CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
NCT Number: NCT01811251
The aim of the study is to show a decrease in postoperative pain during the first postoperative mobilization surgery lumbar disc herniation through a co-analgesia with a single dose of dexamethasone, pregabalin, or a combination of these two products.
Pain assessed by simple numerical scale will be also evaluated during the 48 first post-operative hours.
Determining an optimal co-analgesic protocol through the results of this study could help develop validation studies with larger scale such as a medico-economic component. In addition, these study protocols are easy to apply (ponctual administration) and inexpensive.
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Notify Me18 year–85 year
All sexes
Interventional
Phase 3
Clermont-Ferrand, 63003, France
Visit 1 (J-30 J-1): pre-inclusion visit During a follow-up visit usual pathology, the doctor will propose to the patient to participate in the protocol. Information Form will be given to the patient to be read at home to maintain a sufficient time for reflection. Physician investigator check the eligibility criteria and complete a pre-screening form where he will note the following information about the patient: No pre-enrollment, name, date, reason for non-inclusion appropriate.
Visit 2 (J-1): pre-anesthetic visit, the day before surgery During the pre-anesthetic routine consultation, the doctor will check the proper collection of informed consent and then inform the following information on the CRF: randomization number, age, height, weight, ideal weight theory, gender patient.
Visit 3 (J0): surgery One hour before surgery, the patient will receive, according to randomization, premedication with pregabalin LYRICA ® or placebo orally.
Then the patient will be conducted in the operating room for induction of general anesthesia and surgery. Immediately after induction of anesthesia, depending on randomization, the patient will receive intravenous dexamethasone or placebo.
At the end of surgery, the patient is conducted in Post Anaesthesia Carry Unit (PACU) to be extubated and receive routine care after surgery.
Extubation of the patient, denoted H0 represents the time when the measurement begins.
The data collected from H0 are :
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
informed consent, the collection of endpoints, the use of auto-controlled analgesia.
Time frame: at H0+2H, at H0+6h, at H0+12h, at H0+24h, at H0+48h
Time frame: at J0+1 day
Time frame: during the first mobilization with standing up at J1
Time frame: at J0+1day
Time frame: at J0+1 day
Time frame: between H0+2h and H0+24h
Time frame: at J0+180 days
Time frame: at J0+180 days
Time frame: at J0+180 days
Time frame: at J0+180 days
Time frame: at H0+24h
Time frame: at H0+48h
Time frame: at J0 at the arrival in the operating room
Time frame: at J0 at the end of SSPI
Time frame: at H0+24 h
Time frame: at H0+48h
Time frame: at H0, between H0 and H0+48H
Time frame: at H0, between H0 and H0+48H
Time frame: at H0, between H0 and H0+48H
Time frame: at H0, between H0 and H0+48H
Time frame: at H0+0h30
Time frame: at H0+1h
Time frame: at H0+1h30
Time frame: at H0+2h
Time frame: at H0+6h
Time frame: at H0+12h
Time frame: at H0+24h
Time frame: at H0+48h
University Hospital, Clermont-Ferrand
Other
Acronym: DEXA-PG-HD
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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