HyperalgesiaPhase 3ICALPNCT00825422
Local Anesthetic Infiltration to Prevent Postoperative Pain After Lumbar Surgery
A Phase 3 study of Hyperalgesia, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hyperalgesia
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteFrance
- Study dates
- Jan 2009to Aug 2010
- 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 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Necessity to use safety contraceptive methods for women who can procreate
- Patients with American Society of Anesthesiologists physical status I, II or III
- Patients scheduled to undergo a posterior lumbar arthrodesis on one at three levels treated,
- Posterior lumbar arthrodesis is only executed on lumbar degenerative spine,
- A written informed consent has to sign by the patient and the investigator before beginning clinical study
- Patients affiliated with social security system
Who cannot join
- Pregnancy and breast-feeding
- Posterior lumbar arthrodesis exceeding three levels treated,
- Posterior lumbar arthrodesis post-traumatic or with neoplastic disorders or with the aim of correcting cord compression,
- Epilepsy not controlled through medication,
- Preoperative cognitive dysfunction or psychiatric disorders,
- Cardiac or breathing dysfunctions,
Show all 11Show fewer
- Preoperative opioid consumption,
- Patients who have a known local anesthetic, or morphine or/and acetaminophen allergy,
- Lack of understanding about the study or inability to use the patient controlled analgesic device,
- Patients protected by the law, guardianship,
- Patients who take a share in an another clinical study in the same time,
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Efficacy and Safety of Continuous Wound Infiltration With Local Anesthesics Through a Parietal Paravertebral Catheter for Postoperative Analgesia After Posterior Lumbar Arthrodesis
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures.
We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).
Read the detailed description
Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with local anesthetics may be beneficial in a multimodal approach to postoperative pain management after major surgery. The role of continuous wound parietal paravertebral infiltration of ropivacaine for pain relief and postoperative rehabilitation after posterior lumbar arthrodesis will be evaluated in a randomized, monocentric, double-blinded, superiority controlled trial.
The general purpose of this clinical research is the assessment of efficacy and safety of continuous wound infiltration with ropivacaine through a parietal paravertebral catheter for postoperative analgesia, and his repercussions at mid (two months) and long (six months)-term after posterior lumbar arthrodesis on degenerative spine.
The principal purpose concerns the assessment of postoperative analgesic efficacy at mid-term (two months after surgery) of continuous wound infiltration with ropivacaine (compared with saline solution), through a parietal paravertebral multi-holed catheter, after posterior lumbar arthrodesis.
After obtaining written informed consents, the patients scheduled to undergo posterior lumbar arthrodesis on degenerative spine,.will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B) when they will arrive in the operating room. The surgeon will perform a standardized posterior median incision at the level of lumbar intervertebral instability. Before putting retractors, he will infiltrate all surgical strata and the paraspinal muscles all long the wound bilaterally with a solution of ropivacaine 0.5% 20 mL (group A) or with a solution of 0,9% NaCl 20 ml (group B). At the end of surgery, a multi-holed wound catheter will be placed by the surgeon, under direct visualization, in the paravertebral space ; between the muscle fascia and subcutaneous tissues all along the wound, and fixed at the skin by a stitch. The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (5-ml bolus followed by an infusion of 8 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a prefilled elastomeric pump (400ml), set to deliver a 8-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. After the induction, the anaesthesist will install a peripheral venous catheter for each patient in order to make blood samples easier (eight peroperative and two postoperative blood samples for each patient, with the aim of ropivacaine pharmacokinetic study).
