AnalgesiaPhase 4PPSAPACLNCT00860899
Postoperative Pain and SIRS After Preoperative Analgesia With Clonidine or Levobupivacaine
A Phase 4 study testing clonidine, levobupivacaine in people with Analgesia and Pain, run by University Hospital Dubrava at 1 site in Croatia.
Trial summary
The purpose of this study was to investigate hypothesis that preoperative administration of epidural clonidine will reduce postoperative pain and systemic inflammatory stress response better than epidural levobupivacaine. Read more about this study
- Who is it for?
- Ages 42 to 77 years
- Conditions the study is for
- Analgesia, Pain, Systemic Inflammatory Stress Response
- What is being tested?
- clonidine, levobupivacaine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 42 participants
- Where
- 1 siteCroatia
- Study dates
- Dec 2007to May 2009
- 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 42 to 77 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- colorectal resection surgery patients
- preoperative risk of anesthesia and operation, ASA (American Society of Anesthesiologists) physical status I or II
Who cannot join
- diabetes mellitus
- renal insufficiency
- liver insufficiency
- autoimmune disease
- corticosteroid and immunosuppressive use
- operation time exceeding six hours
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine
The purpose of this study was to investigate hypothesis that preoperative administration of epidural clonidine will reduce postoperative pain and systemic inflammatory stress response better than epidural levobupivacaine.
Read the detailed description
Investigations showed that upregulation of prostaglandin E2 and interleukin-6 at central sites is an important component of surgery induced inflammatory response in patients. Postoperative period is associated with an increased production of cytokines, which augment pain sensitivity. With adequate perioperative pain control it is possible to control central and peripheral inflammatory response to surgery, and influence on patient outcomes. Use of analgetics before the pain stimulus (preventive analgesia) prevent development of neuroplastic changes in central nervous system, and reduces pain. Clonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. According to recent experimental investigations clonidine lowers proinflammatory cytokine level, and prevents hypersensitization acting through adrenoreceptors alpha-2A.
Levobupivacaine is a long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency. When administered intraperitoneally or by local infiltration of operation site, levobupivacaine produced analgesia and reduction of proinflammatory cytokines. Investigations of epidural and intrathecal levobupivacaine provide evidence for improved postoperative analgesia with reduced analgesic consumption. But, it remains unknown if that analgesia is sufficient enough to blockade inflammatory stress response during perioperative time.We want to investigate and compare analgesic and immunomodulation efficacy of this two frequently used analgesics.
- Conditions
- Analgesia, Pain, Systemic Inflammatory Stress Response
- Being tested
- clonidine, levobupivacaine
- Keywords
- clonidine, levobupivacaine, preoperative analgesia, postoperative pain, systemic inflammatory stress response, epidural analgesia, Anesthetics, Local
- Medical subject headings
- Agnosia, Pain, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
clonidine, levobupivacaineDrug
Also called clonidine [Catapres®, Boehringer Ingelheim, Germany], levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]
One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine [Catapres®, Boehringer Ingelheim, Germany], 7 mL of 0.25% levobupivacaine [Chirocaine®, Abbott S.p.A., Italy] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy.
| Study group | Role | What they receive |
|---|---|---|
| clonidine | Active comparator | Clonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. Receives: Drug: clonidine, levobupivacaine |
| levobupivacaine | Active comparator | Levobupivacaine is long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency. Receives: Drug: clonidine, levobupivacaine |
What is being measured
The primary outcome is the main question the study is designed to answer.
