PROTOCOLE D’ANALGESIE POST OPERATOIRE PAR INFILTRATION CONTINUE DE ROPIVACAINE DANS LES ARTHRODESES DU RACHIS LOMBAIRE

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-004705-34-FR

Enrollment

Registered

2008-09-11

Start date

2008-10-01

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthrodese of the lumbar rachis by posterior way

Interventions

Trade Name: NAROPEINE (7,5 mg/ml) Product Name: ROPIVACAINE 0.5% Pharmaceutical Form: Injection* Trade Name: NAROPEINE (2 mg/ml) Product Name: ROPIVACAINE 0.5% Pharmaceutical Form: Injection*

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: - Patients benefiting from of arthrodesis scheduled by a rachis lumbar posterior way - Older than 18 years old - Heavier than 50 kg - Patients in the state health scheme - Patients having signed consent Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: - Surgery linked to an infectious, tumoral or traumatological cause - Patients suffering of chronic pain define as patients consuming stage 3 analgesic since more than 3 months. - Patients receiving isoptine or flécaïne before surgery - Arthrodesis on more than 3 stages - Impossibility of cooperate with the patient - Contra-indication for the maintain or the installation of a catheter diffusing analgesic - Contra-indication of using local analgesic

Design outcomes

Primary

Measure	Time frame
Main Objective: Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours. ;Secondary Objective: - Compare between 2 groups the consumption of morphine since J0 to J2 - Estimate the rates of the nausea and the postoperative vomits in 2 groups - Compare between 2 groups the delay up to the first rise - Estimate the quality of sleep - Compare the duration of the stay in hospital - Estimate in 2 groups the level pain at 3 months and at 6 months the surgery after. ;Primary end point(s): Primary: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48. Secondary: - The consumption of morphine mg (24 H and 48 H after surgery) - The rate of the nausea and the postoperative vomits defined as the number of patients presenting the symptom on the number of patients in the group. - Delay up to the first rise - Delay will be estimated in hours enter the end of the intervention surgery and the first one night - The quality of the sleep estimated every morning with an analogical visual scale from 0 (very bad quality of sleep) to 10 (excellent quality of sleep) - The duration of stay: calculated in days as the delay between the end of the intervention and the capacity at the exit. - Recall of the patients in 3 and 6 months after the surgery to estimate the persistence of residual pains and if they still consume opioid. We shall ask to the patient to clarify the presence or the absence of pain	—

Measure

Time frame

Main Objective: Compare the evolution of the postoperative levels of pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving a single bolus of analgesic, one receiving a single bolus of analgesic and an infiltration of Ropivacaine during 48 hours. ;Secondary Objective: - Compare between 2 groups the consumption of morphine since J0 to J2 - Estimate the rates of the nausea and the postoperative vomits in 2 groups - Compare between 2 groups the delay up to the first rise - Estimate the quality of sleep - Compare the duration of the stay in hospital - Estimate in 2 groups the level pain at 3 months and at 6 months the surgery after. ;Primary end point(s): Primary: We compare the pain between 2 groups by means of the EVA (score of 0 for absence of pain in 10 for conceivable maximal pain) measured at H2, H8, H16, H24, H48. Secondary: - The consumption of morphine mg (24 H and 48 H after surgery) - The rate of the nausea and the postoperative vomits defined as the number of patients presenting the symptom on the number of patients in the group. - Delay up to the first rise - Delay will be estimated in hours enter the end of the intervention surgery and the first one night - The quality of the sleep estimated every morning with an analogical visual scale from 0 (very bad quality of sleep) to 10 (excellent quality of sleep) - The duration of stay: calculated in days as the delay between the end of the intervention and the capacity at the exit. - Recall of the patients in 3 and 6 months after the surgery to estimate the persistence of residual pains and if they still consume opioid. We shall ask to the patient to clarify the presence or the absence of pain

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Countries

France

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026