates
- Jan 2003to Dec 2004
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- ASA I-III
- non-malignant disease
Who cannot join
- greater than 70 years
- history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug)
- hepatic insufficiency
- psychiatric disorder
- steroid treatment
- chronic treatment with opioid
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization.
Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75% interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P<0.05 was considered statistically significant.
- Being tested
- lidocaine
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Sevoflurane consumption
Pain scores
abdominal comfort
fatigue scores
Secondary outcomes (3)
bowel function
hospital stay
endocrine and metabolic responses
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 May 2006 (estimated)
- Study startJan 2003
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pain, PostoperativeStudies 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 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 45 participants
Sponsor and investigators
- Lead sponsor
- The Cleveland Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- University of Liege
- Investigators
- Jean Joris, MD, PhD, Study director, Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00330941
- Sponsor's protocol ID
- Joris, Lidocaine Outcomes
- Status last verified
- Apr 2023
- First submitted
- 25 May 2006
- Last updated
- 13 Apr 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Intravenous Lidocaine Infusion Improves Outcome After Laparoscopic Colectomy
- ClinicalTrials.gov ID
- NCT00330941
- Acronym / sponsor ID
- Joris, Lidocaine Outcomes
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants
- Lead sponsor
- The Cleveland ClinicUniversity, hospital or other
- Collaborators
- University of Liege
- Study start
- Jan 2003
- Study completion
- Dec 2004
- First posted
- 29 May 2006 (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.
Background: Intravenous infusion of lidocaine may decrease postoperative pain and speed return of bowel function. The investigators therefore tested the hypothesis that including perioperative lidocaine infusion improves recovery from laparoscopic colectomy and shortens the duration of hospitalization.
Methods: Forty patients scheduled for laparoscopic colectomy were randomly allocated to receive intravenous lidocaine (bolus injection of 1.5 mg.kg-1 lidocaine at induction of anesthesia, then a continuous infusion of 2 mg.kg-1.h-1 intraoperatively and 1.33 mg.kg-1.h-1 for 24 h postoperatively) or an equal volume of saline. All patients received similar intensive postoperative rehabilitation. Postoperative pain scores, opioid consumption, and fatigue scores were measured. Times to first flatus, defecation, and hospital discharge were recorded. Postoperative endocrine (cortisol and catecholamines) and metabolic (leucocytes, C-reactive protein, and glucose) responses were measured for 48 h. Data (median [25%-75% interquartile range] Saline vs Lidocaine groups) were analyzed using Mann-Whitney tests. P<0.05 was considered statistically significant.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- ASA I-III
- non-malignant disease
Key exclusion criteria (6 listed)
- greater than 70 years
- history of gastro-duodenal peptic ulcer or renal failure (contraindications to the use of nonsteroidal anti-inflammatory drug)
- hepatic insufficiency
- psychiatric disorder
- steroid 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 |
|---|---|---|
| lidocaine | Drug | – |
Primary outcome
Sevoflurane consumption
Pain scores
abdominal comfort
fatigue scores
3 secondary outcomes
bowel function
hospital stay
endocrine and metabolic responses
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 13 Apr 2023.
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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.
Jean Joris, MD, PhD study director
Department of Anesthesia and Intensive Care Medicine, CHU de Liège, University of Liège, Belgium
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 lidocaine in people with Pain, Postoperative and Opioid Consumption, Postoperative, run by The Cleveland Clinic at 1 site in Belgium.
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 2 inclusion and 6 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 13 Apr 2023. 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 Belgium. 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?
Sevoflurane consumption. 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 13 Apr 2023.