postoperative pain level
Measured: 1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
Secondary outcomes (1)
systemic inflammatory stress response
Measured: 1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2009 (estimated)
- Study startDec 2007
- Primary completionOct 2008
- Study completionMay 2009
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 AnalgesiaStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 42 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital Dubrava
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jasminka Persec, MD, PhD, University Hospital Dubrava
- Investigators
- Jasminka Persec, MD PhD, Principal investigator, Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital DubravaZoran Persec, MD Msc, Study chair, Department of Urology, University Hospital DubravaIno Husedzinovic, Prof. MD PhD, Study director, Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00860899
- Sponsor's protocol ID
- 1860
- Other IDs
- 1861
- Acronym
- PPSAPACL
- Status last verified
- Nov 2011
- First submitted
- 10 Mar 2009
- Last updated
- 17 Nov 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C et al.Anesthesiology 104(3):403-410, 2006. 2. Katz J. Curr Opin Anaesthesiol 15(4):435-441, 2002. 3. Carr DB. Anesthesiology 85(6): 1498-1499, 1996. 4. Lavand'homme PM, Eisenach JC. Pain 105(1-2):247-254, 2003. 5. Nader ND, Ignatowski TA, Kurek CJ, Knight PR, Spengler RN. Anesth Analg 93(2):363-369, 2001. 6. Wu CT, Jao SW, Borel CO, Yeh CC, Li CY, Lu CH et al. Anesth Analg 99(2):502-509, 2004. 7. Novak-Jankovic V, Bovill JG, Ihan A, Osredkar J. Eur J Anaesthesiology 17(1):50-56, 2000. 8. Kim MH, Hahn TH. Anesth Analg 90(6):1441-1444, 2000. 9. Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG et al. Surg Endosc 19(11):1503-1506, 2005. 10. Meisner M, Brunkhorst FM, Reith HB, Schmidt J, Lestin HG et al. Clin Chem Lab Med 38(10):989-995, 2000. 11. Naeini AE, Montazerolghaem S. Saudi Med J 27(3):422-424, 2006. 12. Sarbinowski R, Arvidsson S, Tylman M, Oresland T, Bengtsson A. Acta Anaesthesiol Scand 49(2):191-196, 2005.
Study at a glance
From the registry record, last updated by the sponsor on 17 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postoperative Pain and Systemic Inflammatory Stress Response (SIRS) After Preoperative Analgesia With Clonidine or Levobupivacaine
- ClinicalTrials.gov ID
- NCT00860899
- Acronym / sponsor ID
- PPSAPACL / 1860
- Conditions
- Analgesia, Pain, Systemic Inflammatory Stress Response
- Keywords
- clonidine, levobupivacaine, preoperative analgesia, postoperative pain, systemic inflammatory stress response, epidural analgesia, Anesthetics, Local
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 42 participants (actual)
- Lead sponsor
- University Hospital DubravaUniversity, hospital or other
- Study start
- Dec 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- May 2009 (actual)
- First posted
- 12 Mar 2009 (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 was to investigate hypothesis that preoperative administration of epidural clonidine will reduce postoperative pain and systemic inflammatory stress response better than epidural levobupivacaine.
Detailed description
Investigations showed that upregulation of prostaglandin E2 and interleukin-6 at central sites is an important component of surgery induced inflammatory response in patients. Postoperative period is associated with an increased production of cytokines, which augment pain sensitivity. With adequate perioperative pain control it is possible to control central and peripheral inflammatory response to surgery, and influence on patient outcomes. Use of analgetics before the pain stimulus (preventive analgesia) prevent development of neuroplastic changes in central nervous system, and reduces pain. Clonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. According to recent experimental investigations clonidine lowers proinflammatory cytokine level, and prevents hypersensitization acting through adrenoreceptors alpha-2A.
