Clinical Trial Details
— Status: Terminated
Administrative data
| NCT number |
NCT00823576 |
| Other study ID # |
08-CIR-03 |
| Secondary ID |
|
| Status |
Terminated |
| Phase |
Phase 4
|
| First received |
|
| Last updated |
|
| Start date |
December 2008 |
| Est. completion date |
March 2011 |
Study information
| Verified date |
January 2009 |
| Source |
Centre Hospitalier Universitaire de Nice |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical Trial Summary
Because local anesthetic infiltration has not been comparated to continuous infusion after
spine fusion surgery, the investigators designed this study to determine whether this
technique could enhance analgesia and improve patient outcome after posterior lumbar
arthrodesis.
The Main Objective of the study is to compare the evolution of the postoperative levels of
pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an
infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot
infiltration and a continuous infiltration of Ropivacaine during 48 hours.
In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,
and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.
The secondary outcomes are the consumption of morphine,the rate of the nausea and the
postoperative vomits, the delay up to the first rise, the quality of the sleep, the duration
of hospital stay and the persistence of residual pain.
Description:
Postoperative pain after posterior lumbar stabilization surgery is related to soft tissue and
muscle dissection and to manipulations and removal at the operation site. Most patients
complain of severe pain at rest during the first 24 h after surgery. This pain increases
considerably with mobilization because of the reflex spasm of paraspinal muscles that is
triggered by the primary wound pain. During the following 48-72 h, postoperative back pain is
generally moderate at rest, whereas it remains severe on movement and produces discomfort
that can interfere with patient mobilization and, possibly, with discharge time. Despite the
favourable effects of analgesia in the early postoperative period, this drug association may
produce a number of well-known side effects, such as nausea, vomiting, respiratory
depression, sedation, renal abnormality, and upper gastrointestinal and operative site
bleeding. Local anesthetic infiltration of the surgical wound is a useful method in the
treatment of postoperative pain after various surgical procedures. Ropivacaine is an
interesting molecule for infiltration because of its vasoconstrictive properties and
decreased neuro- and cardiotoxicity compared with bupivacaine.
The Main Objective of the study is to compare the evolution of the postoperative levels of
pain until J2, in the scheduled lumbar surgery between 2 groups of patients, one receiving an
infiltration "single shot" of local analgesic (Ropivacaïne), one receiving a single shot
infiltration and a continuous infiltration of Ropivacaine during 48 hours.
After we obtained approval from the ethics committee and informed, written consent from
patients, patients older than 18 years old , heavier than 50 kg, without psychological
disorders, benefiting from of arthrodesis scheduled by a rachis lumbar posterior way were
enrolled.
Patients were randomized to one of the two following postoperative analgesia groups after a
presealed envelope was opened.
Post operative pain management is standardised with paracetamol, profenid and ACP morphine
for each patient.
In both groups the wound was infiltrated with a solution of ropivacaine 0.5% 200 mg/40 mL,
and in one group an infusion of ropivacaine 0.2% 5 mL/h was maintained for 48 h.
The Main Objective of the study is to 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.
The secondary outcomes are:
- The consumption of morphine 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 The amount of analgesics required and the
local and systemic adverse events were recorded for each patient.
Discharge was decided by the surgeons according to the following discharge criteria:1)
satisfactory pain control for self-mobility; 2) uncomplicated wound-healing process 3) no
impairments in haemoglobin 4) normothermie 5) normal transit, no nausea and vomit.
Sample-size calculation was based on an expected difference of 20 mm in VAS measurements for
pain between groups. We calculate we need 64 patients for our main outcome. Each patient will
be monitored during 6 month after the surgery.
The length of the study is 2 years.
