PainPhase 3NCT00789620
Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery
A Phase 3 study testing lidocaine in people with Pain and Fatigue, run by Insel Gruppe AG, University Hospital Bern at 1 site in Switzerland.
Trial summary
Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. Read more about this study
- Who is it for?
- Any age
- What is being tested?
- lidocaine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 76 participants
- Where
- 1 siteSwitzerland
- Study dates
- Nov 2008to Mar 2011
- Phase
- Phase 3
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Written informed consent
- ASA 1 to 3
- Laparoscopic transperitoneal urological surgery
Who cannot join
- Liver insufficiency
- Steroid therapy
- Chronic opioid therapy
- Allergy to lidocaine
- Pre-existing disorder of the gastrointestinal tract
- AV-block II-III, sinusbradycardia, heart insufficiency, long QT-syndrome
- Pregnancy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-blind, Phase III Study
Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects from pain relieving medication minimized with a potential for a more rapid postoperative recovery and less complications. IV application of lidocaine should de-crease the duration of bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay (primary outcome). We expect that the intraoperative inflammatory response can significantly be reduced.
Read the detailed description
Effective perioperative analgesia is the key to postoperative rehabilitation. It has been suggested that a decrease in postoperative pain and opioid use ameliorates the return of normal bowel function after general surgery. Conventional analgesic treatment involves the use of intravenous, oral and transdermal formulations of drugs. Repetitive administration is required for sustained pain relief. Common side effects (postoperative nausea and vomiting, postoperative ileus) of these analgesics may have a detrimental effect on postoperative recovery and led to a prolonged hospital stay. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that by far exceeds both the duration of the infusion and the half-life of the drug thus reducing concomitant analgesic medication can be reduced and its side effects enabling a more rapid postoperative recovery with less complications. Lidocaine is a commonly used local anesthetic and an antiarrythmic agent. It has been shown to preserve neuroelectric function in animal experiments. Intraoperative administration of lidocaine in a standard antiarrythmic dose has been shown to decrease the occurrence of cognitive dysfunction in the early postoperative period after coronary artery bypass surgery. Lidocaine can induce a significant re-duction of several components of chronic pain in patients with poststroke or spinal cord injury related pain. Sodium channel blockers (e.g. lidocaine) are approved for intravenous administration in the treat-ment of neuropathic pain states. In addition lidocaine has anti-inflammatory properties and preclinical studies have suggested antihyperalgesic effects on the peripheral and central nervous system. Lidocaine decreases the minimum alveolar concentration (MAC) of inhaled anesthetics and has been used clinically to reduce the requirements for other anesthetic drugs. IV application of lidocaine is said to decrease the duration of bowel dysfunction and postoperative pain intensity.
We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay. We expect that the intraoperative inflammatory response can significantly be reduced.
- Being tested
- lidocaine, placebo
- Keywords
- intravenous lidocaine, laparoscopic urological surgery, hospital stay, pain, fatigue, length of stay
- Medical subject headings
- Pain, Fatigue
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h
placeboDrug
Bolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | Lidocaine 1% administrated as a bolus of 1.5 mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24 h Receives: Drug: lidocaine |
| 2 | Placebo comparator | NaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hospital stay
Measured: end of hospitalisation
Secondary outcomes (5)
change in pain score
Measured: 2 and 4 h postop and 3*/d on day 1 and 2
changes in fatigue score
Measured: 2 and 4 h postop and 3*/d on day 1 and 2
PONV
Measured: 2 and 4 h postop and 3*/d on day 1 and 2
time to first episode of flatus and defecation
Measured: 2 and 4 h postop and 3*/d on day 1 and 2
changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)
Measured: preoperatively and on day 1 and 2 in the morning
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Nov 2008 (estimated)
- Study startNov 2008
- Primary completionMar 2011
- Study completionMar 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for PainStudies of the same condition, open and under way.
- More trials run by Insel Gruppe AG, University Hospital BernThe 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Insel Gruppe AG, University Hospital Bern
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Y Wüthrich, MD, Principal investigator, Dep. of Anesthesiology and pain service, Bern University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00789620
- Sponsor's protocol ID
- KEK_155_08
- Status last verified
- Mar 2011
- First submitted
- 11 Nov 2008
- Last updated
- 24 Mar 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Wuethrich PY, Romero J, Burkhard FC, Curatolo M. No benefit from perioperative intravenous lidocaine in laparoscopic renal surgery: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2012 Nov;29(11):537-43. doi: 10.1097/EJA.0b013e328356bad6.
PubMed 22907609
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Intravenous Lidocaine on Transperitoneal Laparoscopic Urological Surgery: A Prospective, Randomised, Placebo Controlled, Double-blind, Phase III Study
- ClinicalTrials.gov ID
- NCT00789620
- Acronym / sponsor ID
- KEK_155_08
- Keywords
- intravenous lidocaine, laparoscopic urological surgery, hospital stay, pain, fatigue, length of stay
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- Insel Gruppe AG, University Hospital BernUniversity, hospital or other
- Study start
- Nov 2008
- Primary completion
- Mar 2011 (actual)
- Study completion
- Mar 2011 (actual)
- First posted
- 13 Nov 2008 (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.
