Overview

Co-analgesic Effects of Dexamethasone and Pregabalin After Lumbar Slipped Disc Surgery

Status:
Completed
Trial end date:
2017-10-10
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
University Hospital, Clermont-Ferrand
Treatments:
Analgesics
BB 1101
Dexamethasone
Dexamethasone 21-phosphate
Dexamethasone acetate
Pregabalin
Criteria
Inclusion Criteria:

- Patients undergoing a lumbar slipped disc surgery

- Aged 18 to 85 years.

- ASA score I-III

- Having given their consent.

- Affiliated with a social security scheme

Exclusion Criteria:

- Patients who must be operated urgently.

- Patients previously operated for lumbar spinal surgery.

- Expected duration of surgery more than 3 hours.

- Severe renal impairment defined by a creatinine clearance less than or equal to 30
mL/min.

- Taking long-term strong opiates .

- Taking long-term corticosteroids or within 48 hours before surgery.

- Taking pregabalin or gabapentin within 48 hours before surgery.

- Drug addiction.

- Patients with cognitive impairment (judged by the investigator) that may interfere
with:

informed consent, the collection of endpoints, the use of auto-controlled analgesia.

- Pregnant or nursing women.

- Refusal of the protocol.

- Minor or major protected patients.

- Allergy or other cons-indication to the molecules used in the protocol.