Postoperative PainNCT01439399
Analgesic Efficacy of Intravenous Lidocaine and/or Ketamine
A study testing Lidocaine,, Ketamine and association ketamine-lidocaine in people with Postoperative Pain, run by University of Lausanne Hospitals at 1 site in Switzerland.
Trial summary
The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery. Read more about this study
- Who is it for?
- Ages 20 to 75 years
- Conditions the study is for
- Postoperative Pain
- What is being tested?
- Lidocaine,, Ketamine and association ketamine-lidocaine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2005to Jul 2007
- Phase
- Interventional
- 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 20 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- abdominal surgery by laparotomy
Who cannot join
- laparoscopy
- history of chronic pain
- opioid self-administration
- psychiatric disorders
- difficulties with communication
- renal or hepatic dysfunction
- ASA physical status > 3
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Center and University
Lausanne, Canton of Vaud, CH-1011
About this study
Official title: Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study
The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.
Read the detailed description
Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.
- Conditions
- Postoperative Pain
- Being tested
- Lidocaine,, Ketamine, association ketamine-lidocaine, Placebo
- Keywords
- postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption
- Medical subject headings
- Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lidocaine,Drug
Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative.
KetamineDrug
Ketamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h.
association ketamine-lidocaineDrug
Ketamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours.
PlaceboDrug
The control group (C) received an equal volume of saline 0.9 % during 48 h.
| Study group | Role | What they receive |
|---|---|---|
| Lidocaine | Active comparator | Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours Receives: Drug: Lidocaine, |
| Ketamine | Active comparator | Intravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours Receives: Drug: Ketamine |
| Ketamine-Lidocaine | Active comparator | Intravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours. Receives: Drug: association ketamine-lidocaine |
| Saline 0,9% | Placebo comparator | Control group Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cumulative morphine consumption
Cumulative morphine consumption over 48 hours postoperatively
Measured: 48 hours
Secondary outcomes (3)
Pain scores
Pain scores at rest and movement
Measured: 48 hours
Mechanical hyperalgesia
Mechanical hyperalgesia using pressure algometry
Measured: 48 hours
Occurrence of side effects
Occurrence of side effects: sedation, nausea, vomiting, itching, nightmares
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Sep 2011 (estimated)
- Study startDec 2005
- Primary completionJul 2007
- Study completionJul 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Postoperative PainStudies of the same condition, open and under way.
- 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
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joray Florence, University of Lausanne Hospitals
- Investigators
- Christian Kern, Study director, University of Lausanne Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01439399
- Sponsor's protocol ID
- KL-48h
- Other IDs
- 179/05
- Status last verified
- Sep 2011
- First submitted
- 20 Sep 2011
- Last updated
- 23 Sep 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Analgesic Efficacy of Intravenous Perfusion of Lidocaine, Ketamine or a Combination After Laparotomy in a Placebo-controlled, Randomized, Double-blind Prospective Study
- ClinicalTrials.gov ID
- NCT01439399
- Acronym / sponsor ID
- KL-48h
- Conditions
- Postoperative Pain
- Keywords
- postoperative pain, postoperative care, intravenous lidocaine, intravenous ketamine, morphine consumption
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- Dec 2005
- Primary completion
- Jul 2007 (actual)
- Study completion
- Jul 2007 (actual)
- First posted
- 23 Sep 2011 (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.
The aim of the present study is to evaluate the analgesic benefit of intravenous lidocaine and ketamine in the perioperative period of abdominal surgery.
Detailed description
Optimal postoperative pain management facilitates rehabilitation immediately after abdominal surgery. Multiple studies have demonstrated that successful postoperative analgesia also reduces perioperative complications and improves patient comfort, thereby providing many benefits for the patient. In acute postoperative pain management intravenous lidocaine and/or ketamine have been advocated because of their morphine-sparing effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Lidocaine | Active comparator | Drug: Lidocaine,Intravenous lidocaine administered preoperatively (anesthesia induction) and postoperatively during 48 hours |
| Ketamine | Active comparator | Drug: KetamineIntravenous ketamine administered preoperatively (anesthesia induction) and postoperatively during 48 hours |
| Ketamine-Lidocaine | Active comparator | Drug: association ketamine-lidocaineIntravenous association of ketamine and lidocaine administered preoperatively (at anesthesia induction) and postoperatively during 48 hours. |
| Saline 0,9% | Placebo comparator | Drug: PlaceboControl group |
Who may qualify
- Ages
- 20 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- abdominal surgery by laparotomy
Key exclusion criteria (7 listed)
- laparoscopy
- history of chronic pain
- opioid self-administration
- psychiatric disorders
- difficulties with communication
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,Lidocaine group received an IV bolus of 1.5 mg.kg-1 followed by a continuous infusion of 2 mg.kg-1.h-1 intraoperative and 1.33 mg.kg-1.h-1 for 48 h postoperative. | Drug | Lidocaine |
| KetamineKetamine group received a bolus of 0.5 mg.kg-1, then 0.25 mg.kg-1.h-1 followed by 0.1 mg.kg-1.h-1 for the first 24 h, then 0.05 mg.kg-1.h-1 for the next 24 h. | Drug | Ketamine |
| association ketamine-lidocaineKetamine-lidocaine group received a bolus of 1.5 mg.kg-1 of lidocaine and 0.5 mg.kg-1 of ketamine, a continuous infusion of 1.3 mg.kg-1.h-1 of lidocaine and 0.17 mg.kg-1.h-1 of ketamine was delivered followed by 0.9 mg.kg-1 of lidocaine with 0.08 mg.kg-1.h-1 of ketamine during 48 h, the dose of ketamine being reduced to 0.04 mg.kg-1.h-1 after the first 24 hours. | Drug | Ketamine-Lidocaine |
| PlaceboThe control group (C) received an equal volume of saline 0.9 % during 48 h. | Drug | Saline 0,9% |
Primary outcome
Cumulative morphine consumption
Time frame: 48 hours
Cumulative morphine consumption over 48 hours postoperatively
3 secondary outcomes
Pain scores
Time frame: 48 hours
Mechanical hyperalgesia
Time frame: 48 hours
Occurrence of side effects
Time frame: 48 hours
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 23 Sep 2011.
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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.
Christian Kern study director
University of Lausanne Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Lidocaine,, Ketamine and association ketamine-lidocaine in people with Postoperative Pain, run by University of Lausanne Hospitals at 1 site in Switzerland.
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 7 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 23 Sep 2011. 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 Switzerland. 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?
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?
Cumulative morphine consumption (time frame: 48 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 23 Sep 2011.