Levobupivacaine is a long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency. When administered intraperitoneally or by local infiltration of operation site, levobupivacaine produced analgesia and reduction of proinflammatory cytokines. Investigations of epidural and intrathecal levobupivacaine provide evidence for improved postoperative analgesia with reduced analgesic consumption. But, it remains unknown if that analgesia is sufficient enough to blockade inflammatory stress response during perioperative time.We want to investigate and compare analgesic and immunomodulation efficacy of this two frequently used analgesics.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| clonidine | Active comparator | Drug: clonidine, levobupivacaineClonidine is an alpha2-adrenergic agonist with sedative, analgesic and hemodynamic properties. It inhibits transmission of nociceptive stimuli in the dorsal horn of the spinal cord, acting on the inhibitory descending pathways. |
| levobupivacaine | Active comparator | Drug: clonidine, levobupivacaineLevobupivacaine is long-acting local anesthetic, S-enantiomer of bupivacaine, with identical anesthetic potency. |
Who may qualify
- Ages
- 42 to 77 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- colorectal resection surgery patients
- preoperative risk of anesthesia and operation, ASA (American Society of Anesthesiologists) physical status I or II
Key exclusion criteria (6 listed)
- diabetes mellitus
- renal insufficiency
- liver insufficiency
- autoimmune disease
- corticosteroid and immunosuppressive use
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 |
|---|---|---|
| clonidine, levobupivacaineAlso: clonidine [Catapres®, Boehringer Ingelheim, Germany], levobupivacaine [Chirocaine®, Abbott S.p.A., Italy]One hour prior to skin incision, on epidural catheter, patients received 5 µg/kg of clonidine [Catapres®, Boehringer Ingelheim, Germany], 7 mL of 0.25% levobupivacaine [Chirocaine®, Abbott S.p.A., Italy] or 7 mL of saline.The study was designed to compare clonidine and levobupivacaine, and than both with the control group, in order to asses their analgesic and immunomodulation efficacy. | Drug | clonidine, levobupivacaine |
Primary outcome
postoperative pain level
Time frame: 1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
1 secondary outcome
systemic inflammatory stress response
Time frame: 1 hour before surgery, 1 hour after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery
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 17 Nov 2011.
- Background1. Buvanendran A, Kroin JS, Berger RA, Hallab NJ, Saha C et al.Anesthesiology 104(3):403-410, 2006. 2. Katz J. Curr Opin Anaesthesiol 15(4):435-441, 2002. 3. Carr DB. Anesthesiology 85(6): 1498-1499, 1996. 4. Lavand'homme PM, Eisenach JC. Pain 105(1-2):247-254, 2003. 5. Nader ND, Ignatowski TA, Kurek CJ, Knight PR, Spengler RN. Anesth Analg 93(2):363-369, 2001. 6. Wu CT, Jao SW, Borel CO, Yeh CC, Li CY, Lu CH et al. Anesth Analg 99(2):502-509, 2004. 7. Novak-Jankovic V, Bovill JG, Ihan A, Osredkar J. Eur J Anaesthesiology 17(1):50-56, 2000. 8. Kim MH, Hahn TH. Anesth Analg 90(6):1441-1444, 2000. 9. Louizos AA, Hadzilia SJ, Leandros E, Kouroukli IK, Georgiou LG et al. Surg Endosc 19(11):1503-1506, 2005. 10. Meisner M, Brunkhorst FM, Reith HB, Schmidt J, Lestin HG et al. Clin Chem Lab Med 38(10):989-995, 2000. 11. Naeini AE, Montazerolghaem S. Saudi Med J 27(3):422-424, 2006. 12. Sarbinowski R, Arvidsson S, Tylman M, Oresland T, Bengtsson A. Acta Anaesthesiol Scand 49(2):191-196, 2005.
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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.
Jasminka Persec, MD PhD principal investigator
Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
Zoran Persec, MD Msc study chair
Department of Urology, University Hospital Dubrava
Ino Husedzinovic, Prof. MD PhD study director
Anesthesiology, Resuscitation and Intensive Care Medicine Clinic, University Hospital Dubrava
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 clonidine, levobupivacaine in people with Analgesia and Pain, run by University Hospital Dubrava at 1 site in Croatia.
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 17 Nov 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 Croatia. 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?
postoperative pain level (time frame: 1 h before surgery, 1 h after start of the surgery, 1 h , 6 h , 12 h and 24 h after surgery). 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 NCT00860899, 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 17 Nov 2011.