- Conditions
- Hyperalgesia
- Being tested
- Ropivacaine / Placebo
- Keywords
- Posterior lumbar arthrodesis, Degenerative spine, Postoperative analgesia, Local anesthesic, Continuous wound infusion catheter, Pain, lumbar vertebrae, Spinal fusion
- Medical subject headings
- Hyperalgesia, Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Ropivacaine / PlaceboDrug
Wound infiltration with local anesthesics/placebo through a parietal paravertebral catheter
| Study group | Role | What they receive |
|---|---|---|
| A | Experimental | first bolus of 20 ml of ropivacaine(5mg/ml) and continuous infiltration (8ml/h)of ropivacaine (2mg/ml) Receives: Drug: Ropivacaine / Placebo |
| B | Placebo comparator | first bolus of 20 ml of physiological saline solution(9%) and continuous infiltration (8ml/h)of physiological saline solution(9%) Receives: Drug: Ropivacaine / Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postoperative pain score : Visual Analog Scale (VAS)
Measured: Two months after surgery
Secondary outcomes (5)
Blood dosages of total ropivacaine
Measured: Peroperative
Clinical tolerances of catheter
Measured: until 5 days after surgery
Pain score :visual analog scale (VAS)
Measured: 24h, 48h, 5 days, 2 and 6 months after surgery
Static hyperalgesia using von Frey filaments
Measured: 48h, 5 days, 2 and 6 months after surgery
Postoperative rehabilitation neuropathic pain
Measured: 2 and 6 months after surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jan 2009 (estimated)
- Study startJan 2009
- Primary completionApr 2010
- Study completionAug 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HyperalgesiaStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Geneviève CHENE, Professor, Study chair, University Hospital, BordeauxCécile DEGRYSE, MD, Principal investigator, Univestity Hospital, Bordeaux
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00825422
- Sponsor's protocol ID
- CHUBX 2008/21
- Other IDs
- 2008-005696-10, 2008
- Acronym
- ICALP
- Status last verified
- Jun 2012
- First submitted
- 19 Jan 2009
- Last updated
- 19 May 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Efficacy and Safety of Continuous Wound Infiltration With Local Anesthesics Through a Parietal Paravertebral Catheter for Postoperative Analgesia After Posterior Lumbar Arthrodesis
- ClinicalTrials.gov ID
- NCT00825422
- Acronym / sponsor ID
- ICALP / CHUBX 2008/21
- Conditions
- Hyperalgesia
- Keywords
- Posterior lumbar arthrodesis, Degenerative spine, Postoperative analgesia, Local anesthesic, Continuous wound infusion catheter, Pain, lumbar vertebrae, Spinal fusion
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Apr 2010 (actual)
- Study completion
- Aug 2010 (actual)
- First posted
- 21 Jan 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.
Posterior lumbar arthrodesis causes severe postoperative pain, hampering patients's postoperative reconvalescence especially functional rehabilitation. Efficient and safe methods for postoperative analgesia are, therefore, mandatory. The application of opioids are the most frequently used therapies for postoperative pain relief but it very often results side effects. Local anesthetic wound infiltration is widely recognized as a useful adjunct in a multimodal approach to postoperative pain management. In the setting of spine surgery, a single bolus administration of a local anesthetic is a useful method (with a reduction in parenteral morphine consumption during the 48 first hours) but has a limited effect because of its short duration of action. Prolonged administration through a multi-holed catheter positioned by the surgeon at the end of the procedure could increase the duration of action and may thereby improve the efficacy of local wound infiltration. Easy and effective, this new modality of administration has expanded the indications for parietal infiltrations toward major painful procedures.
We designed this study to determine whether local anesthetic (compared with saline solution) continuous wound infiltration during the first two days after posterior lumbar arthrodesis on degenerative spine, could improve postoperative analgesia at short-term but particularly at mid-term (two months) and long-term (six months), in order to decrease postoperative lumbar pains (resulting in best life quality, opioid consumption limited and rehabilitation hastened) and postoperative hyperalgesia areas. The postoperative analgesic and antihyperalgesic efficacies; the postoperative rehabilitation at mid-term and long term, and the safety of opioid administration and multi-holed parietal catheter will be compared in the two groups (control and study).
Detailed description
Blockade of parietal nociceptive afferents by the use of continuous wound infiltration with local anesthetics may be beneficial in a multimodal approach to postoperative pain management after major surgery. The role of continuous wound parietal paravertebral infiltration of ropivacaine for pain relief and postoperative rehabilitation after posterior lumbar arthrodesis will be evaluated in a randomized, monocentric, double-blinded, superiority controlled trial.
The general purpose of this clinical research is the assessment of efficacy and safety of continuous wound infiltration with ropivacaine through a parietal paravertebral catheter for postoperative analgesia, and his repercussions at mid (two months) and long (six months)-term after posterior lumbar arthrodesis on degenerative spine.
The principal purpose concerns the assessment of postoperative analgesic efficacy at mid-term (two months after surgery) of continuous wound infiltration with ropivacaine (compared with saline solution), through a parietal paravertebral multi-holed catheter, after posterior lumbar arthrodesis.