Effective perioperative analgesia is the key to postoperative rehabilitation. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that far exceeds both the duration of infusion and the half-life of the drug. When pain relief is provided, concomitant anal-gesic medication can be reduced, side effects from pain relieving medication minimized with a potential for a more rapid postoperative recovery and less complications. IV application of lidocaine should de-crease the duration of bowel dysfunction. We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay (primary outcome). We expect that the intraoperative inflammatory response can significantly be reduced.
Detailed description
Effective perioperative analgesia is the key to postoperative rehabilitation. It has been suggested that a decrease in postoperative pain and opioid use ameliorates the return of normal bowel function after general surgery. Conventional analgesic treatment involves the use of intravenous, oral and transdermal formulations of drugs. Repetitive administration is required for sustained pain relief. Common side effects (postoperative nausea and vomiting, postoperative ileus) of these analgesics may have a detrimental effect on postoperative recovery and led to a prolonged hospital stay. An intriguing body of evidence suggests that short-term administration of intravenous lidocaine may produce pain relief that by far exceeds both the duration of the infusion and the half-life of the drug thus reducing concomitant analgesic medication can be reduced and its side effects enabling a more rapid postoperative recovery with less complications. Lidocaine is a commonly used local anesthetic and an antiarrythmic agent. It has been shown to preserve neuroelectric function in animal experiments. Intraoperative administration of lidocaine in a standard antiarrythmic dose has been shown to decrease the occurrence of cognitive dysfunction in the early postoperative period after coronary artery bypass surgery. Lidocaine can induce a significant re-duction of several components of chronic pain in patients with poststroke or spinal cord injury related pain. Sodium channel blockers (e.g. lidocaine) are approved for intravenous administration in the treat-ment of neuropathic pain states. In addition lidocaine has anti-inflammatory properties and preclinical studies have suggested antihyperalgesic effects on the peripheral and central nervous system. Lidocaine decreases the minimum alveolar concentration (MAC) of inhaled anesthetics and has been used clinically to reduce the requirements for other anesthetic drugs. IV application of lidocaine is said to decrease the duration of bowel dysfunction and postoperative pain intensity.
We hypothesise that i.v. application of lidocaine in a standard antiarrythmic dose can significantly improve acute rehabilitation after laparoscopic urological surgery and so shorten the hospital stay. We expect that the intraoperative inflammatory response can significantly be reduced.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Active comparator | Drug: lidocaineLidocaine 1% administrated as a bolus of 1.5 mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24 h |
| 2 | Placebo comparator | Drug: placeboNaCl 0.9% as a bolus 1.5mg/kg, then intraoperative 2mg/kg/h and postoperative 1.3mg/kg/h during 24h |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Written informed consent
- ASA 1 to 3
- Laparoscopic transperitoneal urological surgery
Key exclusion criteria (7 listed)
- Liver insufficiency
- Steroid therapy
- Chronic opioid therapy
- Allergy to lidocaine
- Pre-existing disorder of the gastrointestinal tract
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 |
|---|---|---|
| lidocaine1.5 mg/kg as Bolus intraoperative: 2 mg/kg/h postoperative: 1.3mg/kg/h during 24h | Drug | 1 |
| placeboBolus 0.15 ml/kg NaCl 0.9% NaCl 0.2 ml/kg/h Perfusor NaCl 0.9% 0.13 ml/kg/h Perfusor | Drug | 2 |
Primary outcome
Hospital stay
Time frame: end of hospitalisation
5 secondary outcomes
change in pain score
Time frame: 2 and 4 h postop and 3*/d on day 1 and 2
changes in fatigue score
Time frame: 2 and 4 h postop and 3*/d on day 1 and 2
PONV
Time frame: 2 and 4 h postop and 3*/d on day 1 and 2
time to first episode of flatus and defecation
Time frame: 2 and 4 h postop and 3*/d on day 1 and 2
changes in metabolic and inflammatory responses (cortisol, glc, CRP and procalcitonin)
Time frame: preoperatively and on day 1 and 2 in the morning
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 24 Mar 2011.
- Derived from this study: PubMed 22907609Wuethrich PY, Romero J, Burkhard FC, Curatolo M. No benefit from perioperative intravenous lidocaine in laparoscopic renal surgery: a randomised, placebo-controlled study. Eur J Anaesthesiol. 2012 Nov;29(11):537-43. doi: 10.1097/EJA.0b013e328356bad6.
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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.
Patrick Y Wüthrich, MD principal investigator
Dep. of Anesthesiology and pain service, Bern University Hospital
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 Pain and Fatigue, run by Insel Gruppe AG, University Hospital Bern 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 3 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 24 Mar 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.
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?
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?
Hospital stay (time frame: end of hospitalisation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00789620, which also lists 1 linked publication.
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 24 Mar 2011.