Elective Surgical ProcedurePhase 2/3NCT00413127
Perioperative Protective Effects of Lidocaine
A Phase 2/3 study testing lidocaine and NaCl 0,9% in people with Elective Surgical Procedure and Colorectal Surgery, run by University Hospital Muenster at 3 sites in Germany.
Trial summary
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Elective Surgical Procedure, Colorectal Surgery
- What is being tested?
- lidocaine and NaCl 0,9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 78 participants
- Where
- 3 sitesGermany
- Study dates
- Sep 2007to Mar 2015
- Phase
- Phase 2/3
- 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 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective colorectal surgery
Who cannot join
- ASA > 3
- history of anti-inflammatory therapy
- history of inflammatory bowl diseases
- history of chronic pain treatment
Trial locations and contacts
3 sites in 1 country.
Germany3 sites
University Hospital Muenster
Münster, D-48129
St. Franziskushospital Muenster
Münster, D-48145
St. Marienhospital
Vechta, D-49377
About this study
Official title: Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery
- Conditions
- Elective Surgical Procedure, Colorectal Surgery
- Being tested
- lidocaine, NaCl 0,9%
- Keywords
- Systemic lidocaine, peridural lidocaine, perioperative analgesia, inflammation, Anesthesia
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
lidocaineDrug
administration of lidocaine intravenously or epidural or administration of placebo
NaCl 0,9%Drug
Administration of placebo i.v.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Lidocaine i.v Receives: Drug: lidocaine |
| 2 | Active comparator | intraoperatively lidocaine epidural postoperatively lidocaine i.v. Receives: Drug: lidocaine |
| 3 | Active comparator | intraoperatively lidocaine i.v. postoperatively lidocaine epidural Receives: Drug: lidocaine |
| 4 | Active comparator | lidocaine epidural Receives: Drug: lidocaine |
| 5 | Placebo comparator | placebo i.v. Receives: Drug: NaCl 0,9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
length of postoperative hospital stay
Measured: end of hospital stay
Secondary outcomes (7)
Hyperalgesia perioperative
Measured: postoperative day 2, 4, 8, end of hospital stay and follow-up
Cytokine levels perioperative
Measured: before surgery and 4 hours, 2 and 4 days after surgery
Bowel motility perioperative
Measured: days after surgery
Length of PACU stay
Measured: end of PACU stay
Cognitive function perioperatively
Measured: before surgery, one and four days after surgery, at end of hospital stay and follow-up
Incidence of wound healing disturbances
Measured: within 4 weeks after surgery
Postoperative Analgesia
Measured: until end of hospital stay
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Dec 2006 (estimated)
- Study startSep 2007
- Primary completionMar 2014
- Study completionMar 2015
Why it stopped: Less patients than expected for inclusion, therefore patient recruitment is to low
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Elective Surgical ProcedureStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 78 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Muenster
- Sponsor type
- University, hospital or other
- Collaborators
- International Anesthesia Research Society (IARS)
- Responsible party
- Sponsor
- Investigators
- K Hahnenkamp, MD, Study chair, Department of Anesthesiology and Intensive Care, University Hospital Muenster
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00413127
- Sponsor's protocol ID
- 06-AnIt-06
- Status last verified
- Jun 2015
- First submitted
- 18 Dec 2006
- Last updated
- 26 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
PubMed 16952918Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. doi: 10.1016/s0140-6736(77)90727-9.
PubMed 71604
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Perioperative Protective Effects of Lidocaine - Clinical Study on the Route and Timing of Administration
- ClinicalTrials.gov ID
- NCT00413127
- Acronym / sponsor ID
- 06-AnIt-06
- Conditions
- Elective Surgical Procedure, Colorectal Surgery
- Keywords
- Systemic lidocaine, peridural lidocaine, perioperative analgesia, inflammation, Anesthesia
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Less patients than expected for inclusion, therefore patient recruitment is to low
- Enrolment
- 78 participants (actual)
- Lead sponsor
- University Hospital MuensterUniversity, hospital or other
- Collaborators
- International Anesthesia Research Society (IARS)
- Study start
- Sep 2007
- Primary completion
- Mar 2014 (actual)
- Study completion
- Mar 2015 (actual)
- First posted
- 19 Dec 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.
The purpose of this study is to comparing effects of intravenously (IV) administered lidocaine to effects of epidurally (ED) administered lidocaine in patients undergoing elective colorectal surgery
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: lidocaineLidocaine i.v |
| 2 | Active comparator | Drug: lidocaineintraoperatively lidocaine epidural postoperatively lidocaine i.v. |
| 3 | Active comparator | Drug: lidocaineintraoperatively lidocaine i.v. postoperatively lidocaine epidural |
| 4 | Active comparator | Drug: lidocainelidocaine epidural |
| 5 | Placebo comparator | Drug: NaCl 0,9%placebo i.v. |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- elective colorectal surgery
Key exclusion criteria (4 listed)
- ASA > 3
- history of anti-inflammatory therapy
- history of inflammatory bowl diseases
- history of chronic pain 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 |
|---|---|---|
| lidocaineadministration of lidocaine intravenously or epidural or administration of placebo | Drug | 1, 2, 3, 4 |
| NaCl 0,9%Administration of placebo i.v. | Drug | 5 |
Primary outcome
length of postoperative hospital stay
Time frame: end of hospital stay
7 secondary outcomes
Hyperalgesia perioperative
Time frame: postoperative day 2, 4, 8, end of hospital stay and follow-up
Cytokine levels perioperative
Time frame: before surgery and 4 hours, 2 and 4 days after surgery
Bowel motility perioperative
Time frame: days after surgery
Length of PACU stay
Time frame: end of PACU stay
Cognitive function perioperatively
Time frame: before surgery, one and four days after surgery, at end of hospital stay and follow-up
Incidence of wound healing disturbances
Time frame: within 4 weeks after surgery
Postoperative Analgesia
Time frame: until end of hospital stay
Results and safety
The study was stopped early (reason given: Less patients than expected for inclusion, therefore patient recruitment is to low). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2015.
- Background: PubMed 16952918Kuo CP, Jao SW, Chen KM, Wong CS, Yeh CC, Sheen MJ, Wu CT. Comparison of the effects of thoracic epidural analgesia and i.v. infusion with lidocaine on cytokine response, postoperative pain and bowel function in patients undergoing colonic surgery. Br J Anaesth. 2006 Nov;97(5):640-6. doi: 10.1093/bja/ael217. Epub 2006 Sep 4.
- Background: PubMed 71604Cooke ED, Bowcock SA, Lloyd MJ, Pilcher MF. Intravenous lignocaine in prevention of deep venous thrombosis after elective hip surgery. Lancet. 1977 Oct 15;2(8042):797-9. doi: 10.1016/s0140-6736(77)90727-9.
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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.
K Hahnenkamp, MD study chair
Department of Anesthesiology and Intensive Care, University Hospital Muenster
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing lidocaine and NaCl 0,9% in people with Elective Surgical Procedure and Colorectal Surgery, run by University Hospital Muenster at 3 sites in Germany.
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 4 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: stopped early, as of the sponsor's last update on 26 Jun 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Germany. 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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 was stopped early (reason given: Less patients than expected for inclusion, therefore patient recruitment is to low). Results are not available in the source record.
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?
length of postoperative hospital stay (time frame: end of hospital stay). 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 NCT00413127, which also lists 2 linked publications.
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 Jun 2015.