After obtaining written informed consents, the patients scheduled to undergo posterior lumbar arthrodesis on degenerative spine,.will be randomly allocated to receive a continuous wound infusion of either 0.2% ropivacaine (ropivacaine group A) or 0.9% saline (control group B) when they will arrive in the operating room. The surgeon will perform a standardized posterior median incision at the level of lumbar intervertebral instability. Before putting retractors, he will infiltrate all surgical strata and the paraspinal muscles all long the wound bilaterally with a solution of ropivacaine 0.5% 20 mL (group A) or with a solution of 0,9% NaCl 20 ml (group B). At the end of surgery, a multi-holed wound catheter will be placed by the surgeon, under direct visualization, in the paravertebral space ; between the muscle fascia and subcutaneous tissues all along the wound, and fixed at the skin by a stitch. The patients will be thereafter randomly assigned to receive through the catheter either 0.2% ropivacaine (study group) (5-ml bolus followed by an infusion of 8 ml/h during 48 h) or the same protocol with 0.9% NaCl (control group), thanks to a prefilled elastomeric pump (400ml), set to deliver a 8-ml/h connected with the catheter. In addition, all patients will receive patient-controlled intravenous morphine analgesia. After the induction, the anaesthesist will install a peripheral venous catheter for each patient in order to make blood samples easier (eight peroperative and two postoperative blood samples for each patient, with the aim of ropivacaine pharmacokinetic study).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | Experimental | Drug: Ropivacaine / Placebofirst bolus of 20 ml of ropivacaine(5mg/ml) and continuous infiltration (8ml/h)of ropivacaine (2mg/ml) |
| B | Placebo comparator | Drug: Ropivacaine / Placebofirst bolus of 20 ml of physiological saline solution(9%) and continuous infiltration (8ml/h)of physiological saline solution(9%) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Necessity to use safety contraceptive methods for women who can procreate
- Patients with American Society of Anesthesiologists physical status I, II or III
- Patients scheduled to undergo a posterior lumbar arthrodesis on one at three levels treated,
- Posterior lumbar arthrodesis is only executed on lumbar degenerative spine,
- A written informed consent has to sign by the patient and the investigator before beginning clinical study
Key exclusion criteria (11 listed)
- Pregnancy and breast-feeding
- Posterior lumbar arthrodesis exceeding three levels treated,
- Posterior lumbar arthrodesis post-traumatic or with neoplastic disorders or with the aim of correcting cord compression,
- Epilepsy not controlled through medication,
- Preoperative cognitive dysfunction or psychiatric disorders,
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 |
|---|---|---|
| Ropivacaine / PlaceboWound infiltration with local anesthesics/placebo through a parietal paravertebral catheter | Drug | A, B |
Primary outcome
Postoperative pain score : Visual Analog Scale (VAS)
Time frame: Two months after surgery
5 secondary outcomes
Blood dosages of total ropivacaine
Time frame: Peroperative
Clinical tolerances of catheter
Time frame: until 5 days after surgery
Pain score :visual analog scale (VAS)
Time frame: 24h, 48h, 5 days, 2 and 6 months after surgery
Static hyperalgesia using von Frey filaments
Time frame: 48h, 5 days, 2 and 6 months after surgery
Postoperative rehabilitation neuropathic pain
Time frame: 2 and 6 months 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 19 May 2026.
Related trials for Hyperalgesia
Enrolling by invitationPhase 3
Open-Label Safety Study of AXS-14 in Subjects With Fibromyalgia
Fibromyalgia
Not yet recruiting
Photobiomodulation After Nonsurgical Root Canal Treatment
Symptomatic Apical Periodontitis, Postoperative Pain
RecruitingPhase 3
Fibromyalgia Response With Esreboxetine Evaluated Using a Randomized Withdrawal Research Design
Fibromyalgia
Recruiting
Offset Mechanisms in Evaluation of Lumbar Medial Branch Blocks
Pain, Chronic, Facet Joint Pain
Not yet recruitingObservational study
Perioperative Quantitative Sensory Testing and Incision Pain Mapping in Thoracic Surgery
Postoperative Pain, Chronic Postsurgical Pain
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.
Geneviève CHENE, Professor study chair
University Hospital, Bordeaux
Cécile DEGRYSE, MD principal investigator
Univestity Hospital, Bordeaux
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 of Hyperalgesia, run by University Hospital, Bordeaux at 1 site in France.
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 6 inclusion and 11 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 19 May 2026. 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 France. 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?
Postoperative pain score : Visual Analog Scale (VAS) (time frame: Two months after surgery). 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 19 May